Distributor vs Supplier quality agreement
Some of our products critical to the medical device are outsourced through the distribution chain. When discussing the Quality Agreement, do we ask for one from the distributor or the actual manufacturer?
We sent one of the agreements to the distributor, and he answered (and, frankly, had a point) that since he is not a manufacturer, this is not a binding document, applicable to his relationship with us.
How to deal with distributor vs manufacturer quality agreements? Who shall provide us with the quality agreement?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Quality agreement should be with the actual manufacturer because you need to be sure that the device is produced in accordance with ISO 13485 and MDR.
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Jan 25, 2023