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An uncontrolled record is it a non-conformance?

G

Golfman25

Trusted Information Resource
#11
#11
qualprod said:
Thanks Big Jim.
What I post is the case I have, and want hear your opinion, regarding if such evidence(record) should be included into the list if documents/records or could be outside of the Qms (no control)
Thanks
Thanks
Click to expand...
As stated previously, a record doesn't have to be on a list to be controlled. Take for instance purchase orders. Most are computer generated these days and can contain all sorts of pertinent information. It's a controlled record if it is filed and maintained in an orderly fashion (or even kept electronically). Don't have to put it on any master list or anything.

So the answer to your question is, yes a record needs to be controlled, but does not have to be included into the "list of documents/records."
 
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B

Big Jim

Super Moderator
#12
#12
qualprod said:
Thanks Big Jim.
What I post is the case I have, and want hear your opinion, regarding if such evidence(record) should be included into the list if documents/records or could be outside of the Qms (no control)
Thanks
Thanks
Click to expand...
So it appears that there is no specific nonconformance, but that this is a theoretical question.

OK, others have mentioned it. Control of documented information is covered in 7.5. What you used to know as records are now referred to as retained documented information. Besides the general rules to control documented information in 7.5, there are 30 places (by my count) where the standard tells you that you need to retain documented information.

Read 7.5 carefully. Read A.6 in the Appendix thoroughly. If that still leaves you wondering how to handle a record, then look for the specific element in the standard for that topic.

And don't forget that if you decide to keep additional records besides the specific 30 mentioned in the standard that you have to obey the rules from 7.5 with them too.
 
R

r1ch481

#13
#13
My answer to this is.. If a document is to be used as evidence to comply with the requirements of ISO 9001 then it SHALL be controlled. (with doc. no. revision and date) So NC can only be raised against these documents which serves as evidence of implementation.
 
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