ISO 17025 4.12: "...potential sources of nonconformities...shall be identified."

Stijloor

Staff member
Super Moderator
#11
Not the same as in 17025.

In 9001 they ask to write up an action which will be used to deal when potential nonconformities are spotted.

While in 17025 they ask to write up a list of sources of NC up front.
I understand the scopes of ISO 17025 and ISO 9001 very well; the main intent is to effectively deal with potential nonconformities.

I emphasize intent and do want to get wrapped up in semantics.

Stijloor.
 
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Jim Wynne

Staff member
Admin
#13
Not the same as in 17025.

In 9001 they ask to write up an action which will be used to deal when potential nonconformities are spotted.

While in 17025 they ask to write up a list of sources of NC up front.
"They" don't ask you to "write up" anything in 9001. They ask you to determine potential sources of nonconformity. For reasons I can't fathom, ISO has decided that "determine" is better than "identify," (while what they want you to do hasn't changed) but "determine" doesn't mean "record."

As to the original issue, if an auditor says that you must list potential sources of NCs in a 9001 quality manual, she's wrong. What you do have to show is evidence of efforts to prevent nonconformities, and as others have pointed out, some form ofconscientious FMEA process (not necessarily the automotive variety) will usually suffice.
 
L

lucasso

#14
identify
establish or indicate who or what (someone or something) is;
recognize or distinguish (esp. something considered worthy of attention);

(Oxford dictionary)
"<...> potential sources of nonconformities, either technical or concerning the
management system, shall be identified.
" = to show evidence of efforts to prevent nonconformities.



Really?! :mg:

I cant believe that standards can be so loosely interpreted...
 

Jim Wynne

Staff member
Admin
#15
"<...> potential sources of nonconformities, either technical or concerning the
management system, shall be identified.
" = to show evidence of efforts to prevent nonconformities.



Really?! :mg:

I cant believe that standards can be so loosely interpreted...
Well, the alternative is the absurd idea of (as you earlier suggested) trying to create a list of everything that could ever possibly go wrong.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#16
How to fulfill ISO17025 requirement 4.12:"<...>potential sources of nonconformities<...>shall be identified."
What does it mean?

Our Acreditation Body wrote up a nonconformity for us, which sounds something like this:
"Potential sources of nonconformities are not identified in the QualityManual/Procedures."

Does the standard really requires that while setting up a qms in an organization, all potential sources of possible nonconformities must be identified?

I understand that the standard requires preventive actions when the organization is already in the process: management meeting, analysis of data, customer feedback etc all can result in finding a potential nonconformity and the source of it.

But how to identify potential sources of NC before the whole process starts? Should we just guess a few sources at random, put it in the quality manual? :)
Hang on folks, there are several things going on here.

First, in your QMS - SOME - things can be identified up front, and subsequently addressed right away, such as incorrect measurements going to a customer, the obvious preventive action is calibration by an accredited calibration laboratory on an appropriate schedule. This type of appraoch may resolve your corrective action, but double-check with your AB first to make sure that is what they mean.

BTW, I am a fan of listing the preventive measures that are ALREADY in the Standard as preventive actions, with the disclaimers that they are not the only possible PAs.

Now, as to specifics. As you run across corrective actions or across preventive actions which will be unique to the situation, the subsequent corrective action and follow-on preventive action may well vary. For those, the system that is implemented becomes critical, and that MUST be described in your manual and/or lower level procedures.

Hope this helps.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#18
Then it appears you may be stuck and have to provide them a list, with the disclaimer that it is subject to change at any time as other potential sources are discovered and addressed. That is a resonable disclaimer to have.

Hope this helps.
 
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