ISO 14001:2004 Environment Management System

ISO 9001 Standard - ISO 9001 Standards

2012-01-03T04:49:00.000-08:00

ISO 9001 Standard - ISO 9001 Standards

Integrating Management Systems Within The ISO 9001 Standards

2011-10-01T07:01:00.001-07:00

Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8?700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO 9000 Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430?000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)

Improve your performance management with new version of ISO 9001

2011-10-01T06:59:00.000-07:00

A quality management system enables you to manage your business processes effectively:

it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.

The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.

There are three main objectives to the new standard:

Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)

Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)

There are no new requirements in the new standard:

The title, scope, and structure of the standard are unchanged

The process approach is confirmed

Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon

Preservation of the quality management principles included in ISO 9000:2000

There are five main areas to note. The relevant sections of the standard are noted in brackets.

1. A reinforcement of the notion of product conformity

2. Compatibility with other standards is evolving

3. A better understanding of outsourced processes

4. An editorial clarification of some requirements – for instance;

A reinforcement of the notion of product conformity2.3.4.

An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving

• (6.4) work environment, including an explanatory note on work environment giving examples,

to help meet product conformity requirements

• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond

satisfaction surveys to include other channels such as customer feedback5.

• (Introduction) the notion of risk

• (5.5.2) appointment of a management représentative

• (6.2.2) assessing the effectiveness of achieving compétence

• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?

Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity

Implementing ISO 9001 Standards

2011-10-01T06:58:00.000-07:00

Implementing ISO 9001 standards

If you have your own business and now you are looking for ISO 9001 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9001 Standards developed many quality standards as per different -different business areas.

ISO 9001 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.

For implementing ISO 9001 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards

An ISO consultant performs the various activities and explains the course objectives :

• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship

• describe the purpose of Quality Management Systems and 8 Quality Management Principles

• Interpret the ISO 9001: 2008 in the context of audit

•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems

• Develop understanding of Roles & Responsibilities of Lead Auditors

Hiring a Consultant is a better and easiest way to implement ISO in your organization

Management Review IN ISO 9001 Standard

2011-06-22T06:11:00.000-07:00

One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check sheet can also be used to keep track of attendance and log feedback that is generated during the meeting.

Read more on ISO 9001 Standards at http://www.iso9001store.com

ISO 9000 Document Management Software System

2011-06-01T06:02:00.001-07:00

Today’s manufacturing companies that seek ISO 9001 compliance-(regardless of their motivation to do so) probably don’t find it that difficult to create intelligent documentation. After all, a few days with a good consultant or a quality manager can take care of document creation. The problem lies in the gap between what employees are doing and what employees are supposed to be doing (in terms of adhering to documentation) and the gap between the manner in which processes are being implemented and the manner in which they should be implemented ( in accordance with documentation). In other words, the problem lies in the way processes are strategized and applied and in the way employees commit to standards when compared against existing documentation. How can a company overcome these issues? The answers may be simpler than you think.

Automation is the Answer for ISO Control
If your underlying processes are poorly strategized then an automated document management software system won’t be of much use. However, once the processes have been effectively planned (and applied) a document management software system can speed process-to-process management by leaps and bounds. Companies that automate not only to comply with ISO standards but to generate more revenue by performing less administrative labor save weeks and even years worth of time just by automating their processes and documentation control with a document management software system.

Making Amends
The right document management software system and ISO document control would also allow companies to find deviations and nonconformance events faster and move those events to resolution phases in a small fraction of the time they were originally routed—if they were routed at all. Some ISO 9000 document management software systems may even be combined with a CAPA QMS solution. This is especially valuable when determining the root cause of major to minor deviations.

A Document Management Software System and Employee Training
ISO standards do not require any type of automation but ISO standards lend themselves to automation in a way that’s quite remarkable. Take for instance the following document management requirements from the official ISO 9001 International Standard.

ISO 9001 Section 4.2.3
ISO standards make it clear that ISO 9001 “approved” companies must define (i.e., document) how they will approve documentation, how they will identify documentation changes, how they will update/reapprove revised documentation, how external documentation will be managed and how assurance will be provided that documentation will be available when it is required. 1 And that’s only a shadow of things to come! A document management software system designed for strict compliance can automate the approval of documentation, the identification of document changes, updates and reapproval notifications, external documentation management and high-level document security. Some solutions also integrate training and online exams as well.

How Much Could You Save?
Chances are high that automation will save you thousands, tens of thousands or even hundreds of thousands of dollars annually depending on the size of your company. Just foregoing a typical document routing process (a manual process) can save many employees fruitless trips back and forth from one office to another. Who wouldn’t want to avoid those time consuming searches through 3-ring binders and lost documentation due to employee absence or neglect?

Conclusion
Regulation and control are the future for manufacturing. Gone are the days of free experimentation and a blind eye toward material waste. Today is the day of premeditated design, quality assurance and web-based automation. If your company plans to be, or already is, compliant with ISO 9001 standards why not consider automating those ISO 9001 controls with a document management software system.

Risk Management In ISO 9000 Standard

2011-03-26T15:36:00.000-07:00

In each human endeavour there is an element of risk; personal, project or financial, or a combination of them all. The job of the responsible individual is to identify the risk and act accordingly. We all do these ‘risky’ things, almost daily, aware that we are taking a risk. Rather than staying away from the risk we become adept at identifying it and having a strategy for dealing with it if the risk materialises. This is what risk management is about, and is an ability that is important in virtually every endeavour.

The popular misconception that risk management is difficult or complicated stems from the bureaucratic methodology of some system-oriented organisations and managers. It is neither complicated or bureaucratic, and need not be. Risk management is basically a simple proposition with a complexity dictated by the nature of the situation to which it applies – usually a project, and the parties involved. In its basic form risk management involves:

1. Identifying risk – Looking for anything that threatens the successful completion of the project against the original requirement. Risks can be environmental, organisational, technical, legal, economic or commercial.

2. Counteracting risk – Taking action to remove or reduce the probability of a risk being realised. The response depends on the nature or seriousness of the risk.

3. Acting when the risk event occurs – Invoking whatever contingency measures were devised for the risk that has materialised.

And for this to happen needs:

4. Monitoring at all stages – This typically means documenting a risk assessment in a profile that identifies the risk, the probability of its occurrence, and the impact if it does materialise. Factors that score paramount are those that require the greatest attention and monitoring. A good risk manager will devise contingency plans that reduce either the probability or the impact of these occurrences, and so remove them from the scene.

Working within a formal structured management system similar to that defined by ISO 9000 requires the application of risk assessment practices to satisfy the requirements of the Standard. Auditors of such systems may not find specific references to risk management in these areas even though the identification of potential failure (8.5.3) is wholly concerned with a topic that is nothing less than risk management.

Well managed risk taking is an essential feature of any forward thinking enterprise, since risk is an element of any progression or advancement. It is the adoption of effective risk management in conjunction with the continuing need to drive forward from a comfortable position that leads to progress and advancement. Doing what we always do purely because the risks appear to be negligible or are well known is to be ‘risk averse’, and for progressive organisations cannot be acceptable. Neither is it acceptable to pursue new ideas without an understanding of their potential benefit, proper planning, a clear idea of the threats to these benefits being achieved , and a strategy for dealing with them should they materialise. We need to manage in a manner that is neither predictable or reckless. Risk assessment is an essential tool to support this strategy.

ISO 9000 Document Management Software System

2011-01-30T15:16:00.000-08:00

Changes in ISO 9001:2008 Quality Standard

2011-01-30T15:15:00.000-08:00

According to a joint announcement by the ISO (International Organization for Standardization) and the IAF (International Accreditation Forum), the two organizations have agreed to an implementation plan for a smooth migration to ISO 9001:2008.

1) Certification to ISO 9001:2008 will only be issued after publication of ISO 9001:2008 (expected before the end of 2008) and after a routine surveillance audit or re-certification audit against ISO 9001:2008.

2) One year after publication of ISO 9001:2008, all certifications issued (new certifications and

re-certifications) must be to ISO 9001:2008.

3) Two years after publication of ISO 9001:2008, existing ISO 9001:2000 certifications will not be valid.

This transition plan is possible, because ISO and IAF have agreed that ISO 9001:2008 introduces no new requirements. The revised quality standard only introduces clarifications to the existing ISO 9001:2008 requirements, and changes to improve consistency with ISO 14001:2004, the environmental standard.

ISO14001: A Deterrent against Environmental Degradation

2010-10-27T07:02:00.001-07:00

ISO14001: A Deterrent against Environmental Degradation

Over the last few years, ISO 14001 has gained considerable support of business communities and governments worldwide. Business communities consider it a catalyst which ensures continued business and provides an opportunity to boost trade with customers overseas. Governments look at it as a useful agent to soften the local industry to comply with environmental legislation.

ISO 14001 is being pushed as an agenda, therefore, which will help in lowering environmental impacts that occur because of the manufacturing sector. On the surface, the picture is quite rosy.

For large manufacturers adopting ISO 14001 is quite practical and makes economic sense. The major assumption while formulating the ISO 14001 was that there is no informal manufacturing sector (because of poor representation and inactive role of the developing countries at TC207). Informal sector in Pakistan is a major component of the manufacturing sector and provides useful support to the formal sector. The informal sector exists within the populated areas, making it extremely hard to regulate. Therefore, the environmental impacts due to this sector are quite significant.

ISO 14001 requires the suppliers of a manufacturer to have an Environmental Management System (EMS) in place as well. For a supplier operating from a small facility in a congested area and meager resources, how can s/he be expected to hire a consultant to develop an EMS? In a country which has a significant informal manufacturing sector, high unemployment due to deteriorating economic condition, high inflation, limited resources, weak monitoring agencies and deteriorating infra-structure, with all these constraints, how is it possible for the manufacturing sector to adopt ISO 14001 in it’s true spirit?

Even if a manufacturer adopts the ISO 14001, what is the guarantee that s/he will get business? What is the incentive for the non-exporting manufacturers to adopt ISO 14001? How can the industry be convinced that ISO 14001 is an opportunity not an obstacle? Considering all these factors, this paper will analyze the current status of ISO 14001 adoption in Pakistan, reasons for adoption, deterrents in adoption, and recommendations on how those deterrents can either be removed or minimized, and it’s overall impact on the environment and economy.

Process Approach In ISO 9001 Standards

2010-10-27T07:01:00.000-07:00

Process Approach In ISO 9001 Standards

The ISO 9001 International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of added value,

c) obtaining results of process performance and effectiveness, and

d) continual improvement of processes based on objective measurement

ISO 9001 Standards & ISO 14001 Standards

2010-10-27T07:00:00.000-07:00

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

What is ‘Root Cause Analysis’ In ISO 9001 Standards?

2010-08-31T05:39:00.001-07:00

What is ‘Root Cause Analysis’ In ISO 9001 Standards?
Suppose you come across a dandelion weed while in your garden. (If you have as little time in the garden as I do, at times you may find too many!) You pull off the head of the dandelion and all the leaves. There – you can’t see it any more.
The question is: does this fix the problem?
To illustrate, let me share some findings from an audit in a type of courier company. They collect & deliver items for their customers, and have contracts with large customers. If any customer complaints arise, the operations manager must respond in writing.
For audit, I chose a sample of complaints from the last 3 months and looked at what they’d done with them. Most complaints were for late/missed pick-ups or deliveries.
Some sample responses from the manager to the client:
A. This route has too many sites on it, we are looking at changing it.’
B. ‘The entry disappeared from the system. It was re-entered, and the pick-up went ahead the next day.’
C. ‘The driver was new and didn’t know. He has been spoken to.’ (A week later, the same driver missed another pick-up for the same customer.) ‘He no longer works for us.’
D. ‘I can only assume this happened while I was on leave, and the supervisor didn’t know he had to respond to your calls urgently.’

And my favourite E: ‘The driver was late because there were delays during the day.’
These responses are typical of just looking at symptoms: pulling off the dandelion leaves. That approach leaves the root of the problem still intact. Like the dandelion, you can pretty much bank on the fact that it’s going to come up again. And again. And again. Until you do something to find the real cause (or causes). That’s effective root cause analysis, because you get to the root: the real underlying cause.
For example: Why does a route have ‘too many sites’ on it? What does ‘looking at changing it’ mean? Has it been done? If it was changed, did the changes work? If not, when will it be done? How did that route get ‘too many sites’ on it? And what would stop that happening again, or on another route?
Consider the ‘new’ driver: Why didn’t he know what to do? Had he received the information he needed such as induction and training? If not, why not? Why is ‘speaking to’ a driver adequate to prevent recurrence? (it’s not) Has the company reviewed how it selects its drivers? Because the recurrence a week is a strong sign of inadequate cause analysis and ineffective corrective action.
Why Find the Root Cause?
Most organisations are busy and somewhat chaotic. Immediacy often rules. So there’s often a tendency to go for the quick fix – treat the symptom rather than the real, underlying cause. The driver is ‘spoken to’, the order ‘re-entered into the system’. But this almost guarantees the same or very similar situation will recur, and have to be dealt with again. And again.
When problems come up in your organisation – which they will – you can choose how to respond. You can look for someone to blame and stop at the symptom (‘the driver was new… the supervisor didn’t know… it disappeared from the system’). Quite apart from the damage it causes to personnel relations, this approach isn’t effective.
An organisation with an intelligent approach to quality knows the value of a systematic approach to problems, including root cause analysis. The best question is: What can we learn from this situation? And then: How can we apply that learning to improve?
When Should You Use Root Cause Analysis?
If you have or aspire to ISO 9001, you must have a systematic approach to problems: nonconformance, corrective and preventive action. Without it, you’ll find it hard to pick problems for root cause analysis, because they’re often distributed over time (so you don’t realize they recur), or happen to different people (so you don’t realise they recur in your organisation).
Good candidates for root cause analysis are the situations that recur most often, and use the most resources to rectify or those that cause the most damage when they do.
Remove the Root Cause or Not?
After you’ve identified the root cause/s, you have to decide if it’s worth removing the root cause or whether you continue to treat the symptoms. This isn’t always an easy decision.
It’s often relatively easy to estimate the cost of removing the root cause, but less easy to assess the cost of not doing so. Suppose, for example, a truck breakdown turns out to have been caused by ineffective maintenance by a supplier. And suppose that supplier costs $10,000 less per year than the other. Superficially, the cost vs savings looks good.
But suppose that also means a truck off the road for at least an extra 5 days a year – and your largest customer got so angry about one too many crucial but failed pick-ups that they don’t renew your contract. And tell everyone what an unreliable company you are.

