ISO9001:2000 Update
ISO9001:2000 was released at the end of 2000,
and in the last year, a DRAFT revised standard ISO/DIS 9001 has
been available for comment. Voting on the Draft ended in
February 2008 and it is expected that ISO9001:2008 will be
available towards the end of the year. Whereas ISO9001:2000 was
a major revision to the ISO9001:1994 standard, introducing some
new concepts and requirements and making the standard much
easier for nonmanufacturing organisations to implement, the
changes to the standard seen in the Draft 2008 version are
fairly minor and should not cause too many problems to
organisations operating ISO9001:2000. We look at a few of the
changes below.
The concept of risk is introduced “
The
design and implementation of an organisation’s quality
management system is influenced by: its business environment,
changes in that environment, or risks associated with that
environment……..” This continues the outward looking focus of
the standard that started in the 2000 version.
The definition of product is clarified – it now
says “
In this
International Standard, the term “product” applies to the
product intended for, or required by, a customer or the product
realisation processes. This applies to any intended output
resulting from product realisation processes, including
purchasing”. This makes it very clear that all customer
deliverables should be part of the standard.
The requirement for
appointing a management representative now says
“The management representative
must be a member of the organisation’s management”. This
places the emphasis firmly within the management team and
suggests that it cannot be passed on to an outside consultant.
Quality Management has to be firmly seen as the responsibility
of the organisation.
There have been a couple of small changes in
Clause 6.2.2. Competence and training awareness. Personnel must
be competent to perform
“work affecting conformity to product “, rather than “affecting
product quality” thus competency now covers all product
requirements. Training also has to be evaluated to “ensure
that the necessary competence has been achieved”. This
implies that organisations will need to consider how to
demonstrate that competence has been achieved.
In Clause 6.3 Infrastructure – “Information
systems” have been included in supporting services,
recognising the importance of these systems in modern
management.
A note has been added to Clause 6.4 Work
Environment that provides guidance as to what is meant “The
term “work environment” relates to conditions under which work
is performed including physical, environmental and other factors
(such as noise, temperature, humidity, lighting, or weather).
There have also been many other changes that aim
to improve clarity and understanding. This document is still a
Draft, and a full schedule of changes will be
provided once the standard has been released.
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