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 9000may 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.