How To Write ISO 9001 Standards Procedures?

2010-08-31T05:38:00.000-07:00

How To Write ISO 9001 Standards Procedures?

Step 1
Place the following sub sections into your procedure:
Purpose, Scope, Definitions, Associated Documentation, Responsibility/Authority, Procedure, Record Retention and Attachments. Leave blank spaces between each to add the required information.
Step 2
First, start with the Purpose Section. Describe the reason why the procedure exists. If we use the purchasing procedure as an example the Purpose might read:
“This procedure defines the process for obtaining raw materials and supplies for XYZ Company and the matter with which the requirements of these purchases are flowed down to XYZ Company’s suppliers.”
Step 3
ScopeNext, define the scope of the document. This is to what extent the process will reach within the company. For example:
“This procedure shall include all purchases directly used in the manufacture or processing of XYZ Company’s product.”
Step 4
Next make a list of terms and definitions. These should not be common terms that anyone reading the document should already know; but, should be technical terms that pertain to the procedure or common terms that may have added meaning to the company. For example:
“Supplier – XYZ Company defines a supplier as an approved company that supplies items used to produce and/or manufacture our product. This term does not include companies that supply general office product not used to produce or process XYZ Company’s products.”
In this example the common term supplier has added meaning to XYZ Company that could differ from another company’s definition of supplier. To avoid confusion a definition of the term is listed in the definitions section of the ISO 9001 procedure.
Step 5
Define the supporting document that are needed to create a complete process. If you product calls out t use only approved suppliers it may be nice to reference the supplier management procedure and the approved supplier list; because, they will be needed to complete the purchasing process.
Step 6
Now define the responsibilities and authorities. This is similar to a job description where as it defines the person that will manage and/or carry out the tasks described in the procedure. For example:
“The purchasing manager will be responsible for managing this procedure and coordinating purchases. Managing shall include the implementation and enforcement of this procedure throughout XYZ Company.”
Step 7
Define the procedure. This is the bulk of the procedure and is where the company will define the actual process. This can be detailed or simply call out what work inspection are to be used at each step of the purchasing process. It is important that all the elements of the quality standard that pertain to the procedure are defined in this part of the document. This section is usually broken into subsections. In our “Purchasing Procedure” example this might include “General procedures”, “Purchasing Components and Raw Materials” and “Purchasing Outside Services”. Usually some kind of outline method is used to layout this section.
Step 8
Next is the record retention section. This usually defines the method of controlling records related to this process. Where they will be kept, How long they will be kept, in what type of media for which they will be stored.
Step 9
Finally, the attachments section of the procedure will be defined. This will be references to other procedures, external information sources or other media used to supplement that procedure itself.

Records Required by ISO 9001 Standard

2010-08-31T05:37:00.000-07:00

Records Required by ISO 9001 Standard
ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.
Questions you may have include:
•What is a record?
•What are the required records?
•What is the reason for these records?
This lesson will answer those questions. There is a mini-quiz near the end of the lesson.
What is a record?
Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.
Records required
The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.
Para.
Record Required
5.6.1
Management reviews
6.2.2 (e)
Education, training, skills and experience
7.1 (d)
Evidence that the realization processes and resulting product fulfill requirements
7.2.2
Results of the review of the requirements relating to the product and actions arising from the review
7.3.2
Design and development inputs
7.3.4
Results of design and development reviews and any necessary action
7.3.5
Results of design and development verification and any necessary action
7.3.6
Results of design and development validation and any necessary action
7.3.7
Results of the review of design and development changes and any necessary action
7.4.1
Results of supplier evaluations and actions arising from evaluations
7.5.2 (d)
As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output
7.5.3
Unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged, or otherwise found to be unsuitable for use
7.6 (a)
Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6
Validity of previous results when measuring equipment is found not to conform to its requirements
7.6
Results of calibration or verification of measuring equipment
8.2.2
Internal audit results
8.2.4
Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2
Results of corrective actions
8.5.3
Results of preventive actions
Reason for records
The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.

ISO 9001 Standards Gap Analysis

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ISO 9001 Standards Gap Analysis

One of the first steps in implementing ISO 9000 is to perform a gap analysis. This is the technical name for an initial comparison of the Quality Management System to the ISO 9001:2008 Standard. The goal in find the gap between the standard and the QMS. The Gap Analysis will establish the scope of the implementation project and will therefore be important information for determining the amount of resources that will be required to complete the project in the given timeline.
Typically the gap analysis is based on a Gap Analysis checklist. These can be purchased from several different sources on the web ( like theISOstore.com). A second option is to use the internal audit checklist from this web site as a gap analysis checklist. Either way, the key to have a list of questions based on the standard that will uncover any weaknesses in the QMS before the project begins.
Gap Analysis Auditors
Performing gap analysis is best done by someone who is familiar with the ISO 9001 standard. If the company has no one with this experience, then consider outside training for the person who will be the lead internal auditor. Without grasping the goals behind the standard, you and your company can waste a lot of time improperly documenting flaws and over engineering solutions.
Performing a Gap Analysis
I recommend performing a basic ISO 9000 awareness training before the gap analysis. The awareness training will help reduce fear or resistance to the change that sometimes comes with a large company wide project. Once everyone understands the goals of the ISO project and is ready to be audited, start the gap analysis in sections. Covering sections 4,5,6,7 and 8 all in one audit is a mind melting experience. Start with section 4 to see how fast you can properly document the a section. Then schedule the remaining section based on your experience.
As you go through each section, you will either find that a system is already in place that meets the requirements of the ISO9001 standard or you will write a finding for that section. If you find that the system is in place, simply log the document numbers on the gap analysis sheet and move on. If you find that a large portions of the quality systems are missing, then you can write the equivalent of a major finding with a larger scope and not waste too much time listing every detail of what is missing.
How to use the result of the gap analysis
Once you have completed the gap analysis, you will have a list of missing or under-developed documents, records and systems. If you use the checklist from this web site, the result of the gap analysis will be a list of individual item that must be corrected. If the check sheet said “what document is used to the describe record retention?” and you found no document, then the document should be created. Once you feel that everything is in place, then you will want to repeat the audit to confirm that you can answer every question on the internal audit checklist with a positive response.
If the gap analysis show that your systems are in relatively good shape with some area for improvement, then I would make the gap analysis the first record in your internal audit notebook. This will help build a history of audits. If the gap analysis shows major flaws, you may want to fix them and then perform an internal audit as the first record to meet your internal auditing requirements. External auditor will frequently look at your internal auditing records to see if there are any blatant problems with the QMS, so don’t make their job too easy.

ESTABLISHING THE INITIAL STATE OF THE QUALITY MANAGEMENT SYSTEM

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The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.

According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.

However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the

existence and functionality the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results. A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:

1. Complete Death: No documentation, no functioning This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product. Relatively few companies will find themselves in this situation.

2. Informally Alive: No documentation, some level of functioning Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” . SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.

3. Formally Death: Some level of documentation, no functioning SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.

4. Formally Alive: Some level of documentation, some level of functioning Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. As illustrated in Figure 2, this situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.

Integrating Management Systems Within The ISO 9001 Standards

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Integrating Management Systems Within The ISO 9001 Standards

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)

ISO 9000 Standards Document control procedures

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ISO 9000 Standards Document control procedures
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

Documentation Structure For ISO 14001 EMS

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ISO 14001 Standard does not require an Environmental Manual. Despite this, almost all companies I worked with developed and used EMS Manuals. Many of our clients use a four-level structures, including records, as shown below:
Manual – level 1
Procedures – level 2
Instructions – level 3
EMS Records – level 4
While auditing EMS systems like the one above, I often asked clients about the position of their Environmental policy in this structure. If you start from an Environmental Manual, how would you know what standard this manual should cover? The Environmental policy defines it and therefore it may be included into the structure:
Policy – level 1
EMS Manual – level 2
ISO 14001 Procedures – level 3
Work Instructions – level 4
EMS Records – level 5

Environmental Aspects In ISO 14001 Standards EMS

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Environmental Aspects In ISO 14001 Standards EMS

First make lists of the environmental aspects (issues) that are relevant

to the business. The environmental review mentioned earlier should

provide most of this information and the Annex to ISO 14001 provides

guidance on the format for doing this.

Consider the inputs, outputs and processes/activities of the business in

relation to;

a) emissions to air

b) releases to water

c) waste management

d) contamination of land

e) use of raw materials and natural resources

f) other local environmental and community issues

Consider both site (direct) and offsite (ie. indirect) aspects that you

control or have influence over (such as suppliers) and in relation to

normal operations, shut-down and start-up conditions and reasonably

foreseeable and emergencies situations

A simple written procedure is then required to determine which of the

aspects identified are really or probably significant (important) and should

therefore be managed by the EMS. This process which is

similar to health and safety risk assessment ranks the aspects by order

of importance and the significant aspects identified are then the core

of the environmental management system.

There are various methods of determining significance but most are

based on the principle of attributing a relative value for the

environmental hazard or potential to cause harm (eg. on a scale of 1-

5) and the risk or likelihood of occurrence (eg. on a scale of 1-5). The

relative significance is then determined by multiplying the hazard by

the risk. (eg. max score of 25). An arbitrary but cautious threshold

value is then set above which environmental aspects are considered to

be significant. This threshold can be determined by a common sense

consideration of the aspects identified.

ISO 14001 Standard & Environmental Issues

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ISO 14001 Standard & Environmental Issues

ISO 14001 is a systematic tool that enables an organization in any market sector to focus on their situation, identify the relevant environmental issues and to lessen their impact to their benefit and the environment. It is part of a global response to the recognition that we are damaging the environment in which we all live. The cause and effect of the foremost world environmental issues, which are all due to mankind, are generally too vast and too intangible for us to grasp and so the slightly cliché expression ‘think global, act local’ is very relevant. Once the EMS is implemented and to become registered to ISO 14001, the external auditor will assess your EMS in two separate stages, on site. The first stage to understand your business activities and determine formal readiness for assessment and the second to check practical compliance with ISO 14001. After registration he will return at regular intervals every year to verify continual improvement and regulatory compliance, against your set objectives and your EMS. The external auditor should be seen as a wise friend, not a policeman. He should certainly explain his findings and assist the company to find ISO 14001 registration is not a cure for all environmental problems but I hope I’ve demonstrated that it is a worthwhile, if not essential business initiative that could enable your management to better manage your business, gain commercial advantage and minimize its environmental impact.

ISO 14001 Standards Environmental Management System

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Global warming, ozone depletion, pollution and extinction of numerous species of animals. These are just a few of the environmental issues that the world faces, in the name of development. As responsible corporate citizens, SMEs can play their part in preserving our natural environment for our next generation.

Both individuals and businesses especially have a social and environmental responsibility to fulfil. With the rapid development in today’s industrialised world, the issue of preserving and managing our environment has become crucial. The increasing awareness of the importance of good environmental management systems is evidenced by the amendments made to the Environmental Quality Act 1974 and other environmental regulations which serve to ensure stricter compliance of environmental standards. Malaysia also adopted the National Environment Policy in 2002 as a means of addressing environmental issues in an integrated manner while more and more companies are striving to attain the MS14001 EMS certification.

WHAT SMEs CAN DO TO SAVE THE ENVIRONMENT
As responsible corporate citizens, SMEs have a major role to play in preserving the environment. For starters, they can help the Government to achieve its recycling goals, by creating mechanisms to facilitate the segregation of recyclable wastes and to ensure that these wastes are sent to the relevant parties instead of being dumped in landfills and illegal dumpsites. Furthermore, SMEs must also ensure that proper waste management systems are in place in conducting their day-to-day businesses.

Below are a few steps that SMEs can take to do their part for the environment:
• Dispose off company wastes properly and responsibly.
• Encourage employees to reuse items where possible, for example, printing on both sides of the paper, etc.
• Practise recycling in the office, by introducing a recycling programme. Among the items that can be recycled are papers, cardboards, glass, aluminium cans and scrap metals.
• Implementing an Environmental Management System (EMS).

WHAT IS AN ENVIRONMENTAL MANAGEMENT SYSTEM (EMS)?
An EMS provides a framework for managing environmental practices that integrates with overall business goals in a systematic way. Various models can be applied to develop, implement and maintain an EMS. One of the more common models used by industries is the model described by the ISO 14001 standard which was developed by the International Organisation for Standardisation (ISO). The ISO 14001 standard EMS model focuses on continuous improvement through an on-going cycle of actions called the continual improvement cycle which incorporates the elements of planning, doing, checking and acting.

An EMS typically begins with a strong environmental policy which describes the organisation’s approach in managing its environmental affairs and reflects its commitment to protect the environment and human well-being. The environmental policy establishes the framework for environmental leadership and serves as a contract between an organisation’s employees and its stakeholders. As such, commitment and strong support from top management is essential in making an EMS a success. Developing the environmental policy also helps to lay the groundwork for the planning phase of the EMS cycle. It is in this stage that active management support is sought, a multi-disciplinary EMS implementation team is formed and an introduction meeting is held to brief employees on the implementation of EMS. On top of that, the scope and budget for the implementation of EMS is also pre-defined. In other words, it is important that management provides all the resources necessary for the successful implementation of EMS.

CURRENT ENVIRONMENTAL PRACTICES
It is evident that some SME has put in place various initiatives to preserve the environment while utilizing resources efficiently. These initiatives include the following:

1. Discouraging open burning in fields and plantation sites while encouraging the composting of felled trees and crops in an environmentally-friendly way which in turn prepares land for replanting by using natural fertilizer;
2. Discouraging the use of chlorofluorocarbons (CFCs) in various industrial, commercial and household appliances; and
3. Encouraging the recycling of resources for example, in the plastic manufacturing industry, materials are being regenerated through the forming process in an effort to reuse biodegradable products in an environmentally-friendly way.

WHAT IS WASTE MANAGEMENT?
Waste management involves collecting, transporting, processing, recycling and disposing waste materials, in an effort to reduce their adverse effects on human health and the environment. Waste materials include solid, liquid or gaseous substances. The implementation of waste management requires careful planning and also adequate financial resources and is the responsibility of all parties involved such as individuals, businesses and corporations, including SMEs.

