Process capability analysis in ISO 9001:2015

JOSEG

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#1
I have a question in regards to ISO 9001:2015. I was told that process capability analysis for the use of process control is implicit in ISO 9001:2015, specifically on sections 8.1 and 8.4. Please let me know what you think.
 
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John C. Abnet

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#2
Good day @JOSEG ;

No.
(this is not what I or anyone else thinks. This is simply not a requirement. )

There is little (none?) "implicit' in 9001 or other international standards. The standards (particularly 9001) do a pretty good job (I'll exclude 16949 from this praise) at clearly identifying what is "shall" or otherwise.

Don't read beyond what the standard requires....even if an auditor says "it's implied".

Hope this helps.

Be well.
 
#3
I don't see anything in production planning (8.1) or purchasing (8.4) that would substantiate such a position. Really, the main place it shows up is 4.4.1 c "determine and apply the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes".

What you quoted looks like interpretation drift.
 
#4
I was told that process capability analysis for the use of process control is implicit in ISO 9001:2015,
Who said this? It really depends on if that person is competent in Quality, Quality Management etc. We hear people say "risk" has always been implicit in ISO 9001 and everyone's got a different opinion, based on their knowledge, experience and skills. I could offer a valid reason why process capability IS implicit in ISO 9001...
 
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