I have to CITE the ISO clause in BOTH my Quality Manual and in department procedures?

[Ace]

Help!!!
I am having a hard time finding a reference in ISO 9K2K that states I have to document the ISO clause in both my Quality Manual and also in department procedures. Example: My quality manual states the following ISO requirement for clause 8.2.2 - "The audit program is planned and takes into consideration the staus and importance of the processes and areas to be audited, as well as the results of the previous audits". My internal audit procedure defines only our process and does not repeat the above section.
Our ISO registrar states that I am required to document the ISO clause in both my manual and procedures. Confused as to why this is needed in both places. Thank you in advance for your professional advice.

[Teri]

I would ask the regristrar where this requirement is.
Are you sure that they are saying you must have the clause in both places?

I have the clause in my manual, however my procedure states how I meet the clause, it does not contain the clause though.

[RCBeyette]

Like Teri, I address the Clause in my Quality Manual, but get into specifics in my lower level documentation. Is your Registrar, perhaps, looking for a definitive link between the levels of documents? In my Quality Manual, in the Audit section, I reference the associated documentation detailing how audits are scheduled, conducted, etc. And in those documents, I reference back up to the Quality Manual.

[Graeme]

I agree with Teri -- ask the auditor or registrar to show you where the "shall" is.


This is the sort of thing a document matrix -- or a good web page on the internal network -- is supposed to take care of:

• show the relationship of the Quality Manual to the Standard, and then
• show the relationship of the policies/procedures/forms/records to the Quality Manual.

(Of course, they may be asking for it for their own convenience which is a completely different issue...)

[apestate]

Ace

Be sure and clarify what the auditor is asking for. Are you in the document review/bench audit stage? Make very sure, as has been stated by the other responders, that she/he's not just asking for a statement of scope or reference to manual in the procedure.

Registrar auditors work very close to the standard and sometimes aren't the best at communicating otherwise simple concepts because of the nature of their involvement.

There is a standard for writing procedures, but nothing in ISO 9001-01 about that. You'll be looking for a while. I think ISO drafted a 10013 that talks about documenting, table of contents structure and format sort of thing.

As far as ISO 9001 is concerned, you could make the documents any way you wanted, even video could be a QMS procedure, or a flowchart

This sounds more like a suggestion to me. choose your battles.

[Ace]

Thanks to all for your feedback.
FYI - In my Quality Manual I referenced the Int. Audit procedure, and in the procedure, I referenced the Quality Manual. I pointed this out to the auditor and he still said I had to state the requirement in both places. When I asked him for the reference he stated 8.2.2, and wrote a non-conformance against it.

[Teri]

I would personally argue that one.

[Al Rosen]

Ace,

Although the auditor is wrong. If this is the only place he has cited you for this, it is easier to acquiesce then to fight him otherwise formally challenge it. You don't want to have to revise all your procedures and manual. BTW, If you haven't referenced the clause within your procedures, why is this the only place he dinged you?