INCENTIVES FOR ENVIRONMENTAL PROTECTION AND WASTE MANAGEMENT
In an effort to support an enhanced level of environmental pro activity, the government provides a range of fiscal activities which includes the Pioneer Status tax exemption and the Investment Tax Allowance for the manufacture of environmentally-friendly products, the provision and supply of environmentally-friendly services and specific activities which contribute towards the presentation of the environment. The said incentives are available for the following activities:

Storage, treatment and disposal of toxic and hazardous waste
Waste recycling activities which are high-tech in nature for instance, recycling agricultural wastes, chemicals and the production of reconstituted wood-based panel boards or other products
Energy-generating activities using biomass which are renewable and environmentally-friendly. Examples of biomass resources include palm oil mill waste, rice mill waste, sugar cane mill waste, timber/sawmill waste and paper recycling mill waste
Energy conservation services

Accelerated Capital Allowance with a special initial rate of 40% and an annual rate of 20% for total write-off within three years is given to organisations that are waste generators, for their capital expenditure on machinery and equipment incurred, to set up facilities to store, treat and dispose their waste. This incentive is also available to companies undertaking waste recycling activities.

The Challenge Of ISO 14001 Standards

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The Challenge Of ISO 14001 Standards

The building blocks of an environmental management system is an understanding of aspects and impacts.

Implementing ISO 14001 begins with identifying how an organisation’s business activities impact on the

environment.

Many organisations believe they are already aware of the significant aspects and impacts of their operations.

The process of implementing ISO 14001 may uncover significant impacts not previously identified and allows

for a consistent approach to analysis.

Generally this analysis is done department by department or centre by centre.

It is best if it is a team approach that involves the employees who do the activity. An employee’s

familiarity with a task is essential for both the identification of the environmental impacts of business

activities and the determination or implementation of control measures.

An aspect is any element of an organisation’s activities, products or services that can interact with the

environment.

An impact is the change caused to the environment.

Impacts may occur during normal and abnormal operating conditions, such as accidents and emergencies.

Aspects can often be isolated by analysing the inputs and outputs of an activity.

EVALUATION OF IMPACTS

Once the impacts have been determined they have to be evaluated.

Criteria for evaluation include environmental concerns such as the severity of the impact, and business

concerns such as potential regulatory and legal exposure, the probability of the impact occurring, the

cost of changing the impact and effect on public image.

This type of evaluation highlights the significant impacts. These, in turn, determine the significant

aspects. Once the significant aspects have been determined, targets and objectives can be set.

What Is ISO 14001 Standards?

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What Is ISO 14001 Standards?

ISO 14001 is primarily concerned with Environmental Management. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

Improving the environmental performance of corporations is one way of limiting environmental damage. Environmental management systems (EMSs), such as ISO 14001, provide a framework for organizations that wish to effectively manage their environmental affairs. Implementing an EMS that conforms to the ISO 14001 standard may help businesses integrate environmental values into their operations.

An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.

The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by the members of the ISO, while others are in different stages of preparation.

ISO 14001 Standards

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ISO 14001 Standards

Monitoring and Measurement In ISO 14001 Standards

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Monitoring and Measurement In ISO 14001 Standards

The Monitoring and Measurement section contains two requirements:

1) Measurement and monitoring of environmental performance associated with operations that can have a significant impact on the environment; and

2) Calibration and maintenance of equipment used for environmental monitoring and measurement.

Monitoring and Measuring of Performance — This section calls for a“procedure to monitor and measure… key characteristics of… operations that can have a significant impact on the environment.”

Note that the section does not specifically require the organization to monitor and measure the significant environmental impacts of its products or services. As a practical matter, however, organizations should establish measurements over all environmental aspects that they determine are significant irrespective of whether the impacts relate to an activity, product, or service.

This section also requires the documentation“of information to monitor performance, applicable operational controls, and… environmental objectives and targets.” §4.6,

Management Review, requires that environmental performance and achievement of objectives and targets become inputs into the Management Review (sub-sections c & d).

Calibration and Maintenance — The requirement of having a calibration system is to ensure that measurements are reliable and accurate. A calibration system may be developed following these steps:

· Identification of measurements to be made;

· Identification of equipment, instruments, hardware and software to be used;

· Identification of the testing methods to be used;

· Determination of the accuracy and precision required or desired;

· Definition of calibration procedures;

· Use of the system;

· Establishment of records;

· If equipment is found to be out of calibration, corrective action; and

· Improvement of the system as necessary.

Evaluation of Compliance In ISO 14001 Standards

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Evaluation of Compliance In ISO 14001 Standards

The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.

Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

INTEGRATING THE NATURAL STEP ELEMENTS INTO ENVIRONMENTAL MANAGEMENT SYSTEMS

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In 1988, Dr. Karl-Henrik Robert began the process of developing the principles and objectives that have become known as The Natural Step.

Robert convened a group of over 100 Swedish scientists and asked them to develop a vision for a sustainable society based on the scientific principles. The Natural Step framework (Robert, 1991) was the result of this effort and is becoming widely recognized.

In this framework, there are four underlying principles or conditions and four guiding objectives.

These system conditions are:

Nature should not be subject to systematically increasing concentrations of substances extracted from the Earth’s crust;

Nature should not be subject to increasing concentrations of substances produced by society;

Nature should not be subject to systematically increasing degradation by physical means; and

People should not be subject to conditions that systematically undermine their capacity to meet their needs.

These conditions can be converted to four objectives that are more easily understood:

Eliminate our community’s contribution to fossil fuel dependency and to the wasteful use of scarce metals and minerals;

Eliminate our community’s contribution to dependency upon persistent chemicals and the wasteful use of synthetic substances;

Eliminate our community’s contribution to encroachment upon nature; and Meet human needs fairly and efficiently.

To apply The Natural Step, Boisvert et al. (1999) recommend an A-B-C-D approach: Awareness, Baseline Analysis, Compelling Vision, and Down to Action. Kent County chose to align its program with The Natural Step because of its simplicity and scientific basis.

An environmental management system (EMS) is a set of processes and practices that enable an organization to reduce the environmental impacts from its operations and increase efficiency. It helps the organization to systematically manage its environmental “footprint.” Alternatively, according to the ISO definition (ISO, 2004) an EMS is “a part of an organization’s management system used to develop and implement its environmental policy and manage its environmental aspects.” It is built upon the concept of continuous improvement and follows a four element Plan-Do-Check-Act cycle. The EMS is an evolving process and is consistently modified to accommodate new information, changing circumstances and changes in organization priorities.

The critical components of each of the four elements are:

Planning, includes identifying environmental aspects and establishing goals [Plan];

Implementing, includes training and operational controls [Do];

Checking, includes monitoring and corrective action [Check]; and

Reviewing, includes progress reviews and acting to make needed changes to the EMS [Act].

There are a variety of reasons that an organization may develop and implement an EMS. The reasons are many and varied and often depend upon the type of organization. A business with international offices has different reasons than a public agency to develop and implement an EMS. Table 1 provides a list of the most common of these reasons.

Some disadvantages to developing and implementing an EMS relate to the costs associated with development of the program and include:

An investment of internal resources, including staff/employee time;

Costs for training of personnel;

Costs associated with hiring consulting assistance, if needed; and

Costs for technical resources to analyze environmental impacts and improvement options, if needed.

Critical factors that assure the success of any management system include:

Commitment from senior management;

Designated staff including a Core team to act as a cheerleader and a representative trained in the program;

Involvement of all employees in the covered fenceline;

Dedicated resources;

A link to the overall strategic planning of the organization;

Sufficient time to develop and implement the program;

Proper follow through on the checking and acting components; and

A willingness to make the cultural shift required for the program to succeed.

The ISO 14001 guidance lists 17 elements, shown in Table 2, as the foundation of an EMS.

Several documents and publications cover the various elements of an EMS in detail. One of these is the US EPA publication “Achieving Environmental Excellence: An Environmental Management Systems (EMS) Handbook for Wastewater Utilities,”

Understand Quality Management

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Quality Management may be defined as the process through which organizations apply statistical process control mechanisms in order to improve the quality and standards of goods and services that are manufactured. Closely related to Quality Management is tqm, also known as total quality management. This is basically a management strategy that is applied in businesses in order to create awareness of high quality in most organizational processes. Quality Management features three main components including quality assurance, quality improvement and quality control. Quality management is focused not only on the quality of products and services but also on continuous improvement of quality standards.
Most methods that are now being used for Quality Management, quality system and quality manufacturing system take into consideration the need for high quality as an essential attribute in services and products that are manufactured by companies and organizations. Quality Management usually involves the successful improvement of quality of services and products. This is usually done through quality training processes where one can also acquire lessons on quality process and process management. One tool that is used for ensuring auditing quality in Quality Management is the MasterControlQAAD(TM) software. Besides using tools to carry out Quality Management successfully, one can also consider applying project management. This will help ensure continuous quality improvement.
The other way through which organizations can improve quality of process and service output is by using six sigma. This is basically a business management strategy that helps identify and remove defects and variations in the manufacturing process. It also helps guarantee Quality Management. It works by using a set of high quality business management and overall management methods to ensure quality and guarantee Quality Management. Most products and services to which Quality Management is applied are certified with iso certificates. Some of the iso certificates that guarantee that a product or service has undertaken Quality Management, change management and process improvement is iso 9001.
iso 9001 and iso 14001:2004 set down specific guidelines for environmental management systems and Quality Management. Other guidelines can be found in other generic process management philosophies such as the lean management that follows iso 9000 quality improvement standards aimed at guaranteeing total quality to its quality systems. The other mode through which organizations guarantee Quality Management is by use of a quality plan that meets iso 14000 and iso 14001 iso certification requirements. The other iso certification that guarantees product quality in Quality Management include iso 9001 2000.
In order to meet supplier quality in Quality Management systems, there are several iso training sessions that are offered. These meet iso standards. An organization that is in need of Quality Management for its products and services may also consider using a quality manual for its day to day Quality Management plans. Such a manual will usually have guidelines for iso quality. However, when applying the guidelines in the manual, regard must be had to quality audit measures aimed at guaranteeing Quality Management for the organization. Quality Management also involves knowledge of as9100 and iso 13485 that are commonly applicable in supplier management.
Quality Management programs that are iso certified help offer quality policy to existing iso 9001 certifications and quality management system that meet iso 9000 and ts16949 requirements. Quality companies that are aimed at ensuring Quality Management for the products and services that they manufacture also use quality management software that guarantees managing quality. In order to enhance Quality Management, the software guarantees quality procedures through its high rate of functionality. Besides such software, an organization can adopt quality assurance training and also offer quality consulting to its members in order to guarantee Quality Management to its products and services.
There are also several quality project management plans, which meet iso standards such as iso 9002 that are available today. Such plans are usually developed with a view to developing flexible, affordable and scalable management solutions to companies that seek to uphold Quality Management for their products and services. Such plans feature quality management systems that offer quality control management and quality assurance management through quality a management plan. Other quality objectives that can be obtained through iso 9001 training thus meeting iso 9000 certification use project management skills to improve Quality Management for the manufactured products and services.

ISO 14001 Standards – Complying with Environmental Laws and Regulations

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One of the most commonly cited reasons for implementing an ISO 14001 environmental management system is that it helps an organization comply with environmental laws and regulations.
ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.
A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.

SUMMARY OF CHANGES TO ISO 14001:2004

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SUMMARY OF CHANGES TO ISO 14001:2004
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed.

Environment Policy In ISO 14001:2004

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Environment Policy In ISO 14001:2004
To develop a successful and effective EMS, five key tasks that must be undertaken by management:a. Select an EMS CoordinatorThe selection of an EMS Coordinator is crucial to the success of your EMS. This person will be responsible for developing and implementing the environmental policy and the EMS. Great care must be taken to ensure that the person chosen is well qualified to handle the responsibilities associated with the EMS.b. Perform a gap analysisA gap analysis determines the differences, or gaps, between one system and another. Not only will this analysis identify the gaps, but it also should etermine the size of the gaps. These findings will lead to recommendations, project plans, and the identification of necessary resources for filling the gaps.
c. Prepare a budget, and obtain the appropriate resourcesAfter conducting a gap analysis, the EMS Coordinator will develop a budget that covers the necessary resources to complete an EMS that conforms with ISO 14001. For some organizations, this may mean establishing a budget for the entire process; other organizations may only need to update certain portions of their existing management system.
ISO 14001 Section 4.4.1 requires top management to provide the essential resources to implement, control, and manage the EMS.
d. Select an EMS TeamTop management and the EMS Coordinator may consider creating an EMS Team to assist in developing and implementing the system. This decision should be based on the size of the organization or facility that will be implementing the EMS.
This team should consist of key individuals from various divisions, departments, and operating work areas within the organization who are familiar with the facility, the various processes, and its environmental requirements. Diversity among team members will bring together a pool of expertise and ideas from which to develop and implement the EMS.
e. Develop an environmental policyThe environmental policy is an essential part of an organization’s EMS. The environmental policy must establish the overall direction of the organization in terms of its commitment to environmental responsibility. A policy should also set the foundation and framework for meeting the environmental objectives and targets for the organization.
The ISO 14001 standard establishes certain requirements that an organization’s environmental policy must meet. If your organization already has an environmental policy, review this section to ensure it meets the ISO 14001 requirements.
The first requirement is that top management must establish and define the environmental policy. Note that ISO 14001 does not specifically state that top management must write the policy, only that it be committed to the policy and ensure its implementation.
These actions are essential in constructing a firm foundation for an effective EMS.

ENVIRONMENTAL and HEALTH & SAFETY COMPLIANCE CHECKLIST

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Self-Audit Procedures
The following checklist should be used as an aid in reviewing your facility’s compliance with industry environmental and health & safety regulations and requirements.
Additional Information: This checklist is based on the current laws and regulations as of the date of publication. Regulations frequently change.
Therefore, you should review current laws and regulations for any recent changes in the requirements. Some of the items you should check include:
Additional Requirements: In addition to recent changes in the requirements, you should also consider additional Cal/OSHA standards that might apply to your facility.
These might include any of the following:
Employer postings; ergonomics; process safety management; use of asbestos, formaldehyde, or lead containing substances; blood borne
pathogens; welding operations; use of compressed air and gases; boiler operations; use of power tools, hoists and grinding equipment; spray coating; elevated platforms; aisle way, ramp, door and exit requirements; fire sprinkler requirements; and seismic requirements.
Legal Authority : The compliance requirements provided on the following pages are taken from the respective laws and regulations, as indicated in the references column. In addition to the statutory and regulatory requirements, some compliance items that reflect improved and accepted management practices have been included. These management practices have been included because of their overall industry acceptance and their potential to reduce environmental risk and improve compliance.

