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

Re: ISO 9001:2008 and Quality Manual

mosheeps said:

Andy.
That's exactly what I want to know - any ideas?

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That question has been answered. If you have references to ISO 9001:2000 in your documentation, remove them altogether or change them to say 9001:2008. The requirements haven't changed.

Re: ISO 9001:2008 and Quality Manual

Jim Wynne said:

That question has been answered. If you have references to ISO 9001:2000 in your documentation, remove them altogether or change them to say 9001:2008. The requirements haven't changed.

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Thanks, Jim - I know that; I just want to be sure there's notjing else.

Re: ISO 9001:2008 and Quality Manual

I'm sure your auditor would be looking for more than the simple editorial changes such as putting up 2008 in place of 2000.

In order for you to conform to 9001:2008, you will have to thoroughly review the status of your QMS to see if it conforms to all those 65 (approx.) changes/ clarifications/ additions listed in 'Annexure B' of ISO 9001:2008 (which may possibly alter your earlier interpretation and hence it might become a 'new requirement' for you) introduced in the new version. While analyzing the clarifications, if you find that your existing interpretation of ISO 9001:2000 differ from those 'clarified' in the new version, you need to analyze the associated impacts and thus make the required amendments in your QMS (including documentation changes).

Although you need to carefully go through all the changes (refer Annex B), yet some of the significant changes are (underlined words are new additions):

1. Clause 4.1 - 'type and extent of controls' are now need to be defined (not identified) within the QMS.

2. Clause 4.1 (e) - .."monitor, measure where applicable, and analyze these processes (in older version you had to measure every 'identified' process but now you may not need to measure all the processes 'determined' by you)

3. Clause 4.2.4 - "records shall be controlled' (instead of establishing & maintaining)

4. Clause 5.5.2 - MR now has to be a member of the organization's management

5. Clause 6.2.1 general - "Personnel performing work affecting conformity to product quality requirements shall be competent on the basis of appropriate education, training, skills and experience.

6. 6.2.1 (a) "determine the necessary competence for personnel performing work affecting conformity to product quality requirements,"

both the above 'changes' make a big difference especially in the context of standard's switch over from 'product quality' to 'product requirements'.

7. Clause 6.3 - Information system was added as a 'supporting service'

8. Clause 7.5.4 - it now includes 'personal data' (finds greater application in service industry)

9. Clause 8.1 General- "The organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed
a) to demonstrate conformity of the to product requirements, (the requirement now also applies to packaging, delivery, preservation, labeling etc.)

10. Clause 8.2.2 Internal Audit - Significant change from 'actions' to '"any necessary corrections and corrective actions"

11. Clause 8.3 "Where applicable, Tthe organization shall deal with nonconforming product by one or more of the following ways:...

12. Clause 8.5.2 "reviewing the effectiveness of the corrective action taken. Similar is the case for Preventive action in 8.5.3. (earlier 'review' could mean to indicate that an 'action' has been taken)

There are many more. Just ask questions to yourself to ensure that there are no (vulnerable) gaps in your system before proceeding to the 'next audit' as indicated by your CB.

Hope this helps.

Re: ISO 9001:2008 and Quality Manual

Samsung - it may be that someone needs to do that list of things but here's what we were told:
My registrar says that after I update our QM to 2008, we will comply with 2008 and in the next audit we will be certified to 2008.

It might be that some of those slight differences you indicated are in a procedure - not in the manual!

The fact is, that such 'throw away' comments by auditors are often not very helpful - while being well meant. The fact remains that there's almost nothing to do and, if the auditor was to be truly helpful they should have pointed out specific issues, where perhaps, the client wasn't fully in compliance - like the MR could have been a hired hand.

Re: ISO 9001:2008 and Quality Manual

AndyN said:

It might be that some of those slight differences you indicated are in a procedure - not in the manual!

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Just an assumption. Let the OP now clarify what he missed out.

The fact remains that there's almost nothing to do and, if the auditor was to be truly helpful they should have pointed out specific issues, where perhaps, the client wasn't fully in compliance - like the MR could have been a hired hand.

