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

[maple1]

In Reply to Parent Post by Colpart

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.

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,

[Big Jim]

In Reply to Parent Post by Sidney Vianna

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.

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.

[Big Jim]

In Reply to Parent Post by Jim Wynne

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.

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.

[Colin]

In Reply to Parent Post by maple1

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,

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.

[maple1]

In Reply to Parent Post by Colpart

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.

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.

[Jim Wynne]

In Reply to Parent Post by Big Jim

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

I meant 4.2.2(b).

In Reply to Parent Post by Big Jim

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.

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.

[Big Jim]

In Reply to Parent Post by Jim Wynne

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.

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

[Sidney Vianna]

In Reply to Parent Post by Big Jim

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

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.

In Reply to Parent Post by Big Jim

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

4.2.1 General

The quality management system documentation shall include

d) documents needed by the organization to ensure the effective planning, operation and control of its processes