ISO 14001 Standard – Specifications With Guidance for Use

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ISO 14001 Standard – Specifications with Guidance For Use
Given the number of international participants involved in the process of developing the ISO 14001 Specifications, it is amazingly brief, consisting of five pages. This includes a Scope, Definitions, and EMS requirements.
The heart of the specification is in the EMS Requirements, the principles of which are summarized below:
Principle #1 – Commitment and Policy Top management must make a commitment to the program.
Principle #2 – Planning To be successful, the program must be organized. This includes an organizational structure, open communications, both internal and external, and a mechanism for identifying issues.
Principle #3 Implementation Program must be undertaken, including training, writing process descriptions, and establishing prevention programs.
Principle #4 Measurement and Evaluation Create a mechanism for assessing performance and progress toward goals.Principle #5 Review and Improvement? ISO 14004, Section 4, Environmental Management System (EMS)
Reference: ISO 14004, Section 4, Environmental Management System (EMS) Principles and Elements.

ISO 14001 – Certification/Registration

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ISO 14001 – Certification/Registration
Similar to the organized approach to problem solving contained in ISO 9000
and ISO 14000, an organized approach is necessary to achieve certification. Although the written requirements contained in ISO 14001 are straightforward and brief, the level of effort required to conform with the requirements should not be underestimated.
If an environmental review of the facility‘s operations has not been conducted, it is important to retain a qualified consultant to conduct the review. which should focus on the requirements of ISO 14000 versus programs currently in use. This activity is known as a Gap Analysis.?E After the Gap Analysis is completed, the environmental status of the operation should be known and the level of effort necessary to develop the ISO 14000 program understood.
It can easily take six months to a year to develop a program that meets EMS requirements. Staff should develop the EMS program as they will ultimately be required to manage it. If staff is inadequate to develop the program, a consultant can be retained to provide guidance to staff as the program is being developed.
But, retaining a consultant will not resolve the problem of long term program maintenance. The ultimate goal of developing the EMS is to obtain certification/registration. Aside from the internal benefits offered by the ISO 14000 series of standards, external benefits may be derived through the certification/registration process. The certification/registration process only applies to ISO 14001, and this is the only standard to which the audit process applies. For the purposes of certification/registration, all other ISO 14000 standards are considered guidance. Certification can either be by a self declaration?Eor by an independent registrar.
Obviously the use of an independent registrar would give more credibility to those looking at an organization from outside.
Registrars have individual preferences about how the requirements should be administered. A registrar should be selected early in the process to help ensure that the program being developed is consistent with the registrars preferences. When the program is fully prepared and implemented, the registrar will be notified and a formal program audit undertaken. This audit will not result in a denial of ISO 14000 certification, but it may result in either approval or a list of deficiencies that must be corrected before certification.

ISO 14001 ENVIRONMENTAL ASPECTS AND IMPACTS

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ISO 14001 Environmental Aspects And Impacts
The fundamental purpose of the EMS is to control and reduce the environmental impacts of your facility’s processes and products. For this reason, a critical element of the EMS involves identifying and prioritizing the environmental aspects and impacts associated with your facility. An environmental aspect is an element of an organizations activities, products, or services that can interact with the environment. For example, chrome plating is a metal finishing activity and an associated aspect is chrome air emissions.This aspect may have an impact on the environment in several ways, for example, ambient air quality degradation.The environmental aspects and impacts of your metal finishing operations can be identified, prioritized, and documented in several ways. This Template includes two approaches, either of which can be used during EMS implementation. Use the approach that works best for your circumstances. This process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established.
Aspects and Impacts Form A — The first approach uses the experience and judgment ofemployees familiar with facility processes to identify the top five environmental issuescurrently facing the facility. These issues and their specific aspects and impacts shouldbe summarized using Aspects and Impacts Form A.
Aspects and Impacts Form B — The second approach uses detailed, structured matricesto list and prioritize environmental aspects and impacts according to the followingcategories:• Environmental Aspects and Impacts: Wastewater• Environmental Aspects and Impacts: Air Emissions• Environmental Aspects and Impacts: Hazardous and Solid Waste• Environmental Aspects and Impacts: Raw Materials• Environmental Aspects and Impacts: Water and Energy
The matrices that comprise Form B will help facility staff identify and document environmental aspects and impacts. The matrices also provide criteria for prioritizing environmental aspects and impacts; this process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established. One possible way to prioritize environmental aspects and impacts using Form B is described as follows:Step 1:For each aspect and impact, score each prioritization criterion on a scale from 1 to 5, where 1 indicates the criterion is very important or relevant to that aspect (for example, the aspect is strictly regulated, is the subject of compliance violations, or is a waste generated in large uantities), and 5 indicates the criterion is relatively unimportant or irrelevant to that aspect (for example, the aspect is an unregulated waste, is generated infrequently, and is inexpensive to manage).Step 2:Add the scores of all criteria for each aspect and write the total in the right-most column of the form.This number indicates the relative priority of the aspect compared to other aspects and impacts in the same category. The lower the total score, the higher the priority.Purpose Of This procedure is used to identify, document, and update the environmental aspects and impacts of facility processes and operations.
Step 1 The environmental manager and other facility personnel selected by the environmental manager are responsible for identifying and prioritizing the environmental aspects and impacts of facility operations during EMS planning and development.Environmental aspects are characteristics of facility processes and products that interact with the environment. Only environmental aspects the company can control or influence will be considered. Environmental impacts are the effects of an organization’s activitie , products or services on the environment.
Step 2 Environmental aspects and impacts will be documented and prioritized.Environmental aspects and impacts will be associated with the following categories:• Wastewater• Air emissions• Hazardous and solid waste• Raw materials• Water and energyHigh-priority environmental aspects and impacts will be considered when environmentalobjectives and targets are set.
Step 3 The environmental manager and other facility personnel will review and updatethe environmental aspects and impacts documentation annually.
Step 4 Environmental aspects and impacts documentation will be retained at the facilityfor at least 2 years.
Responsible Person: _____________________________________
Signature and Date: ______________________________________

ISO 9001 Standards – Management Review

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ISO 9001 Standards – Management Review
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system

- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs

ISO 14001 ENVIRONMENTAL ASPECTS AND IMPACTS

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ISO 14001 Environmental Aspects And Impacts

The fundamental purpose of the EMS is to control and reduce the environmental impacts of your facility’s processes and products. For this reason, a critical element of the EMS involves identifying and prioritizing the environmental aspects and impacts associated with your facility. An environmental aspect is an element of an organizations activities, products, or services that can interact with the environment. For example, chrome plating is a metal finishing activity and an associated aspect is chrome air emissions.
This aspect may have an impact on the environment in several ways, for example, ambient air quality degradation.
The environmental aspects and impacts of your metal finishing operations can be identified, prioritized, and documented in several ways. This Template includes two approaches, either of which can be used during EMS implementation. Use the approach that works best for your circumstances. This process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established.

Aspects and Impacts Form A -- The first approach uses the experience and judgment of
employees familiar with facility processes to identify the top five environmental issues
currently facing the facility. These issues and their specific aspects and impacts should
be summarized using Aspects and Impacts Form A.

Aspects and Impacts Form B -- The second approach uses detailed, structured matrices
to list and prioritize environmental aspects and impacts according to the following
categories:
• Environmental Aspects and Impacts: Wastewater
• Environmental Aspects and Impacts: Air Emissions
• Environmental Aspects and Impacts: Hazardous and Solid Waste
• Environmental Aspects and Impacts: Raw Materials
• Environmental Aspects and Impacts: Water and Energy

The matrices that comprise Form B will help facility staff identify and document environmental aspects and impacts. The matrices also provide criteria for prioritizing environmental aspects and impacts; this process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established. One possible way to prioritize environmental aspects and impacts using Form B is described as follows:
Step 1:
For each aspect and impact, score each prioritization criterion on a scale from 1 to 5, where 1 indicates the criterion is very important or relevant to that aspect (for example, the aspect is strictly regulated, is the subject of compliance violations, or is a waste generated in large uantities), and 5 indicates the criterion is relatively unimportant or irrelevant to that aspect (for example, the aspect is an unregulated waste, is generated infrequently, and is inexpensive to manage).
Step 2:
Add the scores of all criteria for each aspect and write the total in the right-most column of the form.
This number indicates the relative priority of the aspect compared to other aspects and impacts in the same category. The lower the total score, the higher the priority.
Purpose Of This procedure is used to identify, document, and update the environmental aspects and impacts of facility processes and operations.

Step 1 The environmental manager and other facility personnel selected by the environmental manager are responsible for identifying and prioritizing the environmental aspects and impacts of facility operations during EMS planning and development.
Environmental aspects are characteristics of facility processes and products that interact with the environment. Only environmental aspects the company can control or influence will be considered. Environmental impacts are the effects of an organization's activitie , products or services on the environment.

Step 2 Environmental aspects and impacts will be documented and prioritized.
Environmental aspects and impacts will be associated with the following categories:
• Wastewater
• Air emissions
• Hazardous and solid waste
• Raw materials
• Water and energy
High-priority environmental aspects and impacts will be considered when environmental
objectives and targets are set.

Step 3 The environmental manager and other facility personnel will review and update
the environmental aspects and impacts documentation annually.

Step 4 Environmental aspects and impacts documentation will be retained at the facility
for at least 2 years.

Responsible Person: _____________________________________
Signature and Date: ______________________________________

ISO 14001 ENVIRONMENTAL POLICY

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ISO 14001 ENVIRONMENTAL POLICY

The intent of an environmental policy is to state the organization’s commitment to continuous improvement in environmental performance. A strong, clear environmental policy can serve as both a starting point for developing the EMS and a reference point for maintaining continuous improvement.
The policy should be evaluated regularly and modified, as necessary, to reflect changing environmental priorities.
The policy should function in two ways: (1) within the company, the policy should focus attention on environmental issues associated with company activities, products, and services; and (2) outside the company, the policy is a public commitment to addressing environmental issues and continuously improving environmental performance.
The environmental policy must address:
• Commitment to compliance with relevant environmental legislation and
regulations
• Pollution prevention
• Continuous improvement

Tips for Developing an Environmental Policy:
1. Develop a policy that reflects perspectives of various employees within the company (for example, line worker, owner, wastewater treatment operator, quality inspector, compliance/legal manager, production manager).
2. Display the policy statement in view of all employees; the policy should be available to the public and customers if requested and be printed in languages other than English, as appropriate.
3. Include top management signatures on the policy to demonstrate understanding and commitment.
Purpose This procedure is used to develop and write the company’s environmental policy.

Step 1 The environmental manager will form a policy development team responsible for developing and writing the environmental policy. The policy will address, at a minimum, compliance, pollution prevention, and continuous improvement.

Step 2 The policy development team will review other relevant documents to ensure consistency with other company policies and guide the content and phrasing of the policy. Example documents include the company mission statement and the example environmental policies included in this EMS element.

Step 3 The policy will be displayed in view of all employees and introduced to new employees; the policy will be available in languages other than English, as appropriate, and to the public (on request) and customers (as appropriate).
Step 4 The environmental manager will review the environmental policy at least annually, and update it if needed.

Responsible Person: _____________________________________
Signature and Date: ______________________________________

Environmental Policy Example 1

It is the policy of COMPANY NAME to conduct its operations in a manner that is environmentally responsible and befitting a good corporate neighbor and citizen.
In accordance with this policy, COMPANY NAME complies with all environmental laws and manages all phases of its business in a manner that minimizes the impact of its operations on the environment.
To further this policy, COMPANY NAME shall:
1. Include environmental requirements in planning and design activities
2. Comply with applicable environmental laws and regulations
3. Eliminate, or reduce to the maximum practical extent, the release of contaminants into the environment, first through pollution prevention (material substitution and source reduction), then recycling, and finally through treatment and control technologies
4. Effectively communicate with company employees, suppliers, regulators, and customers, as well as the surrounding community, regarding the environmental impact of company operations
5. Periodically review and demonstrate continuous improvement in the company’s environmental management system

SIGNATURE___________________

Responsible Person
______________________

Environmental Policy Sample 2

Effective Date

ENVIRONMENTAL POLICY

_________________________ IS COMMITTED TO IMPROVE THE HEALTH, SAFETY AND ENVIRONMENT FOR OUR EMPLOYEES, NEIGHBORS, AND FAMILIES.

WE WILL MEET AND OR EXCEED LAWFUL COMPLIANCE THROUGH POLLUTION PREVENTION PRACTICES AND CONTINUOUS IMPROVEMENT.

TO IMPLEMENT THIS POLICY WE WILL CREATE AN ENVIRONMENTAL MANAGEMENT SYSTEM TO IDENTIFY GOALS, SYSTEMS, MEASUREMENTS AND SAMPLING METHODS.
TO SUPPLEMENT THIS POLICY WE WILL INCORPORATE SOURCE REDUCTION THROUGH REUSE, RECYCLING, MATERIAL SUBSTITUTION, NEW AND IMPROVED TECHNOLOGIES, CREATIVE MANAGEMENT AND OPERATIONAL PRACTICES.

TO MAINTAIN THIS POLICY WE WILL PERFORM MANAGEMENT REVIEW, REVENTATIVE MAINTENANCE, EMPLOYEE TRAINING, AND A COMMITMENT AND INVOLVEMENT FROM OUR EMPLOYEES AND MANAGEMENT TO SUPPORT THIS POLICY.

ISO 9001 Standards In General

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ISO 9001 Standards In General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by— its business environment, changes in that environment, or risks associated with that environment,— its varying needs,— its particular objectives,— the products it provides,— the processes it employs,— its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization’s own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

ISO 9001 – Compatibility with other management systems

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ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard

Certification In ISO 9001 Standards

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Certification In ISO 9001 Standards
Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.

Costs and resources Of ISO 9001 Standards

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Costs and resources Of ISO 9001 Standards
The largest cost of ISO 9001 is the involvement of company

employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.

ISO 9000 family of standards and SMEs

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ISO 9000 family of standards and SMEs
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.

