ISO 13485 certification training

S

Sruthi Nayudu

Registered
#1
#1
I was wondering if we need ISO 13485 training to be delivered by a certified auditor/ trainer for it to be recognized as a certified course or is it acceptable if anyone with good knowledge about ISO 13485 to deliver the training and provide the certification.
 
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Y

yodon

Leader
Super Moderator
#2
#2
Certification is not required. (And I've seen certified trainers with no practical experience and so while they could spout the text, they didn't understand application!) As with everything, a role (trainer) just has to have competence to perform that role. You need to be prepared to defend why you believe the trainer had the necessary competency: this could be through certification or a resume.

Side note: while there are likely some that do need 13485 training, the bulk of training, I believe, would need to be to your application of 13485; i.e., your SOPs.
 
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