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?
"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)?
Anyone care to comment on this?
, 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.