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

liuyy

Involved In Discussions
#11
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.
 
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David Hartman

#12
liuyy said:
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:
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#13
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.
 
Last edited:
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Greg B

#14
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
 

The Taz!

Quite Involved in Discussions
#15
Claes Gefvenberg said:
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
 
S

stbushmen

#16
Re: I have to CITE the ISO clause in BOTH my Quality Manual and in department procedu

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?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#17
Re: I have to CITE the ISO clause in BOTH my Quality Manual and in department procedu

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.
 
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