Management Principles Of ISO 9001 Standards

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Management Principles Of ISO 9001 Standards
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.

Costs Of Setting Up A Quality Management System

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Costs Of Setting Up A Quality Management System
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.

Benefits Of Obtaining ISO 9000 Certification

2009-09-21T06:16:00.001-07:00

Benefits Of Obtaining ISO 9000 Certification
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.

Implementing A Quality Management System

2009-09-21T06:15:00.000-07:00

Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.

ISO 9001 Standards – Management Review

2009-09-21T06:14:00.000-07:00

ISO 9001 Standards – Design and Development

2009-09-21T06:13:00.000-07:00

ISO 9001 Standards - Design and Development
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

2009-09-21T06:12:00.000-07:00

ISO 9001 Standards - Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us

ISO 14001:2004 Standards Contents

2009-09-21T06:11:00.000-07:00

ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

ISO 9001 Standards New Blogs

2009-09-21T06:10:00.000-07:00

Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System

2009-09-21T06:09:00.000-07:00

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages

ISO 14001 Standards - Contents

2009-09-17T16:08:00.000-07:00

ISO 14001 Standards - Contents
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

Implementing A Quality Management System

2009-09-17T16:06:00.000-07:00

Business benefits of ISO 14000

2009-09-12T07:16:00.002-07:00

Business Benefits Of ISO 14001
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

Requirements for Product Environmental Quality Assurance

2009-09-12T07:16:00.001-07:00

All Mandatory Requirements for Product Environmental Quality Assurance need to be carried out in the following manner1. Establish a system that meets all requirements2. Ensure the system is stable and efficient.3. Document the processes and procedures4. Keep records of the system’s performance.
The assigned management of the supplier shall establish a system to prevent BannedSubstances from being used in the products and packaging.(1) To determine policies and methods for ensuring Product Environment Quality.(2) To assign a person to be in charge of managing Product Environment Quality(“Product Environmental Quality Management Representative”)(3) To establish an organization in managing Product Environment Quality,determine responsibilities, authorities, roles of each department and familiarize allmembers in each department with the importance of Product Environment Quality.(4) To establish a “Cadmium-Free Factory”(5) To review the adequacy and efficiency of the system.
Maintenance of the SystemThe supplier shall maintain the system in a condition to be able to respond to therequests for Product Environment Quality and instruction letters to suppliers),ensure the system is properly functioning.(1) Plan and carry out an internal audit at least once a year.(2) When Non-conforming Products or defects are found in the system, the suppliershall conduct an internal audit immediately.(3) The assigned management for Product Environment Products at the suppliershall revise the system according to the results of the internal audit if necessary.
Documents, Data and RecordsThe supplier should manage documents, verification data related to ProductEnvironment Quality.(1) Keep documents, verification data for three years or longer, if required by law.(2) Provide documents and verification data when requested.(3) Review the documents regularly and keep them updated instructions
Selection of Materials and PartsThe supplier has to comply with the following request when selecting material and parts.(1) “No Use of Banned Substances Allowed” (or equal) must be mentioned in allrelevant documents (specifications, blueprints, purchase orders, etc)(2) Materials must not contain any Banned Substances.(3) Only purchase Designated Raw Materials from Green Partners.

ISO 9000 Standards

2009-09-12T07:12:00.000-07:00

ISO 9000 Standards
ISO 9000 is a written set of rules (a “Standard”) published by an internationalstandards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.ISO 9000 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.Since meeting customer needs is one of the (many) definitions of quality, ISO 9000 is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:
a. Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)
b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objectiveaudit.)
c. Requirements for practices that measure the effectiveness of variousaspects of the system. (In God we trust; all others bring data.)
d. Requirements that support continuous improvement of the company’sability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)
Nothing in ISO 9000 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9000 have been in use in industries of various kinds for decades. One intent of ISO 9000 is to simplify things for organizations. ISO 9000 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9000 is not meant to supersede customer, legal, or regulatory requirements.)
Very often, major customers require or strongly “suggest” that their suppliers implement ISO 9000 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.
So third-party registration bodies audit suppliers, confirm compliance to the ISO 9000 standard, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.
Implementing an ISO 9000 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:
a. The level of commitment of senior management. (The single most important factor.)
b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9000. (But that does not mean you will waltz to registration, either.)
c. Whether your company (or any part of it) is “design responsible” or not.
d. How much time you have. If you are under the customer’s gun and have merely months to get the job done, the process will be highly stressful.
e. The physical size and configuration of your company.
The bottom line is this. ISO 9000 is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9000 as “just another hoop to jump through to keep our customers happy.”
They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9000—expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.

Goal and Scope of an ISO 9000 quality system

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Goal and Scope of an ISO 9000 quality system
The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart ofour organization.b. Continually improving the system. The QMS is never done. Afterall, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving theprocesses of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and theQMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customersatisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.

ISO 9000 registration or certification

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ISO 9000 registration or certification
Registration is documented and objective evidence that an organization’squality system meets the requirements of ISO 9000.
Certification is a term often used interchangeably with registration.
In the context of ISO 9000, they mean the same thing. Registration isthe technically correct term for verification of compliance to standardsof quality systems. Certification usually applies to verification of thequality of products (as opposed to quality systems).
Registration is carried out by independent companies called registrars.These companies are:- Wholly independent.- Accredited by a recognized international accreditation body.- Selected, and paid, by you.
Registration can cover:- The sole location of a single-location organization.- Multiple locations of a multilocation organization.- Only certain parts of a multilocation organization (under certain conditions).- Separate locations under separate certificates. (This is a more costlyapproach.)The registration body audits your quality system against the requirementsof ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances (Question 96). Major noncompliances must be closed out prior to official registration.
When this has been done, the registration body:- Lists the organization’s name in its book of registered companies—in effect, registers the organization in its book.- Issues a certificate to the registered organization. This registrationincludes:— Identity of the organization.— Location(s) covered by the registration.— A list of products/services supplied by the registered locations.— Revision date of the Standard.— Registration effective dates.— Name and location of registrar.
Most registrars limit registrations to three years. After that, youmust renew your registration by undergoing another complete systemsaudit. Some registrars do not use the renewal approach. They simplykeep checking the system via surveillance audits.
Whichever the scheme, the organization, to keep registration, mustundergo a surveillance assessment every so often. Six months is the typicalinterval. Some registrars offer annual surveillance schemes (notrecommended except for firms with exceptionally well-implementedquality management systems). Surveillance assessments are scheduledevents (there is no such thing as a “surprise” surveillance audit). Onlypart of the quality system is checked at each surveillance. Usually, theregistrar does not disclose what part will be assessed until the day of theassessment, although some registrars will tell you everything up front.The entire quality system is usually checked via surveillance audits overthe course of three years.
There is no way to “fail” a surveillance assessment, just as there isno way to “fail” a registration audit—except by refusingto implement corrective action required by the registrar. Normally,registrars allow adequate time, but corrective actions must be done ina timely and agreed upon manner to keep registration.One final note: As mentioned, each registrar publishes a list ofthe firms it has registered to ISO 9000.

What is a quality systems registrar

2009-09-12T07:03:00.000-07:00

What is a quality systems registrar
A registrar, or registration body (the preferred term), is sometimes called a certification body. (Accreditation bodies are entirely different—they are the entities that audit/approve registration bodies.)
There are some 573 registration bodies in operation worldwide, including52 in the United States.
The registrar is the organization that checks your quality system and confirms that it meets ISO 9000 requirements for a prescribed and agreed period of time.
To do this, the registrar:a. Audits your organization’s quality system to determine the degree of conformity to ISO 9000 standards. The audit is carried out:— On paper (desktop study).— On site (throughout your facility).b. Registers your quality system, assuming it conforms, to ISO 9000.c. Monitors conformity on an ongoing basis by means of regular reauditsand other methods.All quality system registrars perform these functions, with certainvariations. Registrars differ in two principal ways:a. Accreditation status.b. Scope of accreditation
Reputable ISO 9000 registrars are accredited by international accreditationbodies. These enforce a standard, EN 45012 (European Standard for Bodies Certificating Suppliers’ Quality Systems), that governs the processes that registrars follow. This standard is quite strict:a. Registrars must make their services available to all qualified supplierswithout imposing undue financial or other conditions, andmust administer their regulations in a nondiscriminatory manner.b. The registrar’s organization must not engage in activities that mayaffect its impartiality. For example:— It must not provide consulting services “on matters to whichits certificates are related” (i.e., quality systems). This requirementis superseded by the ISO 9000 restriction noted earlier.— It must not directly engage in commerce with firms that it hasassessed and/or registered.— Individuals involved in the registration process must not haveprovided consulting services to registration clients, or any relatedfirms, within the previous two years.— Its employees and agents must not engage in business activitiesthat would cause others to question the firm’s impartiality.— The registrar may not market consultancy and registrationservices together, and may not recommend consulting servicesto clients.— Auditors may not give advice as part of registration audits.— The registrar must provide the accreditation body with documentationof its employees’ qualifications.— The registrar must have appropriate facilities for carrying outits activities.— The registrar must have a quality manual and documentedprocedures. (Curiously, EN 45012 does not require that registrarsregister to ISO 9000!)— Registrars may not grant or renew certificates of registration until all major noncompliances are eliminated.
Another point of differentiation is scope of accreditation. All registrarsare not accredited, or approved, to register firms in any line of business. Each registrar is accredited to operate within the business or industrial sectors about which it has documented expertise. This is generically referred to as the registrar’s scope.

How long does it take to register to ISO 9000?

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The time it takes to get ISO 9001 registered are varies. But it is talkingmonths here, not weeks. For one thing, you have to keep running yourbusiness. You cannot simply shut down while getting registered.The entire process can be broken down into the following generalphases:a. Implementing the ISO 9000 system.b. Operating it for the minimum time. (A minimum of three, andpreferably six, months before registration audit.)c. Selecting a registrar. This can be done during the registrationprocess, to save time.d. Interval between application and registration audit. This dependson the registrar’s backlog.
The time it takes to implement the ISO 9000 system depends in largepart on where you are when you start. If you already have any of thefollowing, implementation time should be relatively short:a. A documented quality system of any kind that is active, meaningful,but not necessarily compliant with any particular standard.b. Resources temporarily dedicated solely to implementing the system.c. The guidance of a good consultant
If you are starting from square one, implementation can take a longtime. (Unless you can shut down operations while implementing—butwho can do that?) Here are some other factors that can extend thetime it takes:a. Multiple locations.b. Head count.c. Whether or not you are design responsible.d. Corporate turmoil.e. Lack of ongoing, consistent, persistent top management commitment.This exhibits itself in a host of symptoms, including lack ofsufficient resources, other issues taking priority, vacillation, failureto pay attention, failure to learn and understand, and failureto lead.All that being said, experience has shown the following:a. On average, the shortest interval for the entire process—fromlaunch through registration audit—seems to be around 6 to 9months.b. At the other extreme, it’s been known to take 18 to 24 to 36months, even with significant resources and full managementcommitment.On average, for the typical organization (whatever that is), you arelooking at 10 to 18 months to get the job done.

What does ISO 9000 offer?

2009-09-12T07:01:00.000-07:00

What does ISO 9000 offer? For one thing, it offers you continuedbusiness with customers who may be requiring you to register. That isa pretty strong benefit right there.These customers may never question your quality, but these customersdepend heavily on their main suppliers. They know they canimprove their quality and through-put, if you improve yours. Just because you are great does not mean you are as great as you couldbe. ISO 9000 mandates a continuous improvement system. Youcan wriggle and fudge, but if you implement that system and workit conscientiously, you cannot help but improve. Continuous improvementis not just a buzz term. It is an imperative. Just because you are great today does not mean you will be great tomorrow.Has your industry changed? Has your organizationchanged? A well-implemented ISO 9000 helps your organizationadapt to change. It brings independence of individuals and consistencyof practices—two features that tend to resist declines inperformance.
What else does ISO 9000 bring you? When well implemented, anISO 9000 quality system improves organization performance. That is,after all, the whole point. In cases where it does not, the fault tendsnot to be in the ISO 9000 process (its inherent deficiencies notwithstanding).When an ISO 9000 system does not provide substantial benefits andimprovement in performance, it is usually because managementhas consciously chosen to cut corners, blowsmoke,stay uninvolved, and starve the system of all but the most essentialresources. “We’ll do this stupid thing, but we’re sure not goingto change the way we operate.”ISO 9000 registration brings you one more thing that your organizationmay not have today: International credibility. ISO 9000 is deployedand practiced in nearly 100 countries around the world. Intoday’s ever-growing international economic climate, this is not a bademblem to have, however narrow the scope of your market today.

ISO 9001 – Compatibility with other management systems

2009-09-11T04:54:00.000-07:00

ISO 9001 Standards– Compatibility with other management systems

ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.

During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial
management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for
an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

ISO 9001 standards blog

2009-09-09T22:02:00.000-07:00

Pls visit http://www.iso9001-standard.us for more info.

Five Steps to Implementing ISO 14001:2004

2009-09-08T21:48:00.000-07:00

Five Steps to Implementing ISO 14001:2004

ISO 14001 provides a logical, common-sense approach for

businesses to adopt. To start it is recommended to carry out an

environmental review of the business and the Annex to the Standard

provides guidance on the approach required. The Standard then

requires a management system to be developed that addresses the

key environmental issues that were identified by the review as being

relevant to the business, through a rational programme of control and

continual improvement.

There are five key steps to ISO 14001 EMS implementation, and

subsequent operation which are clearly laid out in just three pages of

text.

The five key steps are:

1. Environmental Policy

2. Planning

3. Implementation and Operation

4. Checking and Corrective Action

5. Management Review

Step 1. Environmental Policy

The company or organisation must write an environmental policy

statement which is relevant to the business activities and approved by

top management. Their full commitment is essential if environmental

management is to work. The ISO 14001 Standard clearly sets out

what to cover in the policy. Often a one page document is sufficient.

Produce a first issue and expect to amend it several times before

assessment and registration as knowledge grows in the company.

Step 2. Planning

Plan what the EMS is to address.

Environmental aspects

First make lists of the environmental aspects (issues) that are relevant

to the business. The environmental review mentioned earlier should

provide most of this information and the Annex to ISO 14001 provides

guidance on the format for doing this.

