ISO 13485 2016 Training Question

[QAG2024]

In order to remain compliant to ISO 13485 2016, when an SOP or WI is upreved, should employees read the document in it's entirety and sign off on each new revision? Or is an awareness email describing the changes made to the document sufficient?

Thank you.

 

[SeanN]

In order to remain compliant to ISO 13485 2016, when an SOP or WI is upreved, should employees read the document in it's entirety and sign off on each new revision? Or is an awareness email describing the changes made to the document sufficient?

Thank you.

I think this is an old topic. You can search and find a lot of discussions on this.
In short, documented training is just a way to show competence. Not a must.
Even if you fully document all kinds of trainings, with all signatures, trainers' and trainees', and evidences of incompetence can be found it's still an NC.

 

[Sidney Vianna]

In order to remain compliant to ISO 13485 2016, when an SOP or WI is upreved, should employees read the document in it's entirety and sign off on each new revision? Or is an awareness email describing the changes made to the document sufficient?

Thank you.

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