Does ISO 13485 require Gauge R&R's?

A little off subject but 13485 related. Does 13485 require gauge R&R's?

Bob, I've moved your post to its own thread since it's off topic in the other one.

The short answer to your question is no. Gage R&R's are not mentioned at all in ISO 13485. Statistical techniques are mentioned in 8.1, as they are in ISO 9001.

trainerbob said:

A little off subject but 13485 related. Does 13485 require gauge R&R's?

Click to expand...

I agree with Steve. ISO 13485 is a Quality Management System standard - it tells you what to do but you have to define the "how".

Gage R & R is used to support the measurements of statistical testing and to prove the R & R of the measurement system.

Gauge R&R can be one of the quality tools you use in support of production/process controls, verification/validation activities, as well as your calibration program.

But as mentioned above, it is not explicitly mentioned in ISO13485:2003 standard.