Perceptions of ISO 9000 and its derivatives 81
product met specified requirements. In other words, it required the system to cause con-
formity with requirements. A set of documents alone cannot cause product to conform
to requirements. When people change the system they invariably mean that they update
or revise the system documentation. When the system is audited invariably it is the docu-
mentation that is checked and compliance with documentation verified. There is often lit-
tle consideration given to processes, resources, behaviors or results. As few people seem
to have read ISO 8402, it is not surprising that the documents are perceived as a system.
(Note: In talking with over 600 representatives of UK companies in 1999 and 2000 the
author discovered that less than 10% had read ISO 8402.) But ISO 8402 defined a sys-
tem rather differently. A quality system was defined as the organization structure, pro-
cedures, processes and resources needed to implement quality management – clearly
not a set of documents. The 1994 version QS-9000 required a system to be established
and documented. If the system was a set of documents, why then require it to be estab-
lished as well as documented? (We have no evidence to show that the authors understood
the difference so it is rather patronizing to speculate that they did!)
The persistence of the auditors to require documentation led to situations where docu-
mentation only existed in case something went wrong – in case someone was knocked
down by a bus. While the unexpected can result in disaster for an organization it needs
to be based on a risk assessment. There was often no assessment of the risks or the
consequences. Unlike ISO/TS 16949, which requires contingency plans and failure
mode and effects analysis (FMEA). This could have been avoided simply by asking the
question: “So what?” So there are no written instructions for someone to take over the
job but even if there were, would it guarantee there were no hiccups? Would it ensure
product quality? Often the new person sees improvements that the previous person
missed or deliberately chose not to make; often the written instructions are of no use
without training; and often the written instructions are of no value whatsoever.
There has also been a perception in the service industries that ISO 9000 quality
systems only deals with the procedural aspects of a service and not the professional
aspects. For instance in a medical practice, the ISO 9000 quality system is often used
only for processing patients and not for the medical treatment. In legal practices, the
quality system again has been focused only on the administrative aspects and not on
the legal issues. The argument for this is that there are professional bodies that deal
with the professional side of the business. In other words, the quality system only
addresses the non-technical issues, leaving the profession to address the technical
issues. This is not quality management. The quality of the service depends on both
the technical and non-technical aspects of the service. Patients who are given the
wrong advice would remain dissatisfied even if their papers were in order or even if
they were given courteous attention and advised promptly. To achieve quality one has
to consider both the product and the service. A faulty product delivered on time, within
budget and with a smile remains a faulty product!
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