I was recently given a noncompliance against ISO 13485: 2016, clause 6.2 Human resources because of the NOTE " The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided."
I am a contract converter with simple processes, all training has been documented but not identified as one process riskier to the end product than another process.
First of all, can I get a noncompliance for a NOTE???? I'm confused.
I am a contract converter with simple processes, all training has been documented but not identified as one process riskier to the end product than another process.
First of all, can I get a noncompliance for a NOTE???? I'm confused.