ISO 9001:2000 - Making the Transition (Part 1)
Jeff Ryall
Once you have reviewed the changes to the new standard, it can really look like a lot of work to amend your current system to address the new requirements. The whole structure of the standard has changed, and there seems to be so many new requirements that it can appear overwhelming.
Yet, if the transition is approached from a practical business perspective, the change process can be handled with a minimum of fuss. And you can achieve not only a successful audit outcome, but also attain a management system that really works for the business. Some of our clients who have been certified to the new standard can attest to this.
The first step is to take a different approach to the standard structure.
In the Quality Standards Handbook, we took the 1994 version of the standard and reconstructed it around 3 key themes:
Management of product
Management of the system
Management of the organisation
We recommend you retain this approach with the new standard,
to see how simply it all falls into place. (This is the
structure we are retaining for the new edition, due out
in a couple of months.)
1. Management of Product
This contains all of Section 7 of ISO 9001:2000, as well as:
8.2.3 & 4 (process & product monitoring) and
8.3 (Control of nonconforming product).
When you read these sections, you will notice that, really, nothing fundamental has changed, other than a more modern approach to identifying customer requirements. Nor would you expect much change - most of these issues were sorted out 30 years ago.
So all you really need to do here is review the way that issues related to customer requirements are dealt with in the system. Especially, how well do you handle the list in section 7.2.1 (Determination of requirements related to product)?
2. Management of System
This collection of requirements deals with all of the aspects of the system that relate to system maintenance. It includes:
General documentation requirements (4.2.1), which is concerned
largely with the architecture and structure of the system.
The Quality Manual update (4.2.2) - there are a few things
that you need to consider putting into your manual - and
some you might consider taking out.
Control of documents (4.2.3): essentially no changes required
here.
Control of records (4.2.4): again, no changes required.
Internal audit (8.2.2) requirements have been ramped up
a little, but it is mainly intended to provide better visible
control of a process that ought be working well anyway.
Corrective and preventive action (8.5.2 & 8.5.3) are
much the same as before. Check the way that you handle
the records requirements in these sections. (As an aside,
it is interesting to note that the standards writers have
attached Preventive Action at the very end of the standard,
when surely it is one of the first things that needs to
be addressed in any management system.)
3. Management of the Organsation
This is where the BIG changes are to be found. Look for Part 2 of this article in the next Executive Briefing to see how to handle them effectively, so that you create not just an improved quality system, but a real management system that works for the business in the way it deals with quality!
Watch for the coming roadshow seminars, and ask us how our specially-developed System Development Support Program™ will help you improve your business and reduce your risks - and meet the requirements of ISO 9001:2000 as a consequence