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

Is not having a current copy of ISO9001:2000 a Nonconformance?

  • Yes

    Votes: 5 21.7%

  • No

    Votes: 18 78.3%
  • Total voters
    23
  • Poll closed .
A

AndyN

Moved On
#41
#41
Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

Coury Ferguson said:
In my opinion, I think we are missing the point.

The point is: There is no requirement to have a copy of ISO9001:2000, however, there is a requirement to control documents of an external nature.

We do not really have enough information to make a call. Was this the only document or were there others? That is the next question.
Click to expand...
So, it can't be a non-conformity, then...........:rolleyes:
 
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Coury Ferguson

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#42
#42
Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

AndyN said:
So, it can't be a non-conformity, then...........:rolleyes:
Click to expand...
Based upon the information provided, I would agree...there is no requirement. No requirement...No NC

I still would like an answer to my question though:


Coury Ferguson said:
Was this the only document or were there others?
Click to expand...
 
Randy

Randy

Super Moderator
#43
#43
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?
 
B

Bob the QE

#44
#44
Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

Just thinking out of the box...Let me offer this view just for food for thought, If I am the MR and thus am responsible for a) in 5.5.2 and me being the MR rep, inform the auditor that I periodically check my revision of the "uncontrolled" standard to a controlled version ( soem internet sight) for revision compliance, could it not be my point that my system is based and in accordance with the controlled version of the standard I thus meet the standard. The fact that the copy I have is not original or controlled is irrelevant if I meet the standard, yes or no. What if I was some sort of system prodigy and I could recite the standard word for word (including notes) and our system meets the standard, do I need to be controlled ( I know I am not a document at least on the outside).....:rolleyes:
 
Randy

Randy

Super Moderator
#45
#45
Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

If a person could cite a contract to design and build something word for word would that be acceptable instead of actually having a copy?
 
Coury Ferguson

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#46
#46
Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

Randy said:
If a person could cite a contract to design and build something word for word would that be acceptable instead of actually having a copy?
Click to expand...
That is a whole different scenario. That would fall under design (Apples and oranges here).
 
D

Doug Tropf

Quite Involved in Discussions
#49
#49
Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

We include verifying that we are up to speed on the latest applicable standards as one of our management review inputs. This is to address (in our case) the requirements of 13485 5.6.2(f) "changes that could affect the quality management system". There is also a related clause requiring management review of new or revised regulatory requirements.

I voted that the situation described in the OP is a non-conformance.
 
P

Peter West

#50
#50
Re: Not having an original copy of ISO 9001 standard, Is it a Non- Conformance?

I think the poll is misleading to actual topic of the thread. The nonconformance is correct as it applies to whether there are sufficient controls in place on external documentation.

As far as the poll is concerned - you need to know the Standard down to the letter (or at least be aware of it). You need to know of any new parts, changes etc. BUT as far as i can see there is no part that says you must sit there with a gold plated copy of the Standard in your hand. You have to use it, refer to it, read it, eat it, sleep it...but why not just go to the library every day and pick it up use it then go back home...

My point is that actually having a tangible copy is definitely useful (I am looking at mine right now) but as long as the most current version of the Standard is used in application by the Company what does it matter if you have the document? It is the system that matters not the paper.
 
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