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. :confused: Thank you in advance for your professional advice.

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.

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.

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...)

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.

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.

I would personally argue that one. :argue:

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?

no reason to put 8.2.2 in your procedure. logically it doesn't even make sense, you want that ISO garble out of your procedures, taken care of by the quality manual so your procedures can take care of the actual doing, be used by employees who may never have heard of ISO 9000...

we're all using ISO 9001 for quality management, control, and continual improvement. the system will be constantly developed throughout its own use, and the relationship with the auditor becomes not one of right/wrong but of continual effort.

basically what I'm trying to say is don't take it personally, but argue your case because this is your quality management system. you want a registrar auditor who will do the job right or you want to (7.4.1) re-evaluate your audit supplier.

if he said that of your audit procedure, what did he say about the other procedures? did he find that they restated the standard in their content? what's different about internal audit

When I asked him for the reference he stated 8.2.2, and wrote a non-conformance against it.Well Ace, you've already had your answer. I can only agree. It's hardly surprising that you are having a hard time finding a reference, considering the fact that it's not there. There is nothing in the standard requiring you to do what he's asking for. He's plain wrong, and personally I would not accept an audit report with that NC in it. Not a chance. It is not in the standard, nor will it add value to anything.

The only possible reason to do it would be to aid an auditor, but the written procedures are not there for the auditor. They are intended for the users.

/Claes

Requirements in ISO 9001 are what you must do.Your manual must answer the 3 requirments of clause 4.2.2.Your QMS procedures must specify how to do to meet the requirments of ISO 9001.You needn't to reference the clauses in your QMS ducumentation.

Requirements in ISO 9001 are what you must do.Your manual must answer the 3 requirments of clause 4.2.2.Your QMS procedures must specify how to do to meet the requirments of ISO 9001.You needn't to reference the clauses in your QMS ducumentation.

I agree with liuyy. There is NOT a requirement to include, or reference, the specific ISO clauses in either your QM or your procedures. The ONLY possible requirement for reference to clauses is that you must note any "exclusions" you may have to the requirements.

I would argue this one, since the ramifications may result in you having to spend time and money reviewing ALL of your documentation for this "requirement".
:2cents:

I totally agree. I too pick and choose my battles and I would definitely fight this one. I would not go through all of the hassle of revising all of my documents if I didn't think it benefited the user(s) - that's probably why there isn't a shall in the standard, who benefits from this?

On a side note, AS9100 and FAA requirements soon to be applicable to us do require this (Quote: AS9100 4.2.2b - when referencing the documented procedures, the relationship between the requirements of this International Standard and the documented procedures shall be clearly shown) - so even though I think this benefits the auditor, not the user of the document - I'm creating a matrix. THERE IS A SHALL!

Other people use their document numbering system to show relation to the element or clause, though I've never been fond of this method because standards are restructured and element/clause numbering revised, some procedures/processes fall under numerous elements, etc. In our particular case, I'm creating a matrix because we will be compliant with and need to show the relationship to numerous standards and regulations.

Just some thoughts.

Ace,

These are the battles I love to have with registrars. It is not stated anywhere so tell them to take a leap. :mad:
I do not have ANY references to ISO9001:2000, anywhere. They are NOT in my Policy or Manual and definately NOT in my Procedures. I do not have a Matrix although I did a while back until I realised that noone required it as it was a tool I used while I was doing the changeover to 9K2K and was no longer required.
IMO References or a Matrix just make it easier for the registrar to do a Desk Top Audit. Noone in my company really care if the CAPA procedure states 8.5.2 and 8.5.3 - They just need to know how to fill out a CAR.
The registrar should be asking 'questions' to people and have them show him/her where the documents are or how they comply with such and such.

Change registrars and remember they WORK for YOU. I sacked a Registrar years ago over a very similar stance.

Greg B

Not a chance. It is not in the standard, nor will it add value to anything.

The only possible reason to do it would be to aid an auditor, but the written procedures are not there for the auditor. They are intended for the users.

/Claes


We're in agreement again Brother!

Ace,

This is one battle I think I'd choose to fight. JMHO

I totally agree. I too pick and choose my battles and I would definitely fight this one. I would not go through all of the hassle of revising all of my documents if I didn't think it benefited the user(s) - that's probably why there isn't a shall in the standard, who benefits from this?

On a side note, AS9100 and FAA requirements soon to be applicable to us do require this (Quote: AS9100 4.2.2b - when referencing the documented procedures, the relationship between the requirements of this International Standard and the documented procedures shall be clearly shown) - so even though I think this benefits the auditor, not the user of the document - I'm creating a matrix. THERE IS A SHALL!

Other people use their document numbering system to show relation to the element or clause, though I've never been fond of this method because standards are restructured and element/clause numbering revised, some procedures/processes fall under numerous elements, etc. In our particular case, I'm creating a matrix because we will be compliant with and need to show the relationship to numerous standards and regulations.

Just some thoughts.


Cari,
Were you sucessful in testing your Matrix against an audit for compliance to the AS9100 standard? Just curious how the auditor viewed your fix?

Ace,

These are the battles I love to have with registrars. I sorta agree, but as a consideration, I would look to the specific auditor before slapping the registrar. I've never known a registrar that didn't get a batty auditor from time to time.