Summary of ISO 9001:2000 and ISO 9001:2008 Changes

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
Summary of Changes - ISO 9001:2000 and ISO 9001:2008

It is said that the changes in ISO 9001:2008 are primarily clarifications that are intended to provide clarity and thus improve understanding of the existing (ISO 9001:2000) requirements.

I also understand most of the changes are for ease of use and improved compatibility with ISO 14001:2004.

Details, please.

Who wants to start?
 
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M

MsHeeler

#2
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Do you have the short version of the changes?

Msheeler
 

SteveK

Trusted Information Resource
#7
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Hi all,

I received my BS EN ISO 9001:2008 copy (from BSI) yesterday. Apart from the seeming cosmetic changes in the text etc; in my old 2000 EN ISO version there are two ‘Forwards’ and only one in the new 2008 version. This does not sound like much, except in the first ‘Forward’ of the 2000 version it has the section on ‘permissible exclusions’ e.g. module E sub-clause 7.5.2; validation of processes for production and service provision, which is not in the 2008 version. This has an impact on my QMS by the fact I invoked this (i.e. in my quality manual) because for our products (medical devices) we can verify our output by monitoring and measurement. At my last surveillance audit I was asked if I had any exclusions, and I explained my reasoning for this exclusion – auditor accepted my stance based on this module E case. Now it is not there, looks like I will have to conduct some changes:mg:. Any comments on this?

Steve
 
A

Al Hector

#8
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Hello Steve,

After a quick search I found that that Decision 93/465/EEC was repealed by Decision No 768/2008/EC and I suppose that for this reason has disappear this forward in EN ISO 9001:2008.

Anyway I think that your exclusions can still be ok based on the paragraph 1.2 Application where I guess (I have only the final draft of the ISO 9001:2008) that is still written “Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.”
Alin
 

SteveK

Trusted Information Resource
#9
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Hi Al,

Thanks for the clarification (actually there are two 'Forwards' in the 2008 version - the first one just does not now have the exclusion part for the reason you indicated). The approach you imply (reference in clause 1.2 - also the variation in ISO 13485) is what I have planned to take with respect to exclusions in clause 7 (only) - I just have to change some wording/references in my QA manual. For those who do not yet have a published copy of the 9001:2008, it does indicate all the changes (apart from that 'first' forward and with a typo in the first clause 8.3 reference - quality document?!:read:) to the 2000 version in an appendix (B).

Steve
:thanks:
 
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