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

[Sidney Vianna]

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

How would an auditor asking for our copy of the Standard view that?

As you can tell by the diversity of opinions, there is no way to predict how an auditor would see your situation. Some probably would not even bother to ask you about it. Others might issue you a MAJOR non-conformity.

Some auditors believe they have been invested as ISO-cops. But, if this is their take on value added audits, I feel sorry for both of you.

 

[Randy]

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

I'm simply saying that there is no explicit requirement to have a copy.

You're correct

Implicit requirements are subject to personal interpretation, and that's not a good place for external auditors to go.

I never interpret...ask around....and as for places that wouldn't be good for an external to go....I'll leave this unsaid


I know where your going and to tell the truth I don't think I've asked if anyone has a copy of the standard in any audit I've done because folks normally have been cognizant enough to have their own copy and it wasn't that high on my list of priorities of the things to be concerned about. I'm concerned with the real deal stuff.

 

[AndyN]

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

I'd suggest that not only is a copy required - as design criteria for the system originally - but to ensure (compliant) maintenance of the system as it develops. I have been to organizations who have allowed their systems to 'go off the rails', and without the same (original) design criteria available, that deviation from the original intent would be difficult to detect.

Using my analogy, I rather doubt that once a company had designed its product and released it into manufacturing etc., that the design function would torch the drawings or the criteria used to guide the design.

I'm afraid that Jim's hypothesis won't cut it in real life...........well, maybe in Wisconsin it will......

 

[Jim Wynne]

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

I'd suggest that not only is a copy required - as design criteria for the system originally - but to ensure (compliant) maintenance of the system as it develops.

Great--show me the "shall."

 

[Randy]

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

Great--show me the "shall."

4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. Show me the requirements...


4.2.1 General
The quality management system documentation shall include…d) documents needed by the organization to ensure the effective planning, operation and control of its processes,How can the QMS be planned without the necessary document to do so? If you don't know what it is, how do you know you've done it?



4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. ISO 9001 is a record that provides the evidence of what the requirements of a QMS established to it are.



ISO 9001 is no different from any other requirement an organization must meet customer or otherwise that can have an effect upon product conformity or customer satisfaction (Let's not even play the silly "It's voluntary game")...Show me what it is and show me how you have met it.

 

[Paul Simpson]

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

In the hypothetical situation, I specified that all requirements have been met. It doesn't matter how it gets done, so long as it does get done.

I agree with Jim. I answered this question elsewhere when discussing changes to the latest edition (2008). IMHO there is no specific requirement that states an organization that invites you in to assess their QMS against a standard has to have a copy of the standard.

Perhaps if people spent more time looking at the spirit of the requirements rather than the letter of the document we would have better systems?

Mind you, I realize that having a copy of the standard is a good thing, and I'm not adovocating setting fire to them. I'm simply saying that there is no explicit requirement to have a copy. Implicit requirements are subject to personal interpretation, and that's not a good place for external auditors to go.

Again agreed. (This must be a record! ).

Speaking for myself I would always want a copy of the standard to read it and understand the requirements and I am always more confident at the start of an assessment if the MR has a well thumbed copy of the standard - with notes in the margins!

 

[eternal_atlas]

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

My answer is no.

Depending on the scope of the audit, I question whether the auditor needed to be worried about the originality of the standard. That seems to be a little of a policing action.

If the answer is yes, then is the auditor licensed to perform more fishing expeditions? What about the software used for all the applications?

Until the standard has a specific clause to address "having an original copy of the standard (with a receipt of purchase), then I would challenge the finding.

Why spend $$$$ on the rest of the program, and not have the source document for it all? I would purchase the standard.

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.
Please comment on his statement,

But,as an auditee,i feel it is a nit picking excercise.. but i agree that i didnt control the iso standard since it is a document of external orgin,

 

[JaneB]

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

External Auditor issued a NC for not having the original standards of ISO9001:2000 with us. We have only uncontrolled copy of the standard.

My question is :

which clause address this requirement?

It's 4.2.3 e) (actually, the Auditor should have referenced that clause in the NC).

If you are seriously expecting/wanting certification to ISO 9001, it is a reasonable expectation that you should have a current copy of the current Standard. And your Document Control procedure should cover how you control documents of external origin, such as the Standard.

 

[Peter West]

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

" 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.

But,as an auditee,i feel it is a nit picking excercise.. but i agree that i didnt control the iso standard since it is a document of external orgin,

In light of the above comments i think it is clear that he is assessing they system and its management of external documents, and not specifically just the copy of the Standard. I suppose as an external auditor it is his/her perogative to approach the situation thinking - "if this has already happened with one document, what other parts of the QMS (what other documents) could it be affecting?" IMO its right to raise it as an NC.

I assume it is always well publicised when a Standard is changing but if for whatever reason this doesn't reach you, and there is no firm control on external documents, you would continue to use an out of date version of the Standard making your system 9001 non-conforming.

My opinion only

 

[Ajit Basrur]

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

Hi Suresh,

Going by the minor NC and the explanation of the auditor, I feel he is right.