Definition Evidence of Conformity - Interpretation of ISO 9001 Clause 8.2.4 (data - yes or no?)

G

glfmd56

#1
I have a question regarding the interpretation of "evidence of conformity" and to waht level of evidence is required.

Having been through many internal and external ISO-9001, TS-16949, AS-9100 audits over the years, my question is; what consistutes as evidence of conformity within an inspection record. I have seen companies simply use a "check" mark to the actual recording of data for product features.

I for one have always believed that this type of evidence should be in the form of data in order to verify product requirements have been met. In addition, it makes sense from a business standpoint for trend analysis. Any thoughts would surly be approciated.

:argue:
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Evidence of Conformity - Interpretation of ISO 9001 Clause 8.2.4 (data - yes or n

Any feedback on this folks?
 
Q

qualitymanager

#3
Re: Evidence of Conformity - Interpretation of ISO 9001 Clause 8.2.4 (data - yes or n

I'll answer at 2 levels and try not to raise Stiljoor's blood pressure :p

Compliance: If the requirement says "evidence of conformity" - then the company decides (and the Registrar accepts, or not) how it does this. It could be a check mark, a "Passed" stamp or anything else.

Remember - ISO 9001 gives minimum requirements.

Beyond minimal compliance: Sure - you can have detailed stats. And they will be very useful in trend analysis (and Preventive Action, etc.) But remember to consider the people doing the checks - are they comfortable with the type of inspection/measurement/analysis required, or will they balk at the complexity of tasks involved?
 

Big Jim

Super Moderator
#4
Re: Evidence of Conformity - Interpretation of ISO 9001 Clause 8.2.4 (data - yes or n

I'll answer at 2 levels and try not to raise Stiljoor's blood pressure :p

Compliance: If the requirement says "evidence of conformity" - then the company decides (and the Registrar accepts, or not) how it does this. It could be a check mark, a "Passed" stamp or anything else.

Remember - ISO 9001 gives minimum requirements.

Beyond minimal compliance: Sure - you can have detailed stats. And they will be very useful in trend analysis (and Preventive Action, etc.) But remember to consider the people doing the checks - are they comfortable with the type of inspection/measurement/analysis required, or will they balk at the complexity of tasks involved?
I believe this is correct. In the absence of a stiffer customer requirement, all that is needed is acknowledgment that the spec has been met, and all that is needed is a stamp, yes, check mark, initials, signature, etc. according to your company's own protocol.
 

Stijloor

Staff member
Super Moderator
#5
Re: Evidence of Conformity - Interpretation of ISO 9001 Clause 8.2.4 (data - yes or n

<snip>I'll answer at 2 levels and try not to raise Stijloor's blood pressure
I appreciate your concern about my health... But no, my blood pressure is in control.

Stijloor.
 
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