Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2
On the context of the Medical device sector, the ISO/TIR 14969 can be used as the guideline for the application of ISO 13485. This guideline document refers to "...follow-up or refresher training, as needed and planned"
On the context of the FDA's 21 CFR 820.40 we could also refer to the following requirement:
"Approved changes shall be communicated to the appropriate personnel in a timely manner"
So, I would not say this is necessarily a repeat training, rather it is keeping the people effectively aware of the relevant changes to their processes. The QSR also refers to: "ensure that all personnel are trained to adequately perform their assigned responsibilities". If the responsibilities change, then training is appropriate. This is why in my opinion this system needs to be robust. In the medical device sector the worst enemy could be one self, I mean, one self in case of un-compliance could have a person's life at risk, so I think it is worth the effort to apply training on prevention of mistakes.