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

[Marc]

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?

[MsHeeler]

Do you have the short version of the changes?

Msheeler

[Esthyl]

I found this file in www.iso.org, hope it helps!

[sathis]

I Have a Summary of changes , but it is for DRAFT Standard

Hope there is no much change between DRAFT and ORIGINAL


Sathish

[Al Hector]

Hello,
you can found one here
http://www.whittingtonassociates.com...-9001-2008.pdf

This is an update to the file previous posted one Cove forum by Mr. Whittington.(My thanks to him).

Alin

[Stijloor]

Originally Posted by Marc

I assume there are no changes to the text. No one is replying.

They have....

Stijloor.

[SteveK]

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. Any comments on this?

Steve

[Al Hector]

Originally Posted by SteveK

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. Any comments on this?

Steve

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