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It's very difficult for me to believe that 'there's almost nothing to do'. After all a new standard was released by the authority with plenty of changes/ clarifications based on the feedback received from all around. Why ISO felt the need for all these clarifications ? It's because they realized that most organizations were interpreting the requirements differently. If every organization were doing according to what the original version was intended at, then, IMO, ISO might not have felt the need for coming up with a new version. An addendum or supplement to 2000 version with regard to changing the QMS from 2000 to 2008 would have ended the entire episode.

So, once the OP is advised to review the system in the context of all those changes and still if he finds that every thing is in order, no sensible auditor would ever raise such an issue.

Though I agree that the auditor should have been more specific yet I believe that the auditor might not have been concerned just for the lack of reference to year 2008. OP did also indicate the same in one of his later posts:

but knowing my registrar, I don't think this was his intention.

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Re: ISO 9001:2008 and Quality Manual

I think you're making a lot of assumptions and reading something else into the post. The issues was updating the manual - you mentioned the system. Not the same thing, are they? We agree on that, but that's not when the auditor said - apparently!

You also mentioned 'sensible auditor'. Now, I'm not going to suggest the auditor is not sensible, however, I stand by my comment that auditors often make these off hand comments which may not be born from anything other than the need to say something 'authoritative'! It reads much like that to me...

Once again, if there was a problem with complying with the numerous (word only) changes (not intentions) of the 2008 version*, couldn't the auditor have been more helpful in specifying where that should be indicated? Something like 'Oh, by the way, y'know you're allowed to have corrections as well as RCA in your internal audit procedure..." Much more helpful, don't you agree? Did we read that the auditor had made a thorough investigation of the poster's management review records to see if they'd done the comprehensive review you'd done? Doesn't appear to me that happened, hence my skepticism on the value of the auditor's statement.

(*You may also remember there was huge dismay that it took 8 years to come up with so little change to the standard of any real substance)

Re: ISO 9001:2008 and Quality Manual

samsung said:

It's very difficult for me to believe that 'there's almost nothing to do'. After all a new standard was released by the authority with plenty some of changes clarifications based on the feedback received from all around who knows what.

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Fixed that for you. There were no changes in the requirements. If extensive changes are needed in a quality manual because of the 2008 changes, the problem is with the manual.

Re: ISO 9001:2008 and Quality Manual

samsung said:

It's very difficult for me to believe that 'there's almost nothing to do'. After all a new standard was released by the authority with plenty of changes/ clarifications based on the feedback received from all around. Why ISO felt the need for all these clarifications ? It's because they realized that most organizations were interpreting the requirements differently. If every organization were doing according to what the original version was intended at, then, IMO, ISO might not have felt the need for coming up with a new version. An addendum or supplement to 2000 version with regard to changing the QMS from 2000 to 2008 would have ended the entire episode.

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You obviously don't understand the "business of standards". Your perception of ISO's motives for the ISO 9001:2008 revision are too naive. An addendum is provided for free. A new edition of the standard requires purchasing the document. ISO 9001 is the cash cow of all ISO Standards. If ISO had their way, the document would be revised clarified every year. Do yourself a favor and read the The Next version of ISO 9001 - Any news? thread.

PS. ISO started now selling DRAFTS of standards.

Re: ISO 9001:2008 and Quality Manual

Bear in mind, folks, the quality manuals do not need to refer to ISO 9001:2008 throughout. Take this opportunity to refer to ISO 9001 in a generic sense. When I develop manuals, the only place I mention the current version of the standard is near the beginning, when I mention it is compliant "to ISO 9001:2008," and will consider revisions in a reasonable timeframe when new versions are released. The rest of the time, if mentioned, it is just "ISO 9001," or "the standard."

Re: ISO 9001:2008 and Quality Manual

If both the versions of 9001 are same, means there are absolutely no changes, then it shouldn't make any difference whether you call it 2000 or 2008; if one writes 2000, it means 2008 or even if one writes 2008, it should mean 2000.

If two objects are exactly alike and fit into the definition of, let's say, 'square', then both are 'squares' without any adjectives.