I'm wondering how in depth I need to be in regards to training validation. Our training consists of reading the SOPs, and then signing off on their personal training records. My predecessor suggested creating an assessment quiz for each SOP, but it seems a little more labor intensive than the standard requires. I am thinking it might be more beneficial to create QMS assessment quizzes for certain processes (manufacturing dept, shipping dept, etc.) and then testing on a quarterly basis for comprehension and retention. ISO 13485 doesn't specifically say how this should be handled. I would appreciate any suggestions or feedback. Thank you!
Assign topic to the user
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
Yes, you are right that ISO 13485:2016 does not specify how to handle the training validation. The only requirement in 6.2 Human resources is to evaluate the effectiveness of actions taken for the training. So, it is up to you how you will do it. I would like to point it here that it is also stated in the note of requirement 6.2 that the methodology used to check effectiveness is proportionate to the risk associated with the work for which the training is provided. It means that you decide which training there is a necessity to perform validation and to which there is no need for it (based on the risk).
Sometimes, the method can be a quiz, sometimes it can be checking the person in everyday work, sometimes during an internal audit, you can check is whether everything is done in the prescribed and appropriate manner.
The following article can provide you more information about effectiveness:
- How to measure training effectiveness according to ISO 9001 - https://advisera.com/9001academy/blog/2016/03/29/how-to-measure-training-effectiveness-according-to-iso-9001/
Comment as guest or Sign in
Nov 10, 2020