Inspection of Initial Importer/ Distributor Products and Materials




I work for a dental medical device company who is currently going for ISO13485 and CE certifications. I have a question regarding the Receiving, Inspection and release of products from initial importers/distributors. Are there any suggestions in the receiving and inspection process? Currently we are using a form in which we fill out: 1) Date Inspected 2) Date Received 3) PO# 4) Invoice# 5) Reviewed and Released by, and lastly attaching all applicable documents. And that is all we are doing.

Are we required to check quantity, lot, serial etc, even though we are NOT the manufacturer? As per the regulations it states to document and that is all. If I would like to check the quantity what would be the simplest method without initiating a sampling plan for the products? Or is this a requirement?


go back to basics

why are you performing incoming inspection?

which risk management activity pointed out that the incoming inspection is a risk mitigation?

if it is linked to the risk mitigation, then it would be clear what you would require for incoming inspection, be it for identification, testing,..

Ee Bin
Top Bottom