Does 13485 or the FDA QSRs require a medical device manufacturer to have documented procedures and/or training for administrative personnel involved with processing customer purchase orders and invoicing?

Does 13485 or the FDA QSRs require a medical device manufacturer to have documented procedures and/or training for administrative personnel involved with processing customer purchase orders and invoicing?

Doug,

As far as I know, the requirements are 1) that a procedure is established and 2) that the personnel who perform the job are trained and competent. I didn't see anything that explicitly says "thou shalt have xxx training for xxx personnel to do xxx job.." or such. As long as the personnel who perform the processing of customer purchase orders and invoicing have been trained in the company's procedures for these jobs (and assuming they also demonstrate competency), I don't see where there would be a problem.

If there is something I've missed, I'm sure someone will join in with additional comments. :)

Hope this helps.

The FDA training requirement comes from 21 CFR 820.25(b), "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities."

Doug,

in a recent FDA audit; the expectation was as follows:

1. Purchasing and invoicing person must have knowledge of and access to approved supplier list and approved products

2. Purchasing individual must be trained in the relevant sections of purchasing policies of 21CFR820

hope this helps !

All the three responses from Gidget, MIREMGR and Dash are apt and to the point - nothing more from me to add ;)