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

Re: ISO 9001:2008 and Quality Manual

Helmut Jilling said:

Oh c'mon. A single notation notation that the QMS is based on and meets the requirements of ISO 9001, or TS-16949, or whatever, is a "harmful" thing?. Especially when a company is spending a lot of time and money getting certified to the standard. And trying to promote it within the company. Seriously, Jim, I think you are letting your anti-ISO certification bias show a bit much on this one.

Can the QMS be done without mentioning it, I suppose. But, I still think it is a good thing. I just recommend to do it simple and don't plaster the specific reference everywhere. Just state it once, and let any other references be more generic.

Some people still like ISO, Jimmie-boy...they even still buy flags...

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You didn't answer the question. A good thing how? How is documentation that makes even a single reference to the standard better than documentation that doesn't? This is not about flags--if the intrinsic value of compliance is the primary motivator, the less emphasis on the standard in the documentation the better. A compliant organization may or may not opt for certification, so my position on certification isn't relevant to the question at hand, unless you think that the employees of certified companies would be prevented from celebration and feeling good about things if there were no mention of the standard in the documentation.

Re: ISO 9001:2008 and Quality Manual

AndyN said:

Samsung - no one has said both revisions are the same! As we know with the English language, words can be different but have the same meaning. Words have been changed and added to the standard, but the meaning hasn't been added to or changed in any substantial manner.

I fear that over analysis of such things will lead to missing the bigger picture, whether it's this or categorization of audit findings, etc. leading to the confusion of those who are new or unsure of how to implement systems.

Implementing ISO 9001 really isn't technically challenging to most organizations, in my experience - and for all the people I've assisted - this type of over analysis and nit picking through the standard is totally unnecessary.

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Andy, it's not creating any confusion whatsoever especially in the minds of those who are new on the forum or in the QMS thing; rather, as I believe, it helps to erase out the confusion by reminding them to look into their QMS with a different mind set.

When I went through the 2008 version for the first time, I did compare it with the existing practices and found many gaps. Examples are:

1. We were not controlling the 'records' but now we do.

2. We didn't ever consider IT as a support process but having gone through the new version, we had to cover it under the QMS.

3. We used to evaluate competence of only those persons who were looking after 'product quality' (then requirement of 9001) but now it isn't like that, we have to cover competence evaluation of even the drivers who transport our cement and the guys who mark the batch no. on the bags.

4. You won't believe we never bothered to see if the CAs implemented by our engineers were quite effective because no one ever told us to do that. We used to review the 'actions' but just to see if it was implemented. But now it's an indispensable part of the process.

5. We never took the outsourced processes the way the standard now proposes; i.e.; 'defining the type & extent of controls' whereas we had simply 'identified' the controls and that too outside the realms of QMS.

I don't exactly remember how many of the things we didn't use to do earlier or had interpreted differently but the fact is that we never had an issue with the CB because until the publication of the new standard, things were also not clear to most CBs (at least to our CB) or they didn't have any ground to treat them otherwise. The new version did help us improve our QMS in many respects. It's sure and certain that if we hadn't incorporated all the above cited activities into the system, our QMS would never conform to ISO 9001:2008.

Likewise there can be more practitioners who might not be doing the way the standard has NOW envisaged.

I still emphasize what Big Jim has also advised in this thread:

Big Jim said:

if you have implemented your quality management system the way the framers envisioned it, no changes would be needed. If there had been a misunderstanding, this was an opportunity to get back on course.

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And there's nothing wrong at least in revisiting the system just to confirm that it still conforms.

Re: ISO 9001:2008 and Quality Manual

Hi Mosheeps,

Did you analyze what made the auditor raise this issue ? Was your QMS already in compliance in every respect (especially with regard to all the 'clarifications, additions' etc.) when the new standard was released?

One last question - What changes you had to make or now propose to make after your CB audit?

Re: ISO 9001:2008 and Quality Manual

Jim Wynne said:

You didn't answer the question. A good thing how? How is documentation that makes even a single reference to the standard better than documentation that doesn't? This is not about flags--if the intrinsic value of compliance is the primary motivator, the less emphasis on the standard in the documentation the better. A compliant organization may or may not opt for certification, so my position on certification isn't relevant to the question at hand, unless you think that the employees of certified companies would be prevented from celebration and feeling good about things if there were no mention of the standard in the documentation.

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I think I answered it very clearly in the first paragraph, as noted below:


1. ...Especially when a company is spending a lot of time and money getting certified to the standard. Thus, they are pleased or proud of their efforts.

2. ...And trying to promote it within the company. They want people to buy into the implementation effort. Why would they be inclined to hide the connection.

We'll have to choose to disagree on this one. I agree with your principle of keeping things simple, but I think you are making a mountain out of a speck.

