The 1990s have indeed been a period of change. This has seen a change from a perspective that
emphasized trade-offs (you can have only one of the following 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 longer viewed as something that is
primarily done for publicity sake or to avoid prosecution. Rather it is seen as a matter of good business.
An indication of the increasing importance of the environment is the recent emergence of the ISO
14000 environmental standard. There are several features that make this 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, namely:
1. What is the status of environmental management systems in most American plants and how are they perceived by management?
2. How are the predispositions of management towards ISO 14000 influenced by factors such as pastexperience with ISO 9000, corporate orientation towards environmental responsibility, industrial factors, importance of international trade to corporate performance and the functional positions of the respondents?
3. To what extent do the respondents see a relationship between ISO 14000 registration and success and improved market, or corporate performance?
4. How effective is ISO 14000 relative to the other alternatives available for improving environmental performance?
These and other questions formed the focus of a recently completed two-stage study into the status of ISO 14000 certification in the United States. The first phase consisted of a large-scale survey (consisting of some 16 pages) that were sent out to managers in various functions across the United States. This phase generated a database of 1,510 respondents. In the second phase, the researchers examined detailed case studies of eight plants shorter lead times, lower costs or higher? experience with ISO 14000. These plants were drawn from five categories:
ISO 14000 not being consider/only do it if mandated;
Assessing suitability of ISO 14000;
Planning for ISO 14000/Pursuing ISO 14000 Certification;
Implementing ISO 14000/Pilot Plants in North America; and,
Successfully certified in ISO 14000.
Implications for the Purchasing Professional
To date, the purchasing professions have played a relatively minor role in the ISO 14000-certification process. For the most part, interest in certification has been confined to within the firm. However, this
certification process can and does present the purchasing professional with certain opportunities to improve both environmental and strategic performance not only within the firm but also within the supply
chain. The results point out the need for purchasing professionals to take a more active role within the ISO 14000-certification process. They must start looking for and exploiting previously overlooked opportunities.
ISO 14000-certification represents a growth in opportunities.
In short, this study shows that there is much more action than hype about the ISO 14000 environmental standards. The early results are in and the evidence, while not complete, indicates that ISO 14000-certification does work. It does achieve the twin objectives of reduced pollution and improved corporate performance.
Monday, August 10, 2009
Version Of ISO 9001 Standard
1987 version
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three ‘models’ for quality management systems, the selection of which was based on the scope of activities of the organization:
ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987
1994 version
was also influenced by existing U.S. and other Defense Standards (”MIL SPECS”), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.ISO 9000:19942000 version
emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.ISO 9001:2000
The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.2008 version
ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements. Explanation of changes in ISO 9001:2008. A Practical Guide to ISO 9001:2008 Implementation A quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.
combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center (”Process management” was the monitoring and optimizing of a company’s tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.
ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three ‘models’ for quality management systems, the selection of which was based on the scope of activities of the organization:
ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987
1994 version
was also influenced by existing U.S. and other Defense Standards (”MIL SPECS”), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.ISO 9000:19942000 version
emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.ISO 9001:2000
The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.2008 version
ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There are no new requirements. Explanation of changes in ISO 9001:2008. A Practical Guide to ISO 9001:2008 Implementation A quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.
combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center (”Process management” was the monitoring and optimizing of a company’s tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.
ISO 9000 — a way of managing for conformance
Quality assurance, according to the Standard, is a way of managing that prevents non-conformance and thus “assures quality”. This is what makes ISO 9000 different from other standards: it is a management standard, not a product standard. It goes beyond product standardisation: it is standardising not what is made but how it is made. To use standards to dictate and control how organisations work was to extend the role of standards to new territory. To take such a step we might have firstly established that any such requirements worked — that they resulted in ways of working which improved performance.
Yet the plausibility of this Standard, and the fact that those who had an interest in maintaining it were (and still are) leading opinion, prevented such enquiries. In simple terms the Standard asks managers to say what they do, do what they say and prove it to a third party.
ISO 9000 (1994) paragraph 1: “The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing.”
To put it another way, the Standard asserts that preventing non-conformance achieves customer satisfaction. But does it? Of course it matters to customers that a product works. But there is no guarantee that the Standard will ensure even that. Furthermore, customers take a total view of an organisation — how easy it is to do business with — in respect of all things of importance to each and every customer.
ISO 9000 requires managers to “establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements”. Loosely translated this is “say what you do”. Management is supposed to “define and document its policy for quality . . . including its commitment to quality”.
