Training Validation
I'm attempting to devise a way to validate training, and am wondering if I need to do something for each SOP, or if I can simply create different versions of quizzes for a group of SOPs, and test on a quarterly or monthly basis. Any ideas would certainly help. Thank you!
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Requirement 6.2 Human resources from ISO 13485:2016 states that the organization must document how to evaluate the effectiveness of the training. So there is what needs to be done, and not how to do it. It is totally up to you to define the method of training validation. Only keep in mind that you need to ensure the competencies for a particular job and the awareness in employees how they participate in the quality of both products and systems.
Your idea to create a different version of quizzes for a group of SOP sound great.
Here you can see how we in our ISO 13485:2016 documentation toolkit have prepared human resource procedure and record:
- Procedure for Human Resources https://advisera.com/13485academy/documentation/procedure-for-human-resources-iso-13485-2016/
- Training Record https://advisera.com/13485academy/documentation/training-record-iso-13485-2016/
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Nov 06, 2020