Consider the inputs, outputs and processes/activities of the business in

relation to;

a) emissions to air

b) releases to water

c) waste management

d) contamination of land

e) use of raw materials and natural resources

f) other local environmental and community issues

Consider both site (direct) and offsite (ie. indirect) aspects that you

control or have influence over (such as suppliers) and in relation to

normal operations, shut-down and start-up conditions and reasonably

foreseeable and emergencies situations.

A simple written procedure is then required to determine which of the

aspects identified are really or probably significant (important) and

training needs, outline the key stages of the project and dates that will

lead to the target achievement).

Gradually apply environmental management programme thinking to

such things as the introduction of new products, new or improved

processes and other key activities of the business. In particular,

ensure existing projects become environmental management projects

where there is a significant environmental impact involved, so that the

EMS becomes company wide. This is a frequent oversight found

during ISO 14001 assessments. The EMS must cover the whole

business – like a net thrown over the whole business and for example

including such things as engineering and maintenance

Step 3. Implementation and Operation

Structure and responsibility

Appoint one or more people, depending on the size of the business, to

have authority and responsibility for implementing and maintaining the

EMS and provide sufficient resources. (It’s worth monitoring costs

carefully and benchmarking these against key consumption figures so

that improvements delivered by the EMS become apparent).

Training, awareness and competence

Implement a procedure to provide environmental training appropriate

to identified needs for management, the general workforce, project

teams and key plant operators. This can have far reaching benefits

on employee motivation. The workforce is usually very supportive of

moves to achieve genuine environmental improvement. Every

company has its share of cynics but even some of these can be won

over with time. Training will vary from a general briefing for the

workforce to detailed environmental auditor training.

Communication

Implement procedures to establish a system of internal and external

communication to receive environmental information and respond to it

and to circulate new information to people that need to know. This will

include: new legislation, information from suppliers, customers and

neighbours and communications both with employees and for

employees about progress with the EMS. This process can often

generate worthwhile ideas from employees themselves for future

environmental improvements.

Environmental management system documentation

The EMS itself needs to be documented with a manual, procedures

and work instructions but keep it brief and simple. The Standard

clearly states where procedures are required. Eleven system

procedures are required to maintain the EMS, plus operating work

instructions but if you already have ISO 9000, this will cover most of six

of the procedures required and a quality system can certainly be

expanded to cover ISO 14001 as well. Cross reference the EMS

manual to other environmental and quality documents to link the EMS

and to integrate it with existing business practices.

Operational control

Implement additional operating procedures (work instructions) to

control the identified significant (important) aspects of production

processes and other activities. Some of these will already exist but

may need a ‘bit of polish’. Don’t forget significant aspects that relate to

goods and services from suppliers and contractors.

Emergency preparedness and response

Implement procedures to address reasonably foreseeable

emergencies and to minimise their impact should they occur. (eg. Fire,

major spillages of hazardous materials, explosion risks etc.)

Step 4. Checking and Corrective Action

Monitoring and measurement

Implement procedures to monitor and measure the progress of

projects against the targets which have been set, the performance of

processes against the written criteria using calibrated equipment (verify

monitoring records) and regularly check (audit) the company’s

compliance with legislation that has been identified as relevant to your

business. The most effective way of doing this is through regular

progress meetings.

Nonconformance and corrective and preventive action

Implement procedures to enable appropriate corrective and

subsequent preventive action to be taken where breaches of the EMS

occur (eg. process control problems, delays in project process, noncompliance

with legislation, incidents etc.).

Records

Implement procedures to keep records generated by the

environmental management system. The Annex to the Standard

suggests those that are likely to be required.

Environmental management system audit

Implement a procedure to carry out audits of each part of the EMS and

company activities and operations to verify both compliance with the

EMS and with ISO 14001. Audit results must be reported to top

management . A typical audit cycle is one year but more critical

activities will require auditing more frequently.

Step 5. Management Review

At regular intervals (typically annual), top management must conduct

through meetings and record minutes of a review of the EMS, to

determine that it is still appropriate and effective or to make changes

where necessary. Top management will need to consider audit

results, project progress, changing circumstances and the requirement

of ISO 14001 for continual improvement, through setting and achieving

further environmental targets.

REQUIREMENTS OF ISO 14001

2009-09-05T19:20:00.000-07:00

REQUIREMENTS OF ISO 14001
In order to effectively implement and benefit from an ISO 14001 EMS, it is important tohave an understanding of the standard’s requirements. A quick review of the standardshows that it is structured following the Plan, Do, Check, Improve philosophy of theTotal Quality Management movement, as follows:
PLAN
4.2 Policy4.3 Planning

DO
4.4 Implementation and Operation

CHECK
4.5 Checking and Corrective Action

IMPROVE
4.6 Management Review
Within these five elements are 17 sub-elements stating the various requirements.
4.2 Policy
4.3 Planning4.3.1 Environmental Aspects
4.3.2 Legal and Other Requirements
4.3.3 Objectives and Targets
4.4.4 Environmental Management Programs
4.4 Implementation and Operation
4.4.1 Structure and Responsibility
4.4.2 Training Awareness and Competence
4.4.3 Communications
4.4.4 EMS Documentation
4.4.5 Document Control
4.4.6 Operation Control
4.4.7 Emergency Planning and Response
4.5 Checking and Corrective Action
4.5.1 Monitoring and Measurement
4.5.2 Nonconformance, Corrective, and Preventive Action
4.5.3 Records
4.5.4 EMS Audit
4.6 Management Review
Within these 17 sub-elements are all of the requirements, or “shalls”, necessary to conform to ISO 14001. There is no substitute for reading the standard in terms of recognizing the requirements. As a matter of fact, no auditor should embark on an audit without having easily available the criteria to which they are doing the audit. However,below we briefly summarize the key points of the sub-elements. This summary is not intended to be a replacement for ISO 14001, and should not be used exclusively as such during an audit.
Detailed Section by Section Summary
4.2 PolicyISO 14001 requires that the organization have a policy statement to drive the EMS.These tend to be short, one page or less documents, and simply affirm the commitments. There is no expectation that specific details be noted in the policy. For example, the commitment to pollution prevention can simply be stated saying, “we are committed to prevention of pollution”. The policy must be clearly endorsed by top management and be available to the public and employees. Although the availability to the public can be rather passive; i.e. “is here if they want it”, there is an expectation that the employee awareness is more proactive. Section 4.2 of ISO 14001 lists the other requirements of the policy.
4.3.1 Environmental AspectsThis element requires a procedure that not only identifies the aspects and impacts, but also provides for determination of significance, and keeping the information up to date.ISO 14001 does not prescribe what aspects should be significant, or even how todetermine significance. However, it is expected the organization will develop aconsistent and verifiable process to do so.
4.3.2 Legal and Other Requirements
This is a requirement for a procedure that explains how the organization obtainsinformation regarding its legal and other requirements, and makes that informationknown to key functions. This is not the assessment or compliance audit requirement, butrather a more up front determination of requirements.
4.3.3 Objectives and Targets
There is no requirement for a procedure in this element, only that objectives and targetsbe documented. It does require that certain items be considered in developing theobjectives, such as legal requirements and prevention of pollution. It is sometimeseasiest to develop a procedure anyway for this element to be able to verify theseconsiderations were made.
4.3.4 Environmental Management Programs (EMP)
EMPs are the detailed plans and programs explaining how the objectives and targets willbe accomplished. These EMPs usually note responsible personnel, milestones and dates,and measurements of success. Noting monitoring and measurement parameters directlyin the EMP facilitates conforming to 4.5.1 on Monitoring and Measurement discussedbelow.
4.4.1 Structure and Responsibility
ISO 14001 requires that the relevant management and accountability structure be definedin this element. This usually takes the form of an organizational chart. Also, theorganization must denote the Management Representative who is responsible to overseethe EMS and report to management on its operation.
4.4.2 Training Awareness and Competence
The key point in this element is that personnel must receive applicable training regardingthe EMS. Specific requirements are itemized in ISO 14001, and include general,company-wide items such as knowing the policy, to more function-specific training onaspects and emergency response. An organization usually responds to this element with atraining matrix, cross-referencing to training materials and records.
4.4.3 Communications
Procedures are required for both internal and external communications. Note that ISO14001 only requires procedures, and allows the organization to decide for itself thedegree of openness and disclosure of information. Whatever the decision in terms ofdisclosure, that decision process must be recorded.
4.4.4 EMS Documentation
This requirement is simply that the organization has documented the system in either electronic or paper form such that it addresses the elements of the standard and providesdirection to related documentation. Not all ISO 14001-required procedures need to bedocumented, as long as the system requirements can be verified.
4.4.5 Document Control.
Procedures are required to control documents, such as system procedures and work instructions, and to ensure that current versions are distributed and obsolete versions areremoved from the system.
4.4.6 Operational Control
This element is the one which connects the EMS with the organization as a whole. Here,the critical functions related to significant aspects and objectives and targets are identified and procedures and work instructions created to ensure proper execution of activities.Requirements for communicating applicable system requirements to contractors are also addressed.
4.4.7 Emergency
Planning and Response Although typically addressed through conventional emergency response plans, thiselement also requires that a process exist for identifying the potential emergencies, inaddition to planning and mitigating them. A linkage to the aspects analysis, where impacts are assessed, is appropriate. Emergency incidents include those that may not be regulated, but may still cause significant impact as defined by the organization.
4.5.1 Monitoring and Measurement
Procedures are required describing how the organization will monitor and measure key parameters of operations. These parameters relate to the significant aspects, objectives and targets and legal and regulatory compliance. In order to properly manage the system, measurements must be taken of its performance to provide data for action. Responses to this element usually cross reference to many other specific procedures and work instructions describing measurement and equipment calibration. It is in this element thatwe find the requirement for what is commonly referred to as a compliance audit.
4.5.2 Nonconformance, Corrective, and Preventive Action
This element requires procedures for acting on Non-conformances identified in the system, including corrective and preventive action. Non-conformances may be identified through audits, monitoring and measurement, and communications. The intent is to correct thesystem flaws. Typically, Corrective Action Report (CAR) forms are the norm, noting the nonconformance, the suggested fix, and closure of the action when completed. Note that this requirement does not imply in any way that the party identifying the nonconformance must be the one to suggest the fix. Instead, it is expected that the system provide for theinformation to be routed to the most appropriate party to address the concern.
4.5.3 Records
Records are expected to exist to serve as verification of the system operating. For example, records include audit reports and training records. Unlike controlleddocuments, records are “once and done” documents, resulting from the execution of some process or procedure. Procedures in this element are required for the maintenance of records.
4.5.4 EMS Audits
ISO 14001 requires that the system provide for internal audits. This procedures(s) will include methodologies, schedules, and processes to conduct the audits. Interestingly, the EMS audit will in essence, audit the audit process itself!
4.6 Management Review
This element requires that periodically, top management will review the EMS to ensure itis operating as planned. If not, resources must be provided for corrective action. For areas where there are no problems, the expectation is that with time, management will provide for improvement programs. Usually there is no detailed procedure for thiselement, although records of agendas, attendance, and agreed upon action items aremaintained as verification.

Business benefits of ISO 14000

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Business Benefits Of ISO 14001

Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

What is a quality systems registrar?

2009-09-05T19:17:00.000-07:00

What is a quality systems registrar?

A registrar, or registration body (the preferred term), is sometimes called a certification body. (Accreditation bodies are entirely different—they are the entities that audit/approve registration bodies.)
There are some 573 registration bodies in operation worldwide, including52 in the United States.
The registrar is the organization that checks your quality system and confirms that it meets ISO 9000 requirements for a prescribed and agreed period of time.
To do this, the registrar:a. Audits your organization’s quality system to determine the degree of conformity to ISO 9000 standards. The audit is carried out:— On paper (desktop study).— On site (throughout your facility).b. Registers your quality system, assuming it conforms, to ISO 9000.c. Monitors conformity on an ongoing basis by means of regular reauditsand other methods.All quality system registrars perform these functions, with certainvariations. Registrars differ in two principal ways:a. Accreditation status.b. Scope of accreditation
Reputable ISO 9000 registrars are accredited by international accreditationbodies. These enforce a standard, EN 45012 (European Standard for Bodies Certificating Suppliers’ Quality Systems), that governs the processes that registrars follow. This standard is quite strict:a. Registrars must make their services available to all qualified supplierswithout imposing undue financial or other conditions, andmust administer their regulations in a nondiscriminatory manner.b. The registrar’s organization must not engage in activities that mayaffect its impartiality. For example:— It must not provide consulting services “on matters to whichits certificates are related” (i.e., quality systems). This requirementis superseded by the ISO 9000 restriction noted earlier.— It must not directly engage in commerce with firms that it hasassessed and/or registered.— Individuals involved in the registration process must not haveprovided consulting services to registration clients, or any relatedfirms, within the previous two years.— Its employees and agents must not engage in business activitiesthat would cause others to question the firm’s impartiality.— The registrar may not market consultancy and registrationservices together, and may not recommend consulting servicesto clients.— Auditors may not give advice as part of registration audits.— The registrar must provide the accreditation body with documentationof its employees’ qualifications.— The registrar must have appropriate facilities for carrying outits activities.— The registrar must have a quality manual and documentedprocedures. (Curiously, EN 45012 does not require that registrarsregister to ISO 9000!)— Registrars may not grant or renew certificates of registration until all major noncompliances are eliminated.
Another point of differentiation is scope of accreditation. All registrarsare not accredited, or approved, to register firms in any line of business. Each registrar is accredited to operate within the business or industrial sectors about which it has documented expertise. This is generically referred to as the registrar’s scope.

ISO 9001 Management Representative

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The ISO 9001 Management Representative is appointed by the top management of an organization. Irrespective of other responsibilities, he/she is responsible and has the authority in
ensuring that processes needed for the quality management system are established, implemented and maintained,
reporting to top management on the performance of the quality management system and any need for improvement, and
ensuring the promotion of awareness of customer requirements throughout the organization.
The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.
The Management Representative is usually assisted at the departmental level by Quality Representatives. This position is assumed by the respective Department Managers. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments.
The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of monitoring processes and identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel within the departments/process areas who are appointed by the Quality Representative to assist him/her at the process-level.
The Management Representative is also assisted by an appointed Document Controller whose responsibility is to implement the Control of Documents and Control of records procedures.
Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is as follows:
Management Representative – Chairman
Document Controller – Secretary
Quality Representatives – Members
[Note: The above is just an example. If you are a small organization, a QMS Committee and Quality Improvement Teams may not be necessary]
To facilitate effecetive communications, the Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is then posted by the Management Representative on the Bulletin Board for the benefit of all employees. Employees are generally encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organization’s premises.
Note: Some organizations employ this method but results may vary among other organizations. The key is to continually improve on these methods/processes.