What management would not declare its commitment to quality? But would they know what it means? Would they argue (as they should) that quality management is a different and better way to do business, or would they believe that ISO 9000 will take care of quality? The Standard encourages managers to think of “quality” and “business as usual” as separate and distinct. It helps managers avoid the revelation that quality means a wholly different view of management. Instead, the organisation “shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility” [for ISO 9000]. At a practical level this means only one executive might decide he or she had better learn a thing or two about quality. However, would being responsible for ISO 9000 lead to learning about quality or simply enforcing the ISO 9000 regime in an organisation?
Key to the regime is auditing. The Standard requires organisations to conduct internal quality audits to “verify whether quality activities comply with planned arrangements”. This can be loosely translated as “do you do as you say?” and the purpose of the audit is to see that you do. It was not until the 1994 review that the words were changed to “quality activities and related results”. It was a Standard which was rooted in the philosophy of inspection: fifteen years after its initial promulgation the promoters sought to extend the focus to results. But results or improvements assessed by what means? Inspection. By the time the Standard was adopted world-wide, quality thinking had moved a long way from the philosophy of inspection. It is now understood, at least by a few, that quality is achieved through managing the organisation as a system and using measures which enable managers to improve flow and reduce variation (which we explore in chapters 5 and 7). The defenders argue that there is nothing stopping a company having ISO 9000 and implementing methods for managing flow and reducing variation, but where are such companies? Few of the companies we researched, formally and informally, knew anything about this thinking. The Standard does not talk about it; moreover, the Standard effectively discourages managers from learning about it by representing quality in a different way.
According to ISO 8402 (quality vocabulary), quality is:
“The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.”
Everything we have learned about ISO 9000 suggests that the people who created this definition were thinking about the things which need to be controlled, those things which “bear on its ability . . .”. The builders of the Standard assumed that customer needs would be listed in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic — procedures for “how you do what you do” — and a “control” logic — check to see that it is done. It is a relic of the era when contractual agreements were perceived to be an important device for regulating the behaviour of suppliers. In these ways, ISO 9000 encouraged “planning for quality”.
Planning for quality sounds plausible, but it assumes many things: that the plan is the right plan, that it is feasible, that people will “do it”, that performance will improve. It is an approach which, paradoxically, leads to poor decisions. Planners of quality systems, guided by ISO 9000, start with a view of how the world should be as framed by the Standard. Understanding how an organisation is working, rather than how someone thinks it should, is a far better place from which to start change of any kind.
Yet the plausibility of this Standard, and the fact that those who had an interest in maintaining it were (and still are) leading opinion, prevented such enquiries. In simple terms the Standard asks managers to say what they do, do what they say and prove it to a third party.
ISO 9000 (1994) paragraph 1: “The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing.”
To put it another way, the Standard asserts that preventing non-conformance achieves customer satisfaction. But does it? Of course it matters to customers that a product works. But there is no guarantee that the Standard will ensure even that. Furthermore, customers take a total view of an organisation — how easy it is to do business with — in respect of all things of importance to each and every customer.
ISO 9000 requires managers to “establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements”. Loosely translated this is “say what you do”. Management is supposed to “define and document its policy for quality . . . including its commitment to quality”.
What management would not declare its commitment to quality? But would they know what it means? Would they argue (as they should) that quality management is a different and better way to do business, or would they believe that ISO 9000 will take care of quality? The Standard encourages managers to think of “quality” and “business as usual” as separate and distinct. It helps managers avoid the revelation that quality means a wholly different view of management. Instead, the organisation “shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility” [for ISO 9000]. At a practical level this means only one executive might decide he or she had better learn a thing or two about quality. However, would being responsible for ISO 9000 lead to learning about quality or simply enforcing the ISO 9000 regime in an organisation?
Key to the regime is auditing. The Standard requires organisations to conduct internal quality audits to “verify whether quality activities comply with planned arrangements”. This can be loosely translated as “do you do as you say?” and the purpose of the audit is to see that you do. It was not until the 1994 review that the words were changed to “quality activities and related results”. It was a Standard which was rooted in the philosophy of inspection: fifteen years after its initial promulgation the promoters sought to extend the focus to results. But results or improvements assessed by what means? Inspection. By the time the Standard was adopted world-wide, quality thinking had moved a long way from the philosophy of inspection. It is now understood, at least by a few, that quality is achieved through managing the organisation as a system and using measures which enable managers to improve flow and reduce variation (which we explore in chapters 5 and 7). The defenders argue that there is nothing stopping a company having ISO 9000 and implementing methods for managing flow and reducing variation, but where are such companies? Few of the companies we researched, formally and informally, knew anything about this thinking. The Standard does not talk about it; moreover, the Standard effectively discourages managers from learning about it by representing quality in a different way.
