Management Review IN ISO 9001 Standard

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

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

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

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.

Changes in ISO 9001:2008 Quality Standard

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

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

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