Introduction to ISO Certification

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Introduction to ISO Certification
Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

ISO 9001 / ISO 14001 Video

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Watch ISO 14001 Video at http://www.youtube.com/watch?v=KUxbyQUGSnU

Watch ISO 9001 Video at http://www.youtube.com/watch?v=G8WI2MgyS7w

Commitment and Environmental Policy

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An environmental policy is a statement of the organization’s overall aims and principles ofaction with respect to the environment, including compliance with all relevant stakeholders. As such, it should be written clearly and concisely to enable a
regulatory requirements. It is a key tool in communicating the environmental priorities of your organization to employees at all levels, as well as to external layperson to understand it, and should be made publicly available. It is up to the organization to decide on environmental priorities based on an initial environmental review, but these choices should be justified in the policy. To be truly effective the policy should regularly be reviewed and revised and incorporated into the organization’s overall corporate policy. The policy statement should set in writing a few achievable quantifiable priorities related to the environmental management system and the significant environmental effects found at the work-site. Furthermore, EMAS requires that the most signifcant environmental effects be mitigated within three years. Some form of improvement must also be accomplished from year-to-year by the organization and must be shown in the annual reports.

Although the formulation of policies and clear priorities is the most important step of
environmental management, this step is often neglected. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Environmental activism?E often containing many isolated activities but no clear direction. For an organization to be a credible and efficient environmental performer and to reap the benefits of being an environmental leader in its markets, the rationale for investing in environmental management must be very clear.

To ensure an organization’s commitment towards a formulated environmental policy, it is
essential that top management is involved in the process of formulating the policy and of setting priorities. Therefore the first step is to get the commitment from the highest level of management. Based on this commitment the organization should then conduct an initial environmental review and draft an environmental policy. This draft should be discussed and approved by the board of directors. Finally, the approved environmental policy statement must be communicated internally and made available to the public.

As the environmental policy establishes an overall sense of direction and sets the principles
of action for an organization, it requires commitment from the highest level of management. Top management should be involved in the development and adoption of an environmental policy.

Getting the commitment from the highest level should be argued on the basis of costs and the implementation of an EMS increases shareholder value it is easier for top
benefits and their impact on shareholder value. If management to commit themselves to approving an environmental policy and to implementing an environmental management system. This commitment includes three basic policy statements:
Continuous improvement in environmental performance
Compliance with environmental regulations

Maintaining public relations regarding environmental issues of the organization, its activities, products and services.

The central focus of the policy should be a commitment to continuous improvement. This

means improvement in the EMS itself and a decrease in environmental impacts caused by an organization’s activities, products and services. It is important for businesses to show improvement over time, both in environmental performance and in organizational commitment to this path.

A commitment to comply with at least local environmental regulations is a minimum
requirement for all of the environmental standards. However, multinationals operating in various environments and facing different laws in each, should think about which laws to abide by and if it is feasible to adopt the same standard worldwide. Generally, laws in newly industrializing countries are lax as compared to industrialized countries. However, given the increase in interest in environmental issues in these industrializing countries and the possible impact of the ISO 14000 series, it may be sound practice to adopt the more stringent laws in worldwide operations, where it is feasible to do so. In addition, the adoption of high standards worldwide can yield other benefits, such as an improved public image or easier technology transfer between different sites.

Companies should guard against going overboard in fulfilling environmental policies. Limits
are in fact set on how far a company has to go to reduce its environmental impacts. Reductions do not have to exceed levels which can be achieved by economically viable application of the best available technology (BAT).
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The Development of EMS Standards
Posted by everise iso 14001 Sunday 23 August 2009 1:41 am
The world’s first standard for environmental management systems (EMS) – BS 7750 – wasdeveloped and published by the British Standards Institution (BSI) in 1992. This standard was the model for the ISO 14000 Series developed by the International Organization for Standardization (ISO). ISO 14001, which establishes the requirements for an EMS, was finalized in 1996. BS 7750 was also the basis for the European Union’s Eco-Management and Audit scheme, known as EMAS.
ISO is an international standard and therefore must incorporate the different interests ofmany countries. This standard clearly has the weakest requirements. By contrast, EMAS is the most stringent and detailed standard reflecting the high environmental standards of German interests and companies which played a key role developing it.
Because ISO 14001 and EMAS are both based on BS 7750, all three standards arequite similar in their approach. If your organization complies with BS 7750 today, little effort will be needed to fullfill the requirements of ISO 14001 or EMAS. Be aware however, that EMAS emphasizes public environmental reporting.
Today there are two major areas in the evaluation of environmental management practice.One area focuses on organizational issues, and the other on products, services and processes.

1. Organization Evaluation
a. Environmental Management Systems (ISO 14001, 14004)
b. Environmental Performance Evaluation (ISO 14014, 14015, 14031)
c. Environmental Auditing (ISO 14010, 14011, 14012, 14013, 14014)

2. Products, Services and Processes

a. Life Cycle Assessment (ISO 14040, 14041, 14042, 14043)

b. Environmental Labeling (ISO 14020, 14021, 14022, 14023, 1402X)

c. Environmental Aspects in Product Standards (ISO 14060)
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ISO 14000 – Environmental Program Management
Posted by everise iso 14001 Friday 21 August 2009 11:07 pm
The ISO 14000 series of standards has
received widespread attention, and, like ISO 9000, it is becoming a requirementfor domestic and global organizations.
This document is intended to provide a
baseline understanding of the ISO 14000 standards and to discuss the current status of this important standard.
The International Organization for Geneva, Switzerland, is composed of 92 European Union (EU) to establish universal quality standards. Over time, ISO
Standardization (IOS), headquartered in member countries. Adherance to standards developed by the IOS is voluntary. However, countries and industries may adopt the IOS standards. Until approximately 15 years ago, IOS focused on traditional standards-setting activities. In 1987, IOS published the ISO 9000 series standards that were used with the 9000 became recognized as a positive indicator of quality and a prerequisite to establishing/maintaining business relationships within and outside the European Union.
In the United States, both the American
National Standards Institute and the American Society of Quality Control are privately funded organizations that have adopted ISO 9000, Quality Management, and the ISO 14000 standards.
ISO 14000 is the generic title given to 14040, ISO 14041, and ISO14050 have
the 14000 series of standards. ISO 14001, ISO 14004, ISO 14010, ISO 14011, ISO 14012, ISO 14020, ISO been published as international standards. The ISO 14000 series of standards consists of the following 18 subjects that can be grouped under two major headings:
14001 Specification with Guidance for Use
14004 General Guidelines on Principles,
14010 General Principles of Environmental Auditing
14011 Audit Procedures
14012 Environmental Auditing ? Qualification Criteria
14015 Environmental Site Assessments
14031 Evaluation of Environmental Performance ? Guidelines
14032 Evaluation of Environmental Performance ? Case Studies
14020 Goals and Principles of All Environmental Labeling
14021 Environmental Labels and Declarations ? Terms and Definitions
14024 Environmental Labels and
14025 Type III Labeling
14040 Life Cycle Assessment ? Principles and Framework
14041 Life Cycle Assessment ? Inventory Analysis
14042 Life Cycle Assessment ? ImpactAssessment
14043 Life Cycle Assessment ? Interpretation
14048 Life Cycle Indicator Format
14050 Guide on the Principles of Terminology Work

At the current time, the ISO 14000 as International Standards are referred to
Standards that have not been published as Draft International Standards (DIS). Most DIS are in the final review period before publication. If a particular standard is of interest and is not final, a copy of the DIS may be available for review.

Measurement and Evaluation In ISO 14001:2004

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After implementing the environmental policy, management needs to measure environmental that the data can be verified by an internal or external auditor.
interventions and their impact on the environment. This is done by building up an environmental effects register (environmental inventory). All equipment used for monitoring and measuring must be accurate and calibrated on a regular basis. To check the compliance status of an organization, additional information about regulations and other requirements is needed. A so called environmental regulations register?Eis often installed and maintained for this purpose. To obtain a better picture about the financial consequences of environmental protection, the accounting system should reflect environmental costs. Therefore, information about environmentally-induced costs and earnings needs to be collected. All this information should be recorded in such a manner.er
Environmental Performance Evaluation Accesses Environment Performance against environmental targets and objectives and against applicable environmental regulations. Responsibilities and authority need to be defined to deal with non-compliance within the EMS. This includes specifying the actions to be taken to correct an undesirable ituation and to prevent future non-compliance.
The analysis of environmental and economic performance leads to eco efficiency, the key component in sustainable business management.
The analysis of environmental and economic performance leads to eco
efficiency, the key component in sustainable business management. The recording of physical environmental data, environmental regulations and environmentally-induced financial information is necessary as a basis for effective decision making. Therefore, financial, legal and ecological data systems must be built up from scratch or adapted to the requirements of the EMS standard.

Key Elements of ISO 14001

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Key Elements Of ISO 14001
The Resources, Roles, Responsibility, and Authority; Legal and Other Requirements; Evaluation of Compliance; and Nonconformity, Corrective Action and Preventive Action elements of ISO 14001 are all essential to the ongoing effectiveness of the EMS. This section describes how they function within the overall scheme.
1. Resources, Roles, Responsibility, and Authority (ISO 14001:2004, ?4.4.1)
?4.4.1 of ISO 14001 establishes three important requirements:
1. That management ensure the availability of resources to establish, implement, maintain, and improve the EMS;
2. That roles, responsibilities, and authorities be defined, documented, and communicated in order to facilitate effective environmental management; and
3. That top management appoint a management representative(s) who, irrespective of other responsibilities, will have responsibility and authority for implementing and maintaining the EMS and for reporting to top management on the performance of the EMS.
Ensuring Availability of Resources – Provision of resources for the EMS is almost always an issue within organizations. Although top management usually understands and accepts, at least in principle, the requirement to provide resources, the level of management that makes decisions on capital deployment and operating budgets often does not subscribe to the same requirement. Making the case for resources typically requires the implementation team or management representative to quantify intangibles such as the avoided cost of regulatory fines or the value to the environment of reducing environmental impacts.
When considering the requirement to provide resources, especially financial resources, it may be important to recognize that ISO 14001 requires the provision of resources for the establishment, implementation, maintenance, and improvement of the EMS, not necessarily resources to correct or prevent environmental impacts or to register to ISO 14001. When contemplating the cost of implementing ISO 14001, organizations, again, should think in terms of three separate cost categories:
1) Internal labor and external consultant costs to establish, implement, maintain, and improve the policy and procedural elements of ISO 14001;
2) Capital costs for correction or prevention of environmental impacts; and
3) Costs of registration to ISO 14001, if the organization elects to register.
Roles, Responsibilities, and Authorities – In the past, some organizations have employed a practice of not delegating responsibility and authority for environmental affairs to specific management representatives, reasoning that if the responsibility was diffused throughout the organization, no one person could become personally accountable for non-compliance with regulations or for environmental liabilities. §4.4.1 of ISO 14001 limits such ‘willful ignorance’ by requiring top management of the organization to appoint “specific management representative(s)” to ensure that the EMS is implemented and that top management be apprised of EMS performance. It also requires that the delegation of responsibility and authority be documented and communicated, thus eliminating circumstances where responsibility and authority for the EMS are diffuse or uncertain.
When §4.4.1 is read together with the requirement of the Environmental Policy for a commitment to comply with applicable legal requirements, §4.3.2, Legal and Other
Requirements, requiring a procedure for identifying legal requirements (following), and §4.5.2, Evaluation of Compliance, requiring a procedure for evaluating regulatory compliance, it is evident that the management representative is also responsible for ensuring that the organization is in compliance with applicable regulations. While this responsibility and authority can be delegated, the chain of delegation begins with top management and is passed to the management representative, effectively eliminating any uncertainty as to who is responsible and authorized to ensure regulatory compliance.
EMS Organizational Structure – There is an almost universal norm for the management structure of the EMS organization under ISO 14001. It begins with the top management position, proceeds to the top manager’s leadership team, and then to an EMS implementation team that is generally chaired by the management representative. The departments making up the relevant functions and levels of the organization and environmental, safety, and health professionals comprise the typical implementation team.
Defining Roles, Responsibilities, and Authorities for the EMS – In defining, documenting, and communicating EMS roles, responsibilities, and authorities, it makes sense to begin with top management and proceed through all of the positions having EMS responsibilities. Following is a generic example of how roles, responsibilities, and authorities might be documented and communicated in an EMS Procedures Manual:
Plant Manager
Authority: The Plant Manager has the authority, responsibility, and accountability for managing all aspects of ABC Company’s activities, products, and services at the Anytown facility.Source: Senior Vice President, Manufacturing, ABC Company, Inc.
EMS Responsibilities: Under the requirements of ISO 14001, the Plant Manager shall be specifically responsible for:
1) Defining the Environmental Policy;
2) Delegating authority and responsibility for the establishment, implementation, maintenance, and improvement of the EMS;
3) Providing human, technological, infrastructure, and financial resources and specialized skills; and
4) Periodically reviewing the EMS for suitability, adequacy, and effectiveness and directing changes as necessary to achieve the goals for an EMS and the commitment to continual improvement.
Leadership Team
EMS Responsibilities: The Leadership Team shall advise the Plant Manager on the exercise by
the Plant Manager of his/her responsibilities for the EMS.
Management Representative, Implementation and Maintenance Responsibilities
EMS Authority: The Plant Manager delegates to the Manager, the authority
to establish, implement, maintain, and improve the Environmental Management System and to
ensure that it conforms to the requirements of ISO 14001. In the context of ISO 14001, the
Manager, shall be the Management Representative.

