J
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2
What about we stay with the terms 'competence' and 'awareness'?
If training is required to achieve the necessary competence or awareness, OK, then training must be done.
But to insist on 'training records' when a manager / supervisor has provided a record that they are aware of the changed document... sheesh! I'm with Andy - an auditosaurus who should be brought into line (or shown the door). I'm glad you're challenging the finding - I would too.
You know I'm starting to realise the problem here. We need to define what we all mean by training. I mean everything from formal training to a quick self study by reading a document.
If training is required to achieve the necessary competence or awareness, OK, then training must be done.
But to insist on 'training records' when a manager / supervisor has provided a record that they are aware of the changed document... sheesh! I'm with Andy - an auditosaurus who should be brought into line (or shown the door). I'm glad you're challenging the finding - I would too.
is that a simple checkpoint in your change request form, where the requester and.or the approvers note whether the particular change warrants a training and/or notification.