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

[Patricia Ravanello]

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

I was one of the folks who didn't see this a non-conformance so unless the auditor could sight rhyme and verse I am not worrying about it.

This requirement to be in possession of a copy of the applicable standard is implicit in the design and creation of a compliant system.

If you have (or even if you don't have) comprehensive flow charts, you would still have had to identify the standard as an "input" to your Operating System design and also, as input to the Internal Audit process (all your auditors need to be able to cite which clauses are involved in any non-conformance). As such, you are obliged to provide evidence of that input, and the auditor should be able to verify that you are in fact, using the latest revision level of the standard.

The same applies to "Customer specifications" which might be identified as "input" to your "product design process". As such, you would be obliged to provide evidence of that "required input" defined in your process.

Consider the standard as the "specifications" which define your System. There's no doubt that you need to be in possession of a current original document (unless you have ISO permission to create or distribute reproductions).

No doubt there are considerably bigger fish to fry in terms of audit focus...so why waste our energies on this rhetoric...just do it!

Patricia

P.S...By the way...what do you use (or what did you use, to create your system), if you don't have an original copy? Did you take one out from the local library?

 

[Stijloor]

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

We mark all of our publications "For Reference Only". Does that get us our of the duty to provide a current copy of the standard?

Andy mentioned "For Reference Only" threads. There are indeed quite a few.

Here is one for your enjoyment...

Stijloor.

 

[Jim Wynne]

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

This requirement to be in possession of a copy of the applicable standard is implicit in the design and creation of a compliant system.

If you have (or even if you don't have) comprehensive flow charts, you would still have had to identify the standard as an "input" to your Operating System design and also, as input to the Internal Audit process (all your auditors need to be able to cite which clauses are involved in any non-conformance).

I disagree. Once we start allowing for "implicit" (read: subjective) "requirements," the door's open for almost anything. Also, I do not have to cite the standard as input to anything--I don't have to mention it in my documentation, and my internal auditors don't need to even know that ISO 9001 exists--so long as my system is properly designed and documented.

 

[Patricia Ravanello]

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

--I don't have to mention it in my documentation, and my internal auditors don't need to even know that ISO 9001 exists--so long as my system is properly designed and documented.

...So how would you verify and validate that the system is properly designed and documented without using the Standard?

Patricia

 

[tyker]

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

Last year, I was involved in a TS16949 assessment, in mainland Europe, where one of the CB audit team members didn't bring a copy of TS or any of the core tool books with him. He claimed to have memorised all the requirements and could quote all the sub clause numbers accurately. Methinks he would have had difficulty citing us for not having a copy of the standard.

He was a dreadful auditor though and didn't quite get the message that knowing the clause numbers is not the same as knowing, and understanding, the contents of the clause.

 

[Jim Wynne]

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

...So how would you verify and validate that the system is properly designed and documented without using the Standard?

Patricia

The original question pertained to a finding by an auditor that the auditee had no "original" copy of the standard. The question evolved into whether there is a requirement in the standard to have copy of the standard. My contention is that so long as the system as a whole is compliant, an auditor shouldn't be concerned with whether there's a copy of the standard in evidence or not.

As I said in an earlier post, I've been dealing with ISO standards and registration processes for for ~18 years. I know what the requirements are. I'm sure you do too. I do not advocate being without a copy of the standard, and I think there are very few registered companies that don't have one, so the question is largely academic.

I think it's funny that on the one hand, when we hear people complaining about ISO 9001 compliance being a burden, someone always says that the standard doesn't ask for anything extraordinary--it's all stuff that well-run companies should be doing anyway. Now, when a question comes up about whether it's necessary to have a copy on hand, the standard is suddenly very complex and mystifying, and not "common sense" at all.
Let's get our stories straight.

 

[Patricia Ravanello]

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

Last year, I was involved in a TS16949 assessment, in mainland Europe, where one of the CB audit team members didn't bring a copy of TS or any of the core tool books with him. He claimed to have memorised all the requirements and could quote all the sub clause numbers accurately. Methinks he would have had difficulty citing us for not having a copy of the standard.

He was a dreadful auditor though and didn't quite get the message that knowing the clause numbers is not the same as knowing, and understanding, the contents of the clause.

Two wrongs don't make a right...Just because he didn't bring a copy with him, doesn't mean he didn't have one, or that you don't need one.

Why wouldn't you have a copy? What did you use when you designed and documented your system?
Did your management team never ask..."Show me where it says that we have to do that?...."
When you conducted internal training to introduce the standard and the system, did you never pull out the book?
Do all of your internal auditors have the sub-clauses and their contents committed to memory? ​

Not having a copy of the standard is like saying you don't need your "Bill of Materials' after you've designed and created a new product...

I'm just curious...why so adamant and/or defensive about not having a copy (not just Tyker...anyone???)

Patricia

 

[tyker]

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

I'm just curious...why so adamant and/or defensive about not having a copy (not just Tyker...anyone???)

Patricia

I'm not particularly defensive. I do have an up to date, official, paid for copy of all the standards I use and I don't attempt to justify not having one. Frankly, I don't think it really matters in most cases and I don't think it's a valid or value adding nonconformity for a CB to raise.

In the example I quoted, the auditor desperately needed a copy because he was up against an argumentative [email protected][email protected] (me) and couldn't justify many of the points he was trying to make, especially as I refused to lend him mine.

 

[Bob the QE]

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

My point was simply that a "copy" as long as it is the latest revision is OK. How you obtain it may raise other questions but if I can show revision control on my "copy" I would argue only that it is not a finding.

End of my story and I am off to catch those bigger fish I want to fry...

Thanks to all

 

[Coury Ferguson]

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

Two wrongs don't make a right...Just because he didn't bring a copy with him, doesn't mean he didn't have one, or that you don't need one.

Why wouldn't you have a copy? What did you use when you designed and documented your system?
Did your management team never ask..."Show me where it says that we have to do that?...."
When you conducted internal training to introduce the standard and the system, did you never pull out the book?
Do all of your internal auditors have the sub-clauses and their contents committed to memory? ​

Not having a copy of the standard is like saying you don't need your "Bill of Materials' after you've designed and created a new product...

I'm just curious...why so adamant and/or defensive about not having a copy (not just Tyker...anyone???)

Patricia

The fact is that a Nonconformance was issued because he didn't have a "Controlled Copy" not that he didn't have a copy.

We are talking Apples and Oranges here. He has a copy of the Standard. But there should not have been a NC issued for not having a "controlled copy."

Yes it is a good idea to have a copy of the standard, but there is no requirement in ISO9001:200x that I can see that you must (shall) have a controlled copy or copy as I see it. An Audit should be cost value added, not just gotcha (and unecesaary).

Just my humble opinion here.