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.
Showing posts with label ISO 9000. Show all posts
Showing posts with label ISO 9000. Show all posts
Friday, October 9, 2009
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.
ISO 9000 vs Quality
ISO 9000 was conceived to bring about an improvement in product quality. It
was believed that if organizations were able to demonstrate they were
operating a quality system that met international standards, customers would
gain greater confidence in the quality of products they purchased. It was also
believed that by operating in accordance with documented procedures, errors
would be reduced and consistency of output ensured. If you find the best way
of achieving a result, put in place measures to prevent variation, document it
and train others to apply it, it follows that the results produced should be
consistently good.
The requirements of the standard were perceived to be a list of things to do
to achieve quality. The ISO co-ordinator would often draw up a plan based on
the following logic:
1. We have to identify resource requirements so I will write a procedure on
identifying resource requirements
2. We have to produce quality plans so I will write a procedure on producing
quality plans
3. We have to record contract review so I will write a procedure on recording
contract reviews
4. We have to identify design changes so I will write a procedure on identifying
design changes
The requirements in the standard were often not expressed as results to be
achieved. Requirements for a documented procedure to be established resulted
in just that. Invariably the objectives of the procedure were to define something
rather than to achieve something. This led to documentation without any clear
purpose that related to the achievement of quality. Those producing the
documentation were focusing on meeting the standard not on achieving quality.
Those producing the product were focusing on meeting the customer
requirement but the two were often out of sync. As quality assurance became
synonymous with procedures, so people perceived that they could achieve
quality by following procedures. The dominance of procedures to the exclusion
of performance is a misunderstanding of the implementers. The standard
required a documented system that ensured product met specified requirements – a
clear purpose. Once again the implementers lost sight of the objective. Or was it
that they knew the objective but in order to meet it, the culture would have to
change and if they could get the badge without doing so, why should they?
Issuing a procedure was considered to equate to task completed. Unfortu-
nately, for those on the receiving end, the procedures were filed and forgotten.
When the auditor came around, the individual was found to be totally
unaware of the ‘procedure’ and consequently found noncompliant with it.
However, the auditor would discover that the individual was doing the right
things so the corrective action was inevitably to change the procedure. The
process of issuing procedures was not questioned, the individual concerned
was blamed for not knowing the procedure and the whole episode failed to
make any positive contribution to the achievement of quality. But it left the
impression on the individual that quality was all about following procedures.
It also left the impression that quality was about consistency and providing
you did what you said you would do regardless of it being in the interests of
satisfying customers, it was OK. One is left wondering whether anyone
consulted the dictionary in which quality is defined as a degree of excellence?
Another problem was that those who were to implement requirements were
often excluded from the process. Instead of enquiring as to the best way of
meeting a requirement, those in charge of ISO 9000 implementation assumed
that issuing procedures would in fact cause compliance with requirements. It
requires a study of the way work gets done to appreciate how best to meet a
requirement. Procedures were required to be documented and the range and
detail was intended to be appropriate to the complexity of the work, the
methods used and the skills and training needed. The standard also only
required work instructions where their absence would adversely affect quality.
It is as though the people concerned did not read the requirement properly or
had no curiosity to find out for themselves what ISO had to say about
procedures – they were all too ready to be told what to do without questioning
why they should be doing it.
More often than not, the topics covered by the standard were only a sample
of all the things that need to be done to achieve the organization’s objectives.
The way the standard classified the topics was also often not appropriate to the
way work was performed. As a consequence, procedures failed to be
implemented because they mirrored the standard and not the work. ISO 9000
may have required documented procedures but it did not insist that they be
produced in separate documents, with titles or an identification convention
that was traceable to the requirements.
Critics argue (Seddon, John, 2000)3 that ISO 9000 did not enable organiza-
tions to reduce variation as a result of following the procedures. It is true that
ISO 9000 did not explain the theory of variation – it could have done, but
perhaps it was felt that this was better handled by the wealth of literature
available at the time. However, ISO 9000 did require organizations to identify
where the use of statistical techniques was necessary for establishing,
controlling and verifying process capability but this was often misunderstood.
Clause 4.14 of ISO 9001 required corrective action procedures – procedures to
identify variation and eliminate the cause so this should have resulted in a
reduction in variation. The procedures did not always focus on results – they
tended to focus on transactions – sending information or product from A to B.
The concept of corrective action was often misunderstood. It was believed to be
about fixing the problem and preventive action was believed to be about
preventing recurrence. Had users read ISO 8402 they should have been
enlightened. Had they read Deming they would have been enlightened but in
many cases the language of ISO 9000 was a deterrent to learning. Had the
auditors understood variation, they too could have assisted in clarifying these
issues but they too seemed ignorant – willing to regard clause 4.20 as not
applicable in many cases.
Clause 4.6 of the undervalued and forgotten standard ISO 9000 –1 starts with
‘The International Standards in the ISO 9000 family are founded upon the
understanding that all work is accomplished by a process.’ In clause 4.7 it starts
with ‘Every organization exists to accomplish value-adding work. The work is
accomplished through a network of processes’ In clause 4.8 it starts with ‘It is
conventional to speak of quality systems as consisting of a number of elements.
