"Licensed" copy of ISO 9001 Standard During Audit - Has an Auditor Asked for Proof?

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G

Gert Sorensen

#12
I read one of Craig Cochrane's articles the other day. It adressed the essentials of audits, where he commented on the fact that audits should be about the serious issues and not about nit-picking. Isn't this just a case of that?? Seriously, we pay them to audit us, and this is what they bring up?! How is that for value added audits :applause:
 
S

S Roche Hendrix

#14
This has come up during both 9001 and 14001 audits. It was written up because it was not identified as a document of "external origin" and placed in our document control system. We had discussed it prior to the audit and decided that scanning it and placing an electronic scanned copy in our system; similar to how we handle other documents of external origin; would be a copyright issue.

We will maintain one "official" hard copy in our document control system but have no intention of controlling all copies on site since a copy is purchased for all of our internal auditors.

Where the "nit-picking" came into play was with the FDA Quality System Regulation. This was also mentioned in the finding. We have no intention of controlling any copy of this because it is available on the internet.

Susan
 
#15
What is a 'licensed copy'? Since the Organization for Standardization doesn't 'license' documents like ISO 9001, what was the auditor (or you) requiring??

If you are talking about having an original copy (hence the comments about 'the law', I guess) then, sure someone has to have the document. I would find it difficult to justify trying to design and implement a quality system without the ruling specification - be it ISO 9001, ISO/TS 16949 or something similar (sorry Randy, I think you're off base here, matey:notme: )

Indeed, a friend of mine (who's a registrar auditor) visited a company for a surveillance audit and found the MR hadn't ever seen ISO 9001:mg: Needless to say, basic practices weren't in place (but they were registered - don't ask who the registrar was!):lmao:

Andy
 
B

BHarvey

#16
Qualityalways,

It reads to me as a situation where the auditor would be going out of his scope, in my opinion.

What difference does it make if you have a documented receipt on hand as "proof" of whether or not you purchased the copy of the Standard?

If the auditor is expecting you to maintain copies of receipts from purchases then he is going beyond auditing and into dictating how your system should be. I think that the only time this would be valid would be if you had a statement in your document control procedure that said you would maintain proof of purchase for all documents, books, pencils, etc.

It seems like a situation where the auditor tries to give you a nonconformance because you didn't qualify Office Depot to be a supplier for #2 Pencils. Or maybe one wherein the auditor gives you a nonconformance because an employee was cleaning his keyboard but there was no documented procedure or training records to prove his competence to perform the task!
 

Randy

Super Moderator
#17
What is a 'licensed copy'? Since the Organization for Standardization doesn't 'license' documents like ISO 9001, what was the auditor (or you) requiring??

If you are talking about having an original copy (hence the comments about 'the law', I guess) then, sure someone has to have the document. I would find it difficult to justify trying to design and implement a quality system without the ruling specification - be it ISO 9001, ISO/TS 16949 or something similar (sorry Randy, I think you're off base here, matey:notme: )

Indeed, a friend of mine (who's a registrar auditor) visited a company for a surveillance audit and found the MR hadn't ever seen ISO 9001:mg: Needless to say, basic practices weren't in place (but they were registered - don't ask who the registrar was!):lmao:

Andy
You're wrong Andy...A well functioning QMS can be implemented and maintained never once referencing ISO 9001 or any other Quality Standard as long as the requirements are met. There are numerous QMS's in existance that are set up that way. The same holds true for ISO 14001 (EMS), OHSAS 18001 or ANSI Z-10 (OHSMS).

I originally received my EMS-LA status from the RAB having never conducted an audit to ISO 14001. How? Under an equivalent document that met all the same requirements (the ITT EHS Program Rev 1996). Numerous other auditors of various schemes got their respective credentials in similar fashion. I have personally audited for registration to ISO 14001 an organization that did not use or refer to it in their system, but they met the requirements and have the cert on the wall (this was for another Registrar and not my employer).

Is it common? Nope. But it can and has been done.
 
#18
I originally received my EMS-LA status from the RAB having never conducted an audit to ISO 14001. How? Under an equivalent document that met all the same requirements (the ITT EHS Program Rev 1996).
And what was the ITT EHS program based on? I rather doubt if a bunch of folks sat in splendid 'ISO-lation' of some pre-existing requirement.:nopity:

Randy, all these things started out somewhere - my experience was with NATO AQAP 1 and DEF-STAN 05-21 which were the precursors of ISO 9001, so c'mon, don't give me any cr*p;) ..........It's not a case of right or wrong or "my experience is more valid than yours"..........:notme:
:truce:
Andy
 

Randy

Super Moderator
#19
And what was the ITT EHS program based on? I rather doubt if a bunch of folks sat in splendid 'ISO-lation' of some pre-existing requirement.:nopity:

Randy, all these things started out somewhere - my experience was with NATO AQAP 1 and DEF-STAN 05-21 which were the precursors of ISO 9001, so c'mon, don't give me any cr*p;) ..........It's not a case of right or wrong or "my experience is more valid than yours"..........:notme:
:truce:
Andy

Actually Rev 1996 was based upon Rev 1994 and was followed by Rev 2000. The ITT EHS Program pre-dates 14001 by many years.

Systems are audited to criteria (hopefully you know that:rolleyes: ). If they meet the criteria, fine, if not, oh well. Where is it dictated that the criteria "MUST" be used to establish the system?
 

Ajit Basrur

Staff member
Admin
#20
Andy,

By "licensed copy", I meant the official copy of the standard which is issued under the Management Representative or somebody's name within the organisation.
 
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