Records required for ISO 9001 clause 7.1.5.1 - Fitness for purpose of the monitoring and measurement resources

Ajay Akole

Involved In Discussions
#1
In Clause No. 7.1.5.1 :
"The organization shall retain appropriate documented information as evidence of fitness for purpose of
the monitoring and measurement resources."

Which records shall me maintained to demonstrate this requirement as we are in to machining activity ? Please help.
Thanks in advance.
 
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Bran

Starting to get Involved
#4
Is not "Fitness for purpose" different than "Fitness for use"?

"Fitness for use" is easily demonstrated through calibration records for a device.

Wouldn't "Fitness for purpose" be a record that demonstrates a device is correct for the application? Calibration records would not cover this. MSA records seem to address this better, but may not go far enough. (For example, a tape measure may pass a GRR study, but that does not mean it is the correct device to measure very small linear distances better suited for a micrometer)
 

somashekar

Staff member
Super Moderator
#5
Without applying much English knowledge to the standard's words, what is not fit for purpose is not useful.....
 

Tagin

Trusted Information Resource
#6
'Fitness for purpose' is essentially referring to "are you using the right tool for the right job?" This has nothing to do with calibration status per se.

On our tool records, we have a field enter a text explanation of why that tool is suitable. In some case, it might be customer-directed or customer-supplied; in other cases, it could be to say that the tool can 1) perform xyz test within spec of customer reqmts, and 2) can be calibrated, and 3) can perform a self-test.

It doesn't have it be too complicated, unless the conditions that qualify that tool for that job are complicated.
 

dwperron

Trusted Information Resource
#8
Bran raised a great point on this.
Go up a couple of lines in 9001:2015 7.1.5.1:

"The organization shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their purpose."

This is nice and clear... until you get into the mud of the question in the original post.
"evidence of fitness for purpose ", though poorly written, applies to b) and would be the calibration / maintenance records.
 

AMIT BALLAL

Trusted Information Resource
#10
AMIT, could you please upload example of "Sample inspection report" in respect of topic discussed?
Any inspection report would be able to conform to this requirement of the standard. An inspection report will be able to to tell whether the measuring instrument is fulfilling the purpose i.e. Inspection (Measurement). You just need to check whether the instrument is correct one considering the purpose (Inspection/testing/ monitoring, etc.).
The requirement of calibration is addressed in clause 7.1.5.2.
 
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