The quality system is carried out by means of processes which exist both within
and across functions’ Alas, few people read ISO 9000–1 and as a result the
baggage that had amassed was difficult to shed especially because there were
few if any certification bodies suggesting that the guidance contained in ISO
9000 –1 should be applied. Unfortunately, this message from ISO 9000 –1 was not
conveyed through the requirements of ISO 9001. ISO 9001 was not intended as
a design tool. It was produced for contractual and assessment purposes but was
used as a design tool instead of ISO 9000 –1 and ISO 9004 –1.
was believed that if organizations were able to demonstrate they were
operating a quality system that met international standards, customers would
gain greater confidence in the quality of products they purchased. It was also
believed that by operating in accordance with documented procedures, errors
would be reduced and consistency of output ensured. If you find the best way
of achieving a result, put in place measures to prevent variation, document it
and train others to apply it, it follows that the results produced should be
consistently good.
The requirements of the standard were perceived to be a list of things to do
to achieve quality. The ISO co-ordinator would often draw up a plan based on
the following logic:
1. We have to identify resource requirements so I will write a procedure on
identifying resource requirements
2. We have to produce quality plans so I will write a procedure on producing
quality plans
3. We have to record contract review so I will write a procedure on recording
contract reviews
4. We have to identify design changes so I will write a procedure on identifying
design changes
The requirements in the standard were often not expressed as results to be
achieved. Requirements for a documented procedure to be established resulted
in just that. Invariably the objectives of the procedure were to define something
rather than to achieve something. This led to documentation without any clear
purpose that related to the achievement of quality. Those producing the
documentation were focusing on meeting the standard not on achieving quality.
Those producing the product were focusing on meeting the customer
requirement but the two were often out of sync. As quality assurance became
synonymous with procedures, so people perceived that they could achieve
quality by following procedures. The dominance of procedures to the exclusion
of performance is a misunderstanding of the implementers. The standard
required a documented system that ensured product met specified requirements – a
clear purpose. Once again the implementers lost sight of the objective. Or was it
that they knew the objective but in order to meet it, the culture would have to
change and if they could get the badge without doing so, why should they?
Issuing a procedure was considered to equate to task completed. Unfortu-
nately, for those on the receiving end, the procedures were filed and forgotten.
When the auditor came around, the individual was found to be totally
unaware of the ‘procedure’ and consequently found noncompliant with it.
However, the auditor would discover that the individual was doing the right
things so the corrective action was inevitably to change the procedure. The
process of issuing procedures was not questioned, the individual concerned
was blamed for not knowing the procedure and the whole episode failed to
make any positive contribution to the achievement of quality. But it left the
impression on the individual that quality was all about following procedures.
It also left the impression that quality was about consistency and providing
you did what you said you would do regardless of it being in the interests of
satisfying customers, it was OK. One is left wondering whether anyone
consulted the dictionary in which quality is defined as a degree of excellence?
Another problem was that those who were to implement requirements were
often excluded from the process. Instead of enquiring as to the best way of
meeting a requirement, those in charge of ISO 9000 implementation assumed
that issuing procedures would in fact cause compliance with requirements. It
requires a study of the way work gets done to appreciate how best to meet a
requirement. Procedures were required to be documented and the range and
detail was intended to be appropriate to the complexity of the work, the
methods used and the skills and training needed. The standard also only
required work instructions where their absence would adversely affect quality.
It is as though the people concerned did not read the requirement properly or
had no curiosity to find out for themselves what ISO had to say about
procedures – they were all too ready to be told what to do without questioning
why they should be doing it.
More often than not, the topics covered by the standard were only a sample
of all the things that need to be done to achieve the organization’s objectives.
The way the standard classified the topics was also often not appropriate to the
way work was performed. As a consequence, procedures failed to be
implemented because they mirrored the standard and not the work. ISO 9000
may have required documented procedures but it did not insist that they be
produced in separate documents, with titles or an identification convention
that was traceable to the requirements.
Critics argue (Seddon, John, 2000)3 that ISO 9000 did not enable organiza-
tions to reduce variation as a result of following the procedures. It is true that
ISO 9000 did not explain the theory of variation – it could have done, but
perhaps it was felt that this was better handled by the wealth of literature
available at the time. However, ISO 9000 did require organizations to identify
where the use of statistical techniques was necessary for establishing,
controlling and verifying process capability but this was often misunderstood.
Clause 4.14 of ISO 9001 required corrective action procedures – procedures to
identify variation and eliminate the cause so this should have resulted in a
reduction in variation. The procedures did not always focus on results – they
tended to focus on transactions – sending information or product from A to B.
The concept of corrective action was often misunderstood. It was believed to be
about fixing the problem and preventive action was believed to be about
preventing recurrence. Had users read ISO 8402 they should have been
enlightened. Had they read Deming they would have been enlightened but in
many cases the language of ISO 9000 was a deterrent to learning. Had the
auditors understood variation, they too could have assisted in clarifying these
issues but they too seemed ignorant – willing to regard clause 4.20 as not
applicable in many cases.
Clause 4.6 of the undervalued and forgotten standard ISO 9000 –1 starts with
‘The International Standards in the ISO 9000 family are founded upon the
understanding that all work is accomplished by a process.’ In clause 4.7 it starts
with ‘Every organization exists to accomplish value-adding work. The work is
accomplished through a network of processes’ In clause 4.8 it starts with ‘It is
conventional to speak of quality systems as consisting of a number of elements.
The quality system is carried out by means of processes which exist both within
and across functions’ Alas, few people read ISO 9000–1 and as a result the
baggage that had amassed was difficult to shed especially because there were
few if any certification bodies suggesting that the guidance contained in ISO
9000 –1 should be applied. Unfortunately, this message from ISO 9000 –1 was not
conveyed through the requirements of ISO 9001. ISO 9001 was not intended as
a design tool. It was produced for contractual and assessment purposes but was
used as a design tool instead of ISO 9000 –1 and ISO 9004 –1.
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