Use of Employee Assessments for ISO 13485:2016



We will be using a process for competence and training effectiveness in six ways. Looking to see if anyone has advice or experience.

1. Training survey right after training is completed. Two surveys...first being the trainee rating the training. Second is the trainer rating the trainee's performance.

2. High level assessment two weeks after training...can the employee perform their job with higher yields, less scrap, etc. This will also look to see if the employee is competent.

3. More in depth assessment three months post training. Managers in one plant felt it was important that the assessment is open book. Their reasoning is that we ALWAYS want people to refer to their SOP's and not memorize anything. My question on this, is....will an auditor find fault with open book? We will also have questions not pertaining to SOP's, i.e. how to read a ruler, using decimals, etc.

4. Six month group-training on different procedures. We plan on making the group training a Jeopardy game with clicker-presses. Each question asked will be discussed on the right/wrong answers.

5. Internal audits with observations rating the employee on doing their job effectively, efficiently, and safely.

6. Annual re-certification to the processes they work on.



Super Moderator
Don't overlook the note at the bottom of the section:

NOTE The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided.

So it's not necessarily the case that effectiveness be assessed the same way for everything.

I expect what you outline will be acceptable; who knows what an auditor will find fault with. :) If you're not having NCs due to ineffective training then you're probably doing something right.
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