Monitoring and measurement - 7.6 of ISO 13485 - Documented procedure required?

C

Charles Wathen

Involved - Posts
We were asked by a KEMA auditor the following question regarding ISO13485:

"The organization shall establish documetned procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements"

This was taken from secion 7.6 - Control of Monitoring and Measuring Devices.

And this comment from the auditor:
What section 7.6 of the ISO 13485 standard calls for is a "procedure" that "ensures" that the right equipment is being used. I am confident that your "professional staff members ... know which tools are required" as you state in your email below, but what "procedure" gives them the guidance and or policy on the basis of which they make their decisions? That is, how do they make the decision that, for a given measurement tolerance, the given measurement equipment has adequate accurracy (as opposed to resolution, which has no reliable relationship to accuracy)?
Click to expand...

In my calibratin lab, we document the process and determine the standards necessary to perform the calibration by meeting a 4:1 calibration ratio. Our internal auditor mentioned to the KEMA auditor that QE's are responsible for determing what tools have the accuracy and precision to perform inspections for commodities, inprocess, or final inspections that are documented in formal inspections plans, but we do not have a procedure that has this information.

Anyone care to comment on this?
 
F

fuzzy

Re: Monitoring and measurement

Charles Wathen said:
We were asked by a KEMA auditor the following question regarding ISO13485:

"The organization shall establish documetned procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements"

This was taken from secion 7.6 - Control of Monitoring and Measuring Devices.

And this comment from the auditor:


In my calibratin lab, we document the process and determine the standards necessary to perform the calibration by meeting a 4:1 calibration ratio. Our internal auditor mentioned to the KEMA auditor that QE's are responsible for determing what tools have the accuracy and precision to perform inspections for commodities, inprocess, or final inspections that are documented in formal inspections plans, but we do not have a procedure that has this information.

Anyone care to comment on this?
Click to expand...

While not an expert on ISO 13485:notme: , it sounds like your auditor has a valid finding here...do you have a documented procedure and does it state how you will ensure M&M requirements are met; they can be your requirements (QE's use a 4:1 ratio) or industry accepted standards (10x the tolerance, NIST, ANLAP, etc) but you should reasonably define the critical standards used to ensure capable results.:2cents:
 
Jim Wynne

Jim Wynne

Leader
Admin
Re: Monitoring and measurement

Charles Wathen said:
We were asked by a KEMA auditor the following question regarding ISO13485:

"The organization shall establish documetned procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements"

This was taken from secion 7.6 - Control of Monitoring and Measuring Devices.

And this comment from the auditor:


In my calibratin lab, we document the process and determine the standards necessary to perform the calibration by meeting a 4:1 calibration ratio. Our internal auditor mentioned to the KEMA auditor that QE's are responsible for determing what tools have the accuracy and precision to perform inspections for commodities, inprocess, or final inspections that are documented in formal inspections plans, but we do not have a procedure that has this information.

Anyone care to comment on this?
Click to expand...

It's possible that what the auditor is trying to get at is that you don't have a documented process for verifying that a given measuring device is appropriate for specific applications. It doesn't matter if a device is properly calibrated and has a resolution that's considered appropriate for the UOM and tolerance if it's not the right tool for the job, and measurement results can't be repeated and reproduced within acceptable limits.
 
Marc

Marc

Fully vaccinated are you?
Leader
I con't have a copy of the standard here. Does it specify a documented procedure, or does it just say you need a procedure?
 
R

Rob Udo

Charles,

I agree with Jim

"It's possible that what the auditor is trying to get at is that you don't have a documented process for verifying that a given measuring device is appropriate for specific applications. It doesn't matter if a device is properly calibrated and has a resolution that's considered appropriate for the UOM and tolerance if it's not the right tool for the job, and measurement results can't be repeated and reproduced within acceptable limits."

This can either be achieved by:
- stating measurement accuracy requirements in your inspection reports
- stating measurement ID on inspection reports
- train inspectors on company policy regarding accuray of measuring equipment and have it documented.

Good luck

Rob udo
 
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