According to ISO 8402 (quality vocabulary), quality is:
“The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.”
Everything we have learned about ISO 9000 suggests that the people who created this definition were thinking about the things which need to be controlled, those things which “bear on its ability . . .”. The builders of the Standard assumed that customer needs would be listed in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic — procedures for “how you do what you do” — and a “control” logic — check to see that it is done. It is a relic of the era when contractual agreements were perceived to be an important device for regulating the behaviour of suppliers. In these ways, ISO 9000 encouraged “planning for quality”.
Planning for quality sounds plausible, but it assumes many things: that the plan is the right plan, that it is feasible, that people will “do it”, that performance will improve. It is an approach which, paradoxically, leads to poor decisions. Planners of quality systems, guided by ISO 9000, start with a view of how the world should be as framed by the Standard. Understanding how an organisation is working, rather than how someone thinks it should, is a far better place from which to start change of any kind.
Quality Management
There are two schools of thought on quality management. One views quality
management as the management of success and the other the elimination of
failure. They are both valid. Each approaches the subject from a different
angle:
The ‘success’ school is characterized by five questions (Hoyle, David and
Thompson, John, 2001)3 :
1 What are you trying to do?
2 How do you make it happen?
3 How do you know it’s right?
4 How do you know it’s the best way of doing it?
5 How do you know it’s the right thing to do?
The ‘failure elimination’ school is characterized by five different questions
1 How do you know what is needed?
2 What could affect your ability to do it right?
3 What checks are made to verify achievement?
4 How do you ensure the integrity of these checks?
5 What action is taken to prevent a recurrence of failure?
In an ideal world, if we could design products, services and processes that
could not fail we would have achieved the ultimate goal. Success means not
only that products, services and processes fulfil their function but also that the
function is what customers’ desire. Failure means not only that products,
services and processes would fail to fulfil their function but also that their
function was not what customers desired. A gold-plated mousetrap that does
not fail is not a success if no one needs a gold-plated mousetrap!
The introductory clause of ISO 9001:1994 contained a statement that the aim
of the requirements is to achieve customer satisfaction by prevention of
nonconformities. (This was indicative of the failure school of thought.) The
introductory clause of ISO 9001:2000 contains a statement that the aim is to
enhance customer satisfaction through the effective application of the quality
management system and the assurance of conformity to customer and
applicable regulatory requirements. (This is indicative of the success school of
thought.)
In reality you cannot be successful unless you know of the risks you are
taking and plan to eliminate, reduce or control them. A unification of these
approaches is what is therefore needed for organizations to achieve, sustain
and improve quality. You therefore need to approach the achievement of
quality from two different angles and answer two questions. What do we need
to do to succeed and what do we need to do to prevent failure?
Quality does not appear by chance, or if it does it may not be repeated. One
has to design quality into the products and services. It has often been said that
one cannot inspect quality into a product. A product remains the same after
inspection as it did before, so no amount of inspection will change the quality
of the product. However, what inspection does is measure quality in a way that
allows us to make decisions on whether or not to release a piece of work. Work
that passes inspection should be quality work but inspection unfortunately is
not 100% reliable. Most inspection relies on human judgement and this can be
affected by many factors, some of which are outside our control (such as the
private life, health or mood of the inspector). We may also fail to predict the
effect that our decisions have on others. Sometimes we go to great lengths in
preparing organization changes and find to our surprise that we neglected
something or underestimated the effect of something. We therefore need other
means to deliver quality products – we have to adopt practices that enable us
to achieve our objectives while preventing failures from occurring.
management as the management of success and the other the elimination of
failure. They are both valid. Each approaches the subject from a different
angle:
The ‘success’ school is characterized by five questions (Hoyle, David and
Thompson, John, 2001)3 :
1 What are you trying to do?
2 How do you make it happen?
3 How do you know it’s right?
4 How do you know it’s the best way of doing it?
5 How do you know it’s the right thing to do?
The ‘failure elimination’ school is characterized by five different questions
1 How do you know what is needed?
2 What could affect your ability to do it right?
3 What checks are made to verify achievement?
4 How do you ensure the integrity of these checks?
5 What action is taken to prevent a recurrence of failure?
In an ideal world, if we could design products, services and processes that
could not fail we would have achieved the ultimate goal. Success means not
only that products, services and processes fulfil their function but also that the
function is what customers’ desire. Failure means not only that products,
services and processes would fail to fulfil their function but also that their
function was not what customers desired. A gold-plated mousetrap that does
not fail is not a success if no one needs a gold-plated mousetrap!