Document and Data Control in ISO 9000 & ISO 14001

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The organization shall establish and maintain procedures for controlling all documents and data required by ISO 9000 & ISO 14001
a) they can be located;
b) they are periodically reviewed, revised as necessary, and approved for adequacy by authorized personnel;
c) current versions of relevant documents and data are available at all locations where operations essential to the effective functioning of the OH&S system are performed;
d) obsolete documents and data are promptly removed from all points of issue and points of use, or otherwise assured against unintended use;
e) archival documents and data retained for legal or knowledge preservation purposes, are suitably identified.
Accidents, incidents, non-conformances and corrective and preventive action
The organization shall implement and record any changes in the documented procedures resulting from corrective and preventive action.
Documents required by the ISO 9000 & ISO 14001 shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements.
The organization shall establish, implement and maintain procedure[s] to:
a) approve documents for adequacy prior to use;
b) review and update as necessary and re-approve documents;
c) ensure that changes and the current revisions status of documents are identified;
d.) ensure that relevant versions of applicable documents are available at points of use;
e.) ensure that documents remain legible and readily identifiable;
f.) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the ISO 9000 & ISO 14001 management system are identified and their distribution controlled, and
g.) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose.

The Future of ISO 14001

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ISO 14001 has the potential to reframe the conduct of environmental management. It has proven to be an elegant document that anticipates the needs of organizations of all sizes and purposes for direction on environmental management.
As ISO 14001 gains credibility as an effective system for managing and improving environmental performance, environmental regulators will be encouraged to accept registration to ISO 14001 in satisfaction of some regulatory administrative requirements and, thus, reduce the burden of compliance for those organizations that are managing their environmental exposures.
Ultimately, the greatest strides in environmental performance improvement and sustainability will come as a consequence of millions of organizations – municipalities, colleges and universities, governmental departments, and property owners and operators as well as industrial corporations – identifying and managing the environmental impacts of their activities, services, and products.

Assessing the Corporate Impact of ISO 14000 Certification

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The 1990s have indeed been a period of change. This has seen a change from a perspective that longer viewed as something that is primarily done for publicity sake or to avoid prosecution. Rather it is recent emergence of the ISO 14000 environmental standard.

There are several features that make this emphasized trade-offs (you can have only one of the following ? shorter lead times, lower costs or higher quality) to a paradigm that stresses simultaneity (you can simultaneously achieve lower costs and higher quality and shorter lead times). This has also become a period when more and more managers are expected to become increasingly environmentally conscious. Being environmentally responsible is no seen as a matter of good business. An indication of the increasing importance of the environment is the new standard noteworthy.

First, it builds on the success of ISO 9000, and its variants (e.g., QS 9000).
Second, ISO 14000 is an international standard. It is hoped that it will replace the numerous and often conflicting standards found in various countries.
Third, ISO 14000 shifts attention from the outcome (reduced pollution) to processes.

However, being a new standard, the introduction of ISO 14000 has raised a number of questions.

Environmental Aspects (ISO 14001:2004, 4.3.1)

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The requirement of ?4.3.1 of ISO 14001 is to establish and maintain procedures 1) for identifying the environmental aspects of the organization’s activities, products, and services that it can control and those that it can influence and 2) for determining which of those aspects have or can have a significant impact on the environment. Understanding the requirement of this element of ISO 14001 is central to understanding the concept of an environmental management system.
1 .A single manufacturing facility has potentially hundreds of environmental aspects. How far must it go in identifying its environmental aspects to satisfy the terms of the requirement? ISO 14001 specifies that the organization is to identify those aspects that it can control and those that it can influence and that it must also take into account planned or new developments and new or modified activities, products, and services. These stipulations in the requirements, without actually drawing boundaries on how far the organization must go in identifying environmental aspects, at least establish some categories of aspect that must be considered. Beyond this principle, each organization must identify its aspects comprehensively enough so as to not fail to identify a significant aspect or a legal requirement. An objection to comprehensive identification of aspects is that the organization may become so immersed in aspects identification that it loses sight of the end objective of the procedure, which is to determine significance.
2. Significant impact is not a stand-alone term in ?4.3.1.
It is accompanied by the phrase impact on the environment_ and environment_ is a defined term (see definition of environment, ?3.5). Significant aspects, then, are those environmental aspects that have or can have significant impacts on air, water, land, natural resources, flora, fauna, and humans. The organization determines, using its own criteria, what magnitude of impact on these seven environmental receptors constitutes a significant impact. Whether an aspect is regulated is not intended to be a factor in determining significance.
3. Proper execution of the environmental aspects procedure is important, in part, because it lifts environmental management out of the regulatory compliance mode and into the mode of systematically identifying environmental aspects and impacts and considering their consequences for the environment, irrespective of regulation. The organization that rigorously applies the environmental aspects procedure discovers many opportunities to improve environmental performance that regulation does not address, including:
• Use of energy
• Consumption of materials
• Environmental impacts of employee activities
•Environmental impacts of products and by-products post-manufacture, including distribution, use, reuse, and disposal
• Environmental impacts of services
• Unregulated waste streams such as carbon dioxide
Aspects vs. Impacts – Environmental aspects and environmental impacts differ by definition from one another in that an aspect is an element of an organization’s activities, products or services that can interact (emphasis added) with the environment_ while an impact is any change (emphasis added) to the environment_ resulting from an organization’s environmental aspects._ An aspect, then, is a precursor to an impact and an impact occurs when the aspect interacts with and changes the environment.
When identifying its aspects and impacts, the organization may find that there are more than one potential impacts associated with any given aspect. For example, an environmental aspect of a coal-fired power generation facility is stack emissions containing sulfur dioxide, nitrogen oxides, mercury, and carbon. These emissions change the environment and become impacts by contaminating plants, soil, and surface waters; contributing to the formation of ground-level ozone; causing or exacerbating heart and lung disease in humans; entering the aquatic food chain and impairing reproductive, immune, and endocrine systems; and contributing to the increase in atmospheric carbon dioxide leading to global warming. One aspect, stack emissions, then can generate at least five impacts.
Other organizations, applying benefit/cost analyses to their corrective actions, may discover that creation of a beneficial impact provides a greater environmental benefit than elimination of an adverse impact.
The introduction of the beneficial environmental impact concept into the ISO 14001 Terms and Definitions suggests that it was considered by some of the ISO 14001:1996 drafters as a placeholder for the future possibility of offsetting adverse impacts with beneficial and, on balance, achieving an environmentally neutral organization.
Control and Influence – The environmental aspects procedure requires the organization to identify those environmental aspects that it can control and those that it can influence._ Circumstances where control and influence are considered separately can occur where the environmental aspects of products or services are concerned. Some examples illustrate the case:
1. No control, no influence – When an organization manufactures a product, such as lumber, and sells it to a customer that can use the product in any way that it wishes, the organization has no control over the environmental aspects of the product’s use. The customer could use the product benignly as in the manufacture of a table or to damage the environment by burning the lumber and releasing its carbon into the atmosphere. In this case, the organization would not be expected to have either control or influence over the environmental aspects of the product.
2. Control, no influence – When an organization’s environmental aspect is the use of electric power generated from coal, it may be able to control its use of electric power by using less, by buying from a different, less environmentally damaging source, or by generating its own power. Rarely, however, does the organization have influence over the power generator to an extent that it could influence it to reduce the environmental impacts of power production.
3. Influence, no control – When an organization manufactures a product, such as an automobile, which is sold to the customer without restrictions on its use, the organization may be said to have no control over the environmental aspects of the product’s use. The organization may, however, be able to assert influence with the inclusion of owner’s manuals containing instructions for low impact use of the product.
4. Control and influence – When an organization buys a product built to its specifications, it has control over the products’ environmental aspects in the sense that it can determine the environmental aspects of the product. In this case, control also includes influence.
Significant Impacts – ISO 14001 does not provide guidance as to what constitutes a significant impact on the environment_, leaving that determination to the organization.
Many organizations ignore the qualifying phrase, impact on the environment_, and add additional criteria to what they determine to be significant impacts. For example, many organizations decide that aspects that are the subject of regulation, irrespective of impact to the environment, or that can cause damage to business reputation, are significant. Legal requirements, however, are identified in ?4.3.2 and legal requirements and business requirements are specifically considered when the organization establishes its objectives and targets (?4.3.3). Adding criteria that are not relevant to impact on the environment in the determination of significance distorts the outcome of procedures for environmental aspects and objectives and targets by giving these criteria undue weight in the determination of significance. For example, an environmental aspect that is significant only because its disclosure might affect the organization’s reputation is best dealt with in the Public Relations Department rather than as an environmental aspect.
Determination of significance is a yes or no question, not a determination of relative value. It is possible, therefore, that the execution of the environmental aspects procedure will result in the determination that the organization has no significant aspects. While the organization may elect to rank its aspects from most significant to least significant, that does not necessarily mean that any rise to the level of significant impact on the environment.
Where the impact occurs can be material to determination of significance. For example, a coal-fired power plant’s air emissions can interact with the environment; these emissions are clearly environmental aspects. Whether they significantly impact the environment may depend upon where the interaction with the environment occurs.
Part of the importance of establishing significance lies in the fact that the potentially significant environmental impacts become a focus of Objectives and Targets (?4.3.3), Competence (?4.4.2), Operational Controls (?4.4.6), and Monitoring and Measurement (?4.5.1) requirements.
An organization that determines that aspects are significant because of regulation or business reputation increases the amount of work it must do in these areas.
ISO 14001 does not require the organization to establish objectives and targets for each significant environmental aspect. On the one hand, the absence of a requirement to set objectives and targets for all significant aspects gives organizations latitude to conform to the requirements of ISO 14001 while not presently dealing, for example, with the significant environmental aspects of products. On the other, a requirement to establish objectives and targets for all identified significant aspects could easily overwhelm an organization having many significant aspects. Without this latitude, organizations might choose to ignore the existence of significant aspects that they believe are insurmountable or even decide not to implement ISO 14001. As it is, many organizations choose to deny the existence of significant aspects about which they feel they can do nothing.

Key Elements of ISO 14001

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The Resources, Roles, Responsibility, and Authority; Legal and Other Requirements; Evaluation of Compliance; and Nonconformity, Corrective Action and Preventive Action elements of ISO 14001 are all essential to the ongoing effectiveness of the EMS. This section describes how they function within the overall scheme.
1. Resources, Roles, Responsibility, and Authority (ISO 14001:2004, ?4.4.1)
?4.4.1 of ISO 14001 establishes three important requirements:
1. That management ensure the availability of resources to establish, implement, maintain, and improve the EMS;
2. That roles, responsibilities, and authorities be defined, documented, and communicated in order to facilitate effective environmental management; and
3. That top management appoint a management representative(s) who, irrespective of other responsibilities, will have responsibility and authority for implementing and maintaining the EMS and for reporting to top management on the performance of the EMS.
Ensuring Availability of Resources – Provision of resources for the EMS is almost always an issue within organizations. Although top management usually understands and accepts, at least in principle, the requirement to provide resources, the level of management that makes decisions on capital deployment and operating budgets often does not subscribe to the same requirement. Making the case for resources typically requires the implementation team or management representative to quantify intangibles such as the avoided cost of regulatory fines or the value to the environment of reducing environmental impacts.
When considering the requirement to provide resources, especially financial resources, it may be important to recognize that ISO 14001 requires the provision of resources for the establishment, implementation, maintenance, and improvement of the EMS, not necessarily resources to correct or prevent environmental impacts or to register to ISO 14001. When contemplating the cost of implementing ISO 14001, organizations, again, should think in terms of three separate cost categories:
1) Internal labor and external consultant costs to establish, implement, maintain, and improve the policy and procedural elements of ISO 14001;
2) Capital costs for correction or prevention of environmental impacts; and
3) Costs of registration to ISO 14001, if the organization elects to register.
Roles, Responsibilities, and Authorities – In the past, some organizations have employed a practice of not delegating responsibility and authority for environmental affairs to specific management representatives, reasoning that if the responsibility was diffused throughout the organization, no one person could become personally accountable for non-compliance with regulations or for environmental liabilities. §4.4.1 of ISO 14001 limits such ‘willful ignorance’ by requiring top management of the organization to appoint “specific management representative(s)” to ensure that the EMS is implemented and that top management be apprised of EMS performance. It also requires that the delegation of responsibility and authority be documented and communicated, thus eliminating circumstances where responsibility and authority for the EMS are diffuse or uncertain.
When §4.4.1 is read together with the requirement of the Environmental Policy for a commitment to comply with applicable legal requirements, §4.3.2, Legal and Other
Requirements, requiring a procedure for identifying legal requirements (following), and §4.5.2, Evaluation of Compliance, requiring a procedure for evaluating regulatory compliance, it is evident that the management representative is also responsible for ensuring that the organization is in compliance with applicable regulations. While this responsibility and authority can be delegated, the chain of delegation begins with top management and is passed to the management representative, effectively eliminating any uncertainty as to who is responsible and authorized to ensure regulatory compliance.
EMS Organizational Structure – There is an almost universal norm for the management structure of the EMS organization under ISO 14001. It begins with the top management position, proceeds to the top manager’s leadership team, and then to an EMS implementation team that is generally chaired by the management representative. The departments making up the relevant functions and levels of the organization and environmental, safety, and health professionals comprise the typical implementation team.
Defining Roles, Responsibilities, and Authorities for the EMS – In defining, documenting, and communicating EMS roles, responsibilities, and authorities, it makes sense to begin with top management and proceed through all of the positions having EMS responsibilities. Following is a generic example of how roles, responsibilities, and authorities might be documented and communicated in an EMS Procedures Manual:
Plant Manager
Authority: The Plant Manager has the authority, responsibility, and accountability for managing all aspects of ABC Company’s activities, products, and services at the Anytown facility.Source: Senior Vice President, Manufacturing, ABC Company, Inc.
EMS Responsibilities: Under the requirements of ISO 14001, the Plant Manager shall be specifically responsible for:
1) Defining the Environmental Policy;
2) Delegating authority and responsibility for the establishment, implementation, maintenance, and improvement of the EMS;
3) Providing human, technological, infrastructure, and financial resources and specialized skills; and
4) Periodically reviewing the EMS for suitability, adequacy, and effectiveness and directing changes as necessary to achieve the goals for an EMS and the commitment to continual improvement.
Leadership Team
EMS Responsibilities: The Leadership Team shall advise the Plant Manager on the exercise by
the Plant Manager of his/her responsibilities for the EMS.
Management Representative, Implementation and Maintenance Responsibilities
EMS Authority: The Plant Manager delegates to the Manager, ______ _______, the authority
to establish, implement, maintain, and improve the Environmental Management System and to
ensure that it conforms to the requirements of ISO 14001. In the context of ISO 14001, the
Manager, _____ _________, shall be the Management Representative.