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.