Re: ISO 9001:2008 and Quality Manual

Sidney Vianna said:

Change denotes something different. Upon reading and understanding the CLARIFICATIONS, most organizations realize that there is NO NEED to revise anything in their manuals, command media, processes and systems.

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...but not all and my contentions are aimed only at those (remaining) organizations (ours' had been one among them) that failed to understand the previous interpretations correctly or simply they couldn't just realize beforehand what the new version was going to contain.

Re: ISO 9001:2008 and Quality Manual

samsung said:

...but not all and my contentions are aimed only at those (remaining) organizations (ours' had been one among them) that failed to understand the previous interpretations correctly or simply they couldn't just realize beforehand what the new version was going to contain.

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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...

Re: ISO 9001:2008 and Quality Manual

samsung said:

Hi Mosheeps,

Did you analyze what made the auditor raise this issue ? Was your QMS already in compliance in every respect (especially with regard to all the 'clarifications, additions' etc.) when the new standard was released?

One last question - What changes you had to make or now propose to make after your CB audit?

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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?

Re: ISO 9001:2008 and Quality Manual

Mosheeps,

I'm sorry your auditor left you with such a vague understanding of what had to be done. Best thing to do if you don't understand something, is to ask the auditor for clarification before they go. Since it's after the fact, suggest if you're still unsure, ask the certifier to provide some more guidance.

I agree with Andy (and others) - the comment is very vague.

If it's just as simple as taking out any reference to ISO 9001:2000 and replacing it with ISO 9001:2008 (if you wish) or even better in my opinion, just 'ISO 9001', then that should do it. But you see, we're guessing a bit at what your auditor meant - and the big point about a good, competent auditor is that they should not leave people behind them trying to figure out what the problem is! The 'problem' should be clearly stated, along with the evidence, so that you know what to focus on!

samsung said:

Hi Mosheeps,
Did you analyze what made the auditor raise this issue ? Was your QMS already in compliance in every respect (especially with regard to all the 'clarifications, additions' etc.) when the new standard was released?

One last question - What changes you had to make or now propose to make after your CB audit?

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Samsung, I agree with Andy's comments. It is the job of the auditor if they find an issue, to explain clearly what it is and made them raise it. The auditee shouldn't be left having to play guessing games!! That's a recipe for a lot of time-wasting and angst as well. As Andy said, what service are you actually paying for?

Re: ISO 9001:2008 and Quality Manual

samsung said:

When I went through the 2008 version for the first time, I did compare it with the existing practices and found many gaps. Examples are:

1. We were not controlling the 'records' but now we do.

2. We didn't ever consider IT as a support process but having gone through the new version, we had to cover it under the QMS.

3. We used to evaluate competence of only those persons who were looking after 'product quality' (then requirement of 9001) but now it isn't like that, we have to cover competence evaluation of even the drivers who transport our cement and the guys who mark the batch no. on the bags.

4. You won't believe we never bothered to see if the CAs implemented by our engineers were quite effective because no one ever told us to do that. We used to review the 'actions' but just to see if it was implemented. But now it's an indispensable part of the process.

5. We never took the outsourced processes the way the standard now proposes; i.e.; 'defining the type & extent of controls' whereas we had simply 'identified' the controls and that too outside the realms of QMS.

I don't exactly remember how many of the things we didn't use to do earlier or had interpreted differently but the fact is that we never had an issue with the CB because until the publication of the new standard, things were also not clear to most CBs (at least to our CB) or they didn't have any ground to treat them otherwise. The new version did help us improve our QMS in many respects.

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I'm really glad the new version helped you improve - I'm sure it was one of the purposes of such revisions and annotations and minor tweakings as were in it. Keep it up. And yes, of course it's worth revisiting a system to see how it can be improved.

But I contend that all of the things you've listed above were already required by ISO 9001 (the 2000 version). The 2008 version didn't, you will recall, introduce any new requirements. All these things you've mentioned were in it - but clearly not fully understood.

It's also good if your CB didn't fully understand this before and do now. But if I were advising your top management, I'd have advised them to change certifiers by now. Because if they and their auditors had to wait for this kind of fine detail clarification before they 'got' it, I'd want better auditors. Who already had and some time ago.

Re: ISO 9001:2008 and Quality Manual

Jim Wynne said:

the less emphasis on the standard in the documentation the better.

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Not necessarily. Some organisations really like to put it in their documentation and make a 'big deal' about it. Often the case with organisations new to the Standard and the whole business of getting certified. I know - I quite often suggest they not do it... but almost invariably they want to!

I think sometimes those of us who deal with Standards and certification everyday and see it as 'just how it is' may sometimes forget that it's a big deal for some of our clients to reach their goal. And if they like to put it in their doco, who's to mind? Theirs after all. Sometimes they get less picky about having it in there as time wears on...