Hi all,
My company implemented all required changes for ISO 13485:2016, including verification of training effectiveness based on risk. Our procedure includes quizzes or demonstration of knowledge for high risk, discussions for medium risk and monitoring for low risk.
This has been working for us, but we have come upon an issue when documents are changed. When documents are changed, we always retrain employees that were trained on that document. We do not have a method of verifying the effectiveness of this retraining. It does not make sense to have employees retake a quiz each time a high risk procedure is minorly changed. Does anyone have any ideas for this situation? Thank you!
My company implemented all required changes for ISO 13485:2016, including verification of training effectiveness based on risk. Our procedure includes quizzes or demonstration of knowledge for high risk, discussions for medium risk and monitoring for low risk.
This has been working for us, but we have come upon an issue when documents are changed. When documents are changed, we always retrain employees that were trained on that document. We do not have a method of verifying the effectiveness of this retraining. It does not make sense to have employees retake a quiz each time a high risk procedure is minorly changed. Does anyone have any ideas for this situation? Thank you!