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

Re: ISO 9001:2008 and Quality Manual

Jim Wynne said:

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.

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May the problem lies with the manual and that's what the auditor asked OP to look into.

BTW, there are more than 65 changes. I don't say that every change warrants a change in manual or other documents. The message is just to review the existing documentation/ processes/ procedures and based on the analysis of the 'revised' interpretation/ changes listed in 'Annexure B', if one finds any gaps, those are to be fixed.

"....who knows what"
Here it is:

Re: ISO 9001:2008 and Quality Manual

HAVING READ THROUGH SOME OF THE REPLIES TO YOUR MANUAL QUESTION. READ THROUGH THE MANUAL AGAINST THE DIFFERENCES FROM 9001 TO 9001:2008 TRANSITION. TO ENSURE ANY DIFFERENCES POSTED BY MOST CERTIFYING BODIES, ARE PICKED UP AND CRYSTAL CLEAR IN THE MANUAL, USE THE USUAL SIDELINING METHOD. ALSO MAKE SURE WHAT YOU SAY IN THE MANUAL ABOUT YOUR PROCESSES AND THE MODIFICATIONS YOU HAVE MADE IN THE MANUAL ALIGN IN THE SUPPORTING DOCUMENTED MANAGEMENT SYSTEM. OF COURSE THEN CONDUCT YOUR OWN iNTERNAL AUDIT TO TEST THE ARRANGEMENTS!

Re: ISO 9001:2008 and Quality Manual

samsung said:

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.

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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.

Re: ISO 9001:2008 and Quality Manual

As we know the knit picking often is generated by the CB. Your points are well made and valid

Re: ISO 9001:2008 and Quality Manual

PGTIPS8 said:

HAVING READ THROUGH SOME OF THE REPLIES TO YOUR MANUAL QUESTION. READ THROUGH THE MANUAL AGAINST THE DIFFERENCES FROM 9001 TO 9001:2008 TRANSITION. TO ENSURE ANY DIFFERENCES POSTED BY MOST CERTIFYING BODIES, ARE PICKED UP AND CRYSTAL CLEAR IN THE MANUAL, USE THE USUAL SIDELINING METHOD. ALSO MAKE SURE WHAT YOU SAY IN THE MANUAL ABOUT YOUR PROCESSES AND THE MODIFICATIONS YOU HAVE MADE IN THE MANUAL ALIGN IN THE SUPPORTING DOCUMENTED MANAGEMENT SYSTEM. OF COURSE THEN CONDUCT YOUR OWN iNTERNAL AUDIT TO TEST THE ARRANGEMENTS!

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This is the approach that I was taught as well. That an organization should look to see if the old wording may have contributed to misunderstandings on how to apply the standard and to make corrections in their documentation and practice as needed. Usually, little or none is needed.

My understanding is that 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.

Re: ISO 9001:2008 and Quality Manual

samsung said:

BTW, there are more than 65 changes.

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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.

Re: ISO 9001:2008 and Quality Manual

Helmut Jilling said:

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."

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A better approach is not to make any reference to the ISO 9001 standard whatsoever. There is no need for that.

Re: ISO 9001:2008 and Quality Manual

Sidney Vianna said:

A better approach is not to make any reference to the ISO 9001 standard whatsoever. There is no need for that.

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Perhaps, but most manuals have some kind of notation that it is based on and meets the requirements of ISO 9001, or TS-16949, or whatever. I think it is a good thing.

Re: ISO 9001:2008 and Quality Manual

Helmut Jilling said:

Perhaps, but most manuals have some kind of notation that it is based on and meets the requirements of ISO 9001, or TS-16949, or whatever. I think it is a good thing.

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A good thing how? I think a case can be made for it being harmful, as it supports the "ISO says so" way of thinking. At the very least it has the potential to create unnecessary effort, which we see here all the time. An entire compliant QMS can be built that's completely free from references to the standard, and I've always believed that if something can be eliminated without affecting outcomes, it should be eliminated.

Re: ISO 9001:2008 and Quality Manual

Jim Wynne said:

A good thing how? I think a case can be made for it being harmful, as it supports the "ISO says so" way of thinking. At the very least it has the potential to create unnecessary effort, which we see here all the time. An entire compliant QMS can be built that's completely free from references to the standard, and I've always believed that if something can be eliminated without affecting outcomes, it should be eliminated.

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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...