In Reply to Parent Post by DrM2u
Stonehouse, you are correct. There is no requirement in ISO9001 or ISO 13485 to keep records of impact of equipment failure on product quality. Is it good practice to do so?!? Depends ... There are a few considerations:
An auditor will/should not document any findings against an inexistent requirement, regardless where in the world they are. Hope these thoughts help some.
I'm digging out from a brutal ISO 13485 / 9001 surveillance audit and had the following finding against me which sounds similar to what is being discussed here:
"Preventive Maintenance Procedure, XXXXX Rev X, does not clearly address corrective/demand maintenance and the possible impact on product quality as the result of performing such maintenance."
I re-read Clause 6.3 and I'm at a lost as how to derive the statement above out that clause. As stated here it is a good idea and a good practice to do such but how can I be written up for not meeting a requirement when it isn't an actual written requirement?