The introductory clause of ISO 9001:1994 contained a statement that the aim
of the requirements is to achieve customer satisfaction by prevention of
nonconformities. (This was indicative of the failure school of thought.) The
introductory clause of ISO 9001:2000 contains a statement that the aim is to
enhance customer satisfaction through the effective application of the quality
management system and the assurance of conformity to customer and
applicable regulatory requirements. (This is indicative of the success school of
thought.)
In reality you cannot be successful unless you know of the risks you are
taking and plan to eliminate, reduce or control them. A unification of these
approaches is what is therefore needed for organizations to achieve, sustain
and improve quality. You therefore need to approach the achievement of
quality from two different angles and answer two questions. What do we need
to do to succeed and what do we need to do to prevent failure?
Quality does not appear by chance, or if it does it may not be repeated. One
has to design quality into the products and services. It has often been said that
one cannot inspect quality into a product. A product remains the same after
inspection as it did before, so no amount of inspection will change the quality
of the product. However, what inspection does is measure quality in a way that
allows us to make decisions on whether or not to release a piece of work. Work
that passes inspection should be quality work but inspection unfortunately is
not 100% reliable. Most inspection relies on human judgement and this can be
affected by many factors, some of which are outside our control (such as the
private life, health or mood of the inspector). We may also fail to predict the
effect that our decisions have on others. Sometimes we go to great lengths in
preparing organization changes and find to our surprise that we neglected
something or underestimated the effect of something. We therefore need other
means to deliver quality products – we have to adopt practices that enable us
to achieve our objectives while preventing failures from occurring.
ISO 9001:2008 Documentation Requirements
ISO 9001:2008 Documentation Requirements
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
ISO 9001:2008 Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual
documented procedures required by this International Standard
documents needed by the organization to ensure the effective planning, operation and control of its processes, and
records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:- Quality policy (clause 4.2.1.a)- Quality objectives (clause 4.2.1.a)- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:- Process maps, process flow charts and/or process descriptions- Organization charts- Specifications- Work and/or test instructions- Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
ISO 9001:2008 Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual
documented procedures required by this International Standard
documents needed by the organization to ensure the effective planning, operation and control of its processes, and
records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:- Quality policy (clause 4.2.1.a)- Quality objectives (clause 4.2.1.a)- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:- Process maps, process flow charts and/or process descriptions- Organization charts- Specifications- Work and/or test instructions- Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.
Sunday, July 26, 2009
ISO 9000 Standard Books & Magazines
Here are some of the ISO 9000 & ISO 14001 related books & magazines available for online order.
1. ISO Management Systems – English Edition (Magazine Subscription) by Amazon
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Iso Central Secretariat
ASIN: B00006KJFO
Iso Focus C-W Iso Management Systems – English ed
2. ISO Focus (Magazine Subscription) by Amazon
Magazine of the International Organization for Standardization providing a panoramic view of what is being done in international standardization, why it has been done and what will be done.
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Iso Central Secretariat
ASIN: B0001MS4E6
Iso Focus
3. ISO 9000 Quarterly Report (Magazine Subscription) by Amazon
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Rfp Report
ASIN: B00007J7K4
Iso 9000 Quarterly Report
4. A Basic Guide To ISO 14000 – Environment Management System (EMS) provides you with all of the basic information you need in ISO 14000 and ISO 14001:2004.
What is ISO14000
Benefits of ISO 14000
History of ISO 14000
ISO 14000 Certification
ISO 14000 Process Check List
Contents Of ISO 14001:2004
Key Elements Of ISO 14001:2004
Environment Management System Manual
AND MUCH, MUCH MORE!
1. ISO Management Systems – English Edition (Magazine Subscription) by Amazon
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Iso Central Secretariat
ASIN: B00006KJFO
Iso Focus C-W Iso Management Systems – English ed
2. ISO Focus (Magazine Subscription) by Amazon
Magazine of the International Organization for Standardization providing a panoramic view of what is being done in international standardization, why it has been done and what will be done.
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Iso Central Secretariat
ASIN: B0001MS4E6
Iso Focus
3. ISO 9000 Quarterly Report (Magazine Subscription) by Amazon
Format: Magazine
Shipping: Currently, item can be shipped only within the U.S.
Publisher: Rfp Report
ASIN: B00007J7K4
Iso 9000 Quarterly Report
4. A Basic Guide To ISO 14000 – Environment Management System (EMS) provides you with all of the basic information you need in ISO 14000 and ISO 14001:2004.
What is ISO14000
Benefits of ISO 14000
History of ISO 14000
ISO 14000 Certification
ISO 14000 Process Check List
Contents Of ISO 14001:2004
Key Elements Of ISO 14001:2004
Environment Management System Manual
AND MUCH, MUCH MORE!
ISO 9001 Software
Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments
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