Is not having a controlled copy of ISO 9001 standard a NonConformance?

[BradM]

Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

I would like to post the real statement in the NCR issued by the Auditor:

"Internal Audits are found to be carried out without referring to the approved (licensed) copy of the ISO Standard. Also, it is found that ISO and all international standards like ASMI,ASTM Codes are listed by the organisation as external documents which has to be controlled as per the document control procedure. However, Internal Auditors were found to be carried out the audits with respect to current version of ISO Standards but with uncontrolled copy"

Here is the verbal explanation given by the auditor during closing meeting :

" Since,the organisation is using uncontrolled copy of ISO Standard for auditing the QMS,it shows it wont be updated if the new revision comes in the future" Also, the system fails to control the documents of external orgin. He defined the standard as a quality record which should be maintained as a controlled copy. This is a Minor Non conformance.

This, IMHO, is not a citation against a standard. This is an observation, and a weak one at that. The external auditor should be about the business of assuring proper processes, and not policing every moral/legal issue one may see.

Exactly what Sidney alluded to earlier rings with me. The auditor should be careful of throwing rocks in Glass Houses.

NOTE: I am not saying it's OK to have copies. The organization needs to have purchase a legitimate copy of the standard. But that is an observation to be issued to top management, not a non-conformity of the system.

 

[Jim Wynne]

Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

9001 is not called for by name, it's just another requirement that must be used for effective planning the same as a contract or customer request would.

You wouldn't design and build a product without a copy of the specs would you?

I'm going to make one more observation here, and then let this thread go.
I would/could not design and build a product without a copy of the specs, but it's a weak analogy. I did my first ISO 9001 registration process some 16-17 years ago. Since then I've also guided registration efforts in later versions of the standard, as well as QS9000. Today, I could lead a registration process from gap analysis to certification without looking at a copy of the standard (ISO 9001-2000) even once. I'm not unique--there are lots of people with similar experience and knowledge.

Saying that references in the standard to the QMS needing to be in compliance with the standard are in no way related to the question of whether there is a mandatory requirement for "the organization" to be able to produce a copy of the standard at an auditor's request.

 

[AndyN]

Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

I'm going to make one more observation here, and then let this thread go.
I would/could not design and build a product without a copy of the specs, but it's a weak analogy. I did my first ISO 9001 registration process some 16-17 years ago. Since then I've also guided registration efforts in later versions of the standard, as well as QS9000. Today, I could lead a registration process from gap analysis to certification without looking at a copy of the standard (ISO 9001-2000) even once. I'm not unique--there are lots of people with similar experience and knowledge.

Saying that references in the standard to the QMS needing to be in compliance with the standard are in no way related to the question of whether there is a mandatory requirement for "the organization" to be able to produce a copy of the standard at an auditor's request.

It's only a weak analogy - from your point of view! I've used the analogy with countless clients, and the feedback I get (from them) is that it's a no-nonsense, clear and helpful description!

I'd suggest that too many people (and it's demonstrated here in this very thread as well as countless others) THINK they know the spec. To the vast majority of visitors here at the Cove, it is dangerous to read the postings of a (small) number of (self- proclaimed) experts who postulate that it's unnecessary to have a copy of the standard to be incompliance with it!

It is foolhardy to speak of hypothetical situations, when most of us are faced with the practical reality of implementation! I believe that's the reason many people are here - for practical implementation assistance/advice/sharing - not to endlessly debate what 'could be'! Hey, but that's just me!

BTW - I totally agree with your second point

 

[Al Rosen]

Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

Then what?

​

Maybe it's a stretch, but management may not have communicated the importance of meeting statutory requirements.

 

[Jim Wynne]

Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

I'd suggest that too many people (and it's demonstrated here in this very thread as well as countless others) THINK they know the spec. To the vast majority of visitors here at the Cove, it is dangerous to read the postings of a (small) number of (self- proclaimed) experts who postulate that it's unnecessary to have a copy of the standard to be incompliance with it!

Many people come here because they're unsure about what the standard means in specific instances, and they invariably get good advice and things to think about from people who feel confident enough in their knowledge and experience to offer advice. If there's any danger in following advice gleaned from public forums, surely the responsibility for implementing the advice (or not implementing it) rests with the person doing the implementing.

The whole discussion is theoretical, as the likelihood of any registered company intentionally not having a copy of the standard is negligible. I do not advocate setting fire to the standard, or otherwise not having a copy of it, and anyone who thinks that I have advocated it in this thread is mistaken.

 

[Paul Simpson]

Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

I am astounded by the amount of bits and bytes wasted spent on this discussion. In itself, the situation is a technicality. For some, this trivial, inconsequential issue will raise to a non-conformity. For others, it is a non-issue.​

Bad week, Sidney? If we added up the words (pixels?) on this site that added no value (in the opinion of the viewer!) we would definitely give up and go home. The point of this and any other thread is to test understanding and challenge preconceptions.

FWIW I grew up with my first CB obeying the rules and issuing NCs for:

• the company not having copies of ISO (even though their systems were compliant
• Quality policy not signed
• Etc., etc.

After a while I learned to think for myself and challenge some of the preconceptions. Visitors to the cove are fortunate enough to be able to read your postings and those of others and get to be ahead of the game in a much shorter time than it took me to learn by experience.

So I say let battle recommence!

 

[Randy]

Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

Like I've said...I have never asked because there are many more important things to find out during an audit like "What's for lunch?"

 

[Jim Wynne]

Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

Like I've said...I have never asked because there are many more important things to find out during an audit like "What's for lunch?"

It's good to have priorities in order!

 

[Peter West]

Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

I dont come from a Quality background so to be able to use this site (community for want of a better word) to confirm or allay any fears/questions i have (especially in light of the fact they relate to actual work) is INVALUABLE. I really would be stuck if it wasnt for this Cove (and i'm only 3 months into the job)!!!



Although i take most of the information on here as very well informed - i do not count it all as gospel. I am the only one responsible for implementing something i pick up here into my office.

 

[Sidney Vianna]

Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

Maybe it's a stretch, but management may not have communicated the importance of meeting statutory requirements.

I do believe that this is a very long stretch because, in the context of ISO 9001, statutory requirements relate to product.

If CB auditors were to turn into copyright patrol cops, what would stop them from delving into other issues, such as SOX compliance, American with disabilities Act, etc?