Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:2008

Re: Updated Quality Manual for ISO 9001:2008

Colpart said:

Hmmm, I see where you are coming from but I am not sure I would want to raise a nonconformity just because people did things differently. Now, if the output of the process was different, that may be a problem.

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I belive that most of the time the output of a processes will have some variance if the same steps are no followed. Please note i said most of the time and not always.

Also, the very fact that the organistaion is implementing QMS, the objective is to establish the most appropriate process which will give the desired output and which needs to be followed by all individuals to ensure consistency in achieving targets.

Regards,

Re: Updated Quality Manual for ISO 9001:2008

Sidney Vianna said:

Jim, I don't think you are listening. The question about how many procedures or how many processes require a documented procedure ISO 9001 requires is totally irrelevant. I could have a single, lonely, procedure and that would be in compliance with ISO 9001.

Your public profile lists you as a consultant.

To me, your comments come across as someone that helps clients pass an audit, instead of assisting them in developing robust systems.

A good consultant should not see passing an audit as the criteria to judge the efficacy of the systems they help their clients with.

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Perhaps I should update my profile. I am both an auditor and a consultant.

As I have repeatedly stated, I do not prefer the approach and do not consult that it is a preferred approach. I strongly recommend against it.

As an auditor, I will not write a NCR for this on the face of it. It would certainly be an audit trail though.

Am I the only one that frequently sees only those six documented procedures? I see them very often.

Re: Updated Quality Manual for ISO 9001:2008

Jim Wynne said:

If I saw a manual that included or referenced only the six I would ask if there are other documented procedures, and if there were I would question why they weren't included which could lead to citing a nonconformity based on 4.4.2(b).



The requirement is in 4.4.2(b). It seems that you're going around the barn and out to the south 40 to avoid it.



You're advocating auditing to a very narrrow interpretation of a requirement that seems very clear to me. If the quality manual doesn't include or reference all of the documented procedures required by the QMS, it doesn't satisfy 4.4.2(b).



That interpretation has nothing to do with the question at hand. It asks if a system is in compliance if the documented procedures are included in the manual but not maintained separately from the manual. It says nothing about what documented procedures are required.

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What standard are you looking at? I can't find 4.4.2 in ISO 9001:2000.

Read what I said about the TC 176 intrepretation again. I said it does not address it directly. Read the TC 176 intrepretation again. What it does do is presuppose that you have the understanding that there are six required procedures to apply the answer they gave.

Re: Updated Quality Manual for ISO 9001:2008

maple1 said:

I believe that most of the time the output of a processes will have some variance if the same steps are no followed. Please note i said most of the time and not always.

Also, the very fact that the organization is implementing QMS, the objective is to establish the most appropriate process which will give the desired output and which needs to be followed by all individuals to ensure consistency in achieving targets.

Regards,

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I don't disagree, the point I am trying to make is that consistency of output is more important to me than the rigour of having to follow a set procedure. I quite agree that following a procedure should ensure the correct output.

My problem is that different people often do things in different ways and as long as they are competent to make that judgement and achieve the desired output I am not likely to be concerned. It does of course depend upon circumstances.

Re: Updated Quality Manual for ISO 9001:2008

Colpart said:

I don't disagree, the point I am trying to make is that consistency of output is more important to me than the rigour of having to follow a set procedure. I quite agree that following a procedure should ensure the correct output.

My problem is that different people often do things in different ways and as long as they are competent to make that judgement and achieve the desired output I am not likely to be concerned. It does of course depend upon circumstances.

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Exactly different people do things differently and still achieve the same output. What I am trying to state is that there will be one among them who is the best or some who do a specific part of the process chain most efficiently. As part of QMS, we need to decide and select the style of an individual who is the best or choose and combine the most appropriate steps.

Re: Updated Quality Manual for ISO 9001:2008

Big Jim said:

What standard are you looking at? I can't find 4.4.2 in ISO 9001:2000.

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I meant 4.2.2(b).

Big Jim said:

Read what I said about the TC 176 intrepretation again. I said it does not address it directly. Read the TC 176 intrepretation again. What it does do is presuppose that you have the understanding that there are six required procedures to apply the answer they gave.

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I also have the understanding that there are six specifically required documented procedures, but that doesn't mean that there will be no others that are not specified in the standard.

Re: Updated Quality Manual for ISO 9001:2008

Jim Wynne said:

I meant 4.2.2(b).



I also have the understanding that there are six specifically required documented procedures, but that doesn't mean that there will be no others that are not specified in the standard.

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Think about that for a moment. How can there be six specifically required and that there MUST be others?

Re: Updated Quality Manual for ISO 9001:2008

Big Jim said:

Am I the only one that frequently sees only those six documented procedures? I see them very often.

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I have never audited an organization which had only 6 documented procedures. It would be a major red flag for me, had I encountered the situation.

Big Jim said:

Think about that for a moment. How can there be six specifically required and that there MUST be others?

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4.2.1 General

Re: Updated Quality Manual for ISO 9001:2008

Big Jim said:

Think about that for a moment. How can there be six specifically required and that there MUST be others?

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Think about what "specifically" means in this context. There are six documented procedures that are specifically (explicitly) called out and there are any other ones needed for the operation of the QMS, as has been pointed out repeatedly.

Re: Updated Quality Manual for ISO 9001:2008

Big Jim said:

As I have repeatedly stated, I do not prefer the approach and do not consult that it is a preferred approach. I strongly recommend against it.

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This doesn't come through in most of what you've written in this thread. In fact, rather the reverse.

Big Jim said:

Am I the only one that frequently sees only those six documented procedures? I see them very often.

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What kinds of organisations are you auditing? In what fields? What sizes and types?

I can maybe believe a very very small organisation with a very, very low staff turnover and a very, very simple system (one process say) might have a very low need for written procedures. Or maybe perhaps an organisation with a very high degree of built-in IT/automation. Maybe. (But then, in the latter case, I'd see that the IT/automation was in fact instead of written procedures - ie, the procedure/process was defined and built-in.

But you're saying you see it frequently and very often.

I asked several auditors whose opinion I respect, and all found it quite an unusual idea, and agreed that they would (if they came across it) consider it definitely far from 'normal'.

Seems to me to be heading straight along the path of 'we know what we're doing, and once you've worked here for a while you'll know too', which isn't what I expect from a sound QMS.


This must be one of the most responded to topics, which has explored all kinds of directions and wandered far from the OPs query. Interesting.