Is Annual QMS Training Required? ISO 13485

#1
I recently became the manager of QA/RA/SC for a medical device start-up and noticed that the old QA manager had implemented an annual QMS training "refresher" for everyone in the company, but I was wondering if this is even necessary as long as everyone is up to date on the most current revisions of required procedures (and training is documented, of course)?
I'm considering either obsoleting the annual QMS training or updating the procedure to state that it is only required every 3 years. Please advise! Thanks!
 
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qualprod

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#2
I recently became the manager of QA/RA/SC for a medical device start-up and noticed that the old QA manager had implemented an annual QMS training "refresher" for everyone in the company, but I was wondering if this is even necessary as long as everyone is up to date on the most current revisions of required procedures (and training is documented, of course)?
I'm considering either obsoleting the annual QMS training or updating the procedure to state that it is only required every 3 years. Please advise! Thanks!
Need of training for people is recommended for several reasons:
There are a practice called Training detection, this is performed yearly.
The idea is to detect the training need for people, people don´t learn forever.
There are multiples causes why constant training is needed.
-staff turnover
-People moved to other area and forget old procedures
-Human start to forget.
Specific training, suddenly the company is producing new products and need special training, maybe speak
spanish, french, training to manage brass welding, stainless steel welding, etc.
So, schedule training every time is needed, not every 3 years.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
What exactly does "annual QMS training "refresher"" entail? Does it add value or is it just an a$$-covering?
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Can you cite anything in ISO 13485?
It can be a pretty handy, multi-purpose a$$ cover. ISO 13485 has multiple references to that vague "maintenance of QMS effectiveness", as well as some training-related verbiage that could be argued to be (at least partially) satisfied in such a manner.
 
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