Improve your performance management with new version of ISO 9001

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

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

ISO 9001 Standards & ISO 14001 Standards

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?

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.

ESTABLISHING THE INITIAL STATE OF THE QUALITY MANAGEMENT SYSTEM

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.

Introduction to ISO Certification

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

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

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