Updating a Quality Manual from ISO 9001:2000 to ISO 9001:2008

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samsung

Re: ISO 9001:2008 and Quality Manual

So, what was your CB auditor looking at? If you didn't meet the 2000 version requirements and the auditor waited until 2008 to point them out, what were they thinking about? Sounds like time to change CB auditor...

Hellow AndyN and Jane B.,

I sincerely appreciate your involvement in this discussion. As I know, being a lead auditor & a consultant as well, you as well as many others on the Cove are experts of Management Systems and thus you obviously have a different perspective for the QMS requirements than the ordinary and unsophisticated practitioners who don't have so much of in-depth knowledge of this subject. As I said earlier, we didn't know that we weren't meeting all the requirements of the 2000 version because they might be existing since 2000 as you said, but in 'disguise' and probably this was the reason the ISO body had to come forward with a fresh 'draft' with certain clarifications/word additions/deletion and these (otherwise) simple clarifications came to many as 'new or changed requirements'. Now they are clearly written and hence, are understood the way they mean and thus being implemented the way they are envisaged.

If the CB's are at fault, the accreditation bodies (RvA in this case) are equally responsible for such a lapse.

And one thing that I must highlight is that even after so much clarifications by ISO itself, many of the 'apparently simple' requirements are still unclear to many of the non-experts and perhaps that's why people have been constantly putting up their queries for clarification/ discussion for last so many years on Elsmar.

Thanks.
 

somashekar

Leader
Admin
Re: ISO 9001:2008 and Quality Manual

Great going on the manual ...
The clause 4.2.2 is untouched so it remains same in ISO9001:2008 (Thank the lord ...)
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions
(see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.


So revisit the manual and check for :
the scope of the quality management system, including details of and justification for any exclusions needs change .. ? change it, else keep it as it is.
the documented procedures established for the quality management system, or reference to them needs change .. ? change it, else keep it as it is.
a description of the interaction between the processes of the quality management system needs change .. ? change it, else keep it as it is.

In this process if you have used anywhere in your manual the word "ISO 9001:2000" >> change it to "ISO9001:2008" , else keep it as it is.

However based on the standard of 2008 you may have many things to do in the actual procedures and interactions between the processes as brought out by Samsung, and as applicable to your organization.
 
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S

samsung

Re: ISO 9001:2008 and Quality Manual

Samsung - don't you think it's the auditor's job to do the analysis, in order to justify their comment? Surely, they should have done an audit to identify where in the system/documentation/manual - as I did in my example - there is a requirement that wasn't being met.

Or are you suggesting that this kind of vague 'just fix the manual' type of comment is all that's required, sending the OP into a 'needle in a haystack' trying to uncover exactly what the auditor saw/meant? If so, what service are you paying your CB auditor for?

Yes, I do agree that the auditor should have made it pretty clear at the first instance but when s/he didn't do it and nor did the OP ask the auditor for a clarification (which he can still do), the onus now rests on OP's shoulders to guess & analyze if a clue strikes as to what the auditor wanted him to do.

Surely, I would expect an auditor to be as much professional as the profession demands and I also agree with Jane's comment that "The auditee shouldn't be left having to play guessing games!!" Absolutely correct. But inspite of this, the issue beforehand is to provide the OP with some solution to his problem which he innocently accepted to address. Now, he's also of the opinion (as he indicated somewhere) that the auditor atleast didn't mean to just change the reference from 2000 to 2008. The only thing that remains to be 'guessed' & advised now is to look into the QMS to appraise if it needs to be updated (that's what the auditor asked) with respect to the changes (IF ANY) brought about by the recent clarifications in the new version.
 
S

selva kumar

Re: ISO 9001:2008 and Quality Manual

can i see your quality manual sir
 
B

barkha

Re: ISO 9001:2008 and Quality Manual

you will have to change the numbering on the manual
change 2000 to 2008
make changes on your amendment sheet saying that you are upgrading ISO 9001:200 To ISO 9001:2008QMS

If there have been changes in the organisation like designation change, organization chart or any thing make the relevant changes to the manual if no changes in the procedure no need to do anything to it.

REad the new standards, make the relevant changes issue the manual to everyone and call the auditor to issue you new certificate
 

poh.s.lim

Poh S. Lim (Minuteman MMXXIII)
Re: ISO 9001:2008 and Quality Manual

All the instances where the manual reads ISO 9001:2000 should be relaced with ISO 9001:2008, or as I suggested before, and to reduce the environmental impact of unnecessarily reprinting manuals, you can use a black ink pen and do the ISO 9001:2000:biglaugh:
Sidney, gosh, I thinks that's a very cool suggestion, besides being environmentally friendly and not having to re-print kilograms of paper just to change that one itsy-bitsy thing.
 
J

jamesscs

Re: ISO 9001:2008 and Quality Manual

The most significant issue is "how do you manage risks"?
 
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