Does ISO 13485 have any Trainer Requirements

T

TJG954 - 2009

#1
While 21CFR820 has guidelines for who can be a trainer, does ISO have any requirements for trainers?
 
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Stijloor

Staff member
Super Moderator
#2
Re: iso trainer requirements

While 21CFR820 has guidelines for who can be a trainer, does ISO have any requirements for trainers?
If you are referring to ISO 9001:2000, no, they just need to be competent.

Stijloor.
 
Last edited:
F

freelovefest

#4
Re: Does ISO 9001 have any Trainer Requirements

820 originally had a requirement for "Qualified Inidividuals" to perform training, but they removed it in that they deemed this was already evident in 820.25(a). You can find this in the QSR preamble. I have pasted the appropriate section below. I hope this helps

60. In Sec. 820.25(b), ``Training,'' FDA deleted the requirement
that employees be trained ``by qualified individuals,'' because
Sec. 820.25(a) requires this. Several comments stated that FDA should
add the requirement that the training procedure include the
identification of training needs, to be consistent with the
requirements in ISO 9001:1994 and ISO/CD 13485. Other comments stated
that personnel need not be trained to the extent that they can quote
chapter and verse of the regulation as long as they can adequately
perform their assigned responsibilities. Several comments suggested
deleting the requirements in the last two sentences in favor of a
broad, general requirement that personnel be trained. A few comments
stated that the last two sentences should be retained because they are
crucial and sound requirements but that validation activities should be
included with verification activities.
 
#5
Re: Does ISO 9001 have any Trainer Requirements

There are no requirements in ISO 9001 for anyone performing training - unless you make a training product.

The requirements for competency apply to personnel who perform work affecting product quality, not the trainers who train them..........

It makes sense to have competent trainers, naturally, but you can't make ISO 9001 a requirement, in this case........
 

GStough

Staff member
Super Moderator
#6
While 21CFR820 has guidelines for who can be a trainer, does ISO have any requirements for trainers?
There may not be much if any difference in the trainer requirements, but I believe Ted is asking about the 13485 standard, not 9001, since he posted this in the ISO 13485 - Medical Devices forum.

With that in mind, I have changed the thread title to reflect 13485. If I'm wrong, please let me know. :)
 

Doug Tropf

Quite Involved in Discussions
#7
ISO 14969:2004 (Guidance on the Application of 13485:2003) under 6.2.2, (Competence, awareness and training) states, "Training should be carried out by personnel with appropriate skills, qualifications and experience. Records are typically kept to document the qualifications of the personnel used as trainers."
 

GStough

Staff member
Super Moderator
#9
Thanks for catching that Gidget - I must work on the fact that 'ISO' doesn't always mean 9001 to everyone..........:eek:
No problem, Andy. After 16 years in medical devices, the same thing still happens to me sometimes, only in reverse. ;)
 
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