Training Records - How detailed? ISO 13485 Requirements

Bev D

Heretical Statistician
Leader
Super Moderator
Again, specifically, where is the requirement for "training records"?
Claudia_2023: It is best if you read 13485 and quote the specific section(s) that you think may require training records so we can help.
 

Bev D

Heretical Statistician
Leader
Super Moderator
Now my advice - if you care about the quality of the rework - would be to create a single sheet with the name of the rework instructions and then space for each operator to sign and date when they were trained to the instructions and a sign off for the supervisor or lead operator/trainer to indicate that they have observed the operator and that the operator properly executed the instructions. (I would also add some inspection that yoru organization performs if the severity of a defect is high). I would have the sub on keep a copy of the record and give you the original to file with the rework documentation. I have done this many times and have had no auditor not accept it.

If you only want to know what is required my previous post is the path forward for you.
 

claudia_2023

Registered
Now my advice - if you care about the quality of the rework - would be to create a single sheet with the name of the rework instructions and then space for each operator to sign and date when they were trained to the instructions and a sign off for the supervisor or lead operator/trainer to indicate that they have observed the operator and that the operator properly executed the instructions. (I would also add some inspection that yoru organization performs if the severity of a defect is high). I would have the sub on keep a copy of the record and give you the original to file with the rework documentation. I have done this many times and have had no auditor not accept it.

If you only want to know what is required my previous post is the path forward for you.
Many thanks Bev for your advise.
 
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