Configuration Management - ISO 9001 - 7.6 Monitoring and Measuring Equipment

[Jim Green]

7.6 Monitoring and Measuring Equipment

What does configuration management mean exactly???

A few examples would be helpful.

Thank you

Can I throw in what I think it means?

We have measurement devices ooppss, I mean measurement equipment IE micrometers and calipers. We do Gage R&R on this equipment. We plug the data into a software package to get the results. Now I have to determine if the software is on the up and up. Do I figure the calcultations with a pencil and paper using known formulas to see if my calculations match???

Am I way off base???

[AndyN]

JIm:

Where are you seeing configuration management in this section of ISO 9001?

[Jim Green]

Hey Andy,

At the very end in the note section:
"Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use."

Not sure what to do here?

Thanks

[Al Hector]

In Reply to Parent Post by Jim Green

7.6 Monitoring and Measuring Equipment

What does configuration management mean exactly???

I’m not familiar with this subject but after a quick search I think that this new note can be related with the standard ISO/IEC 90003:2004, Software engineering - Guidelines for the application of ISO 9001:2000 to computer software.

Alin

[AndyN]

Aha - the note! OK, it simply means that as the software is updated (whether it's in house generated or by a vendor update/patch etc.) you simply have to keep track and verify the update didn't affect the calcs performed.

Before this (2008) note, it might have been handled in two ways, the 'document control' of the software (version #) and the (periodic) validation that was required.

Does that help?

[Jim Green]

Yes Andy

Thank you