Quality Agreement template
I purchased the documents toolkit for 13485 and 14971, but I notice there is no Quality Agreement template in it for our vendors. Do you have one of those?
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No, unfortunatelly we do not have Quality Agreement template in our Toolkit. The purpose of Quality agreement is to define all obligations and responisibilities between manufacturer of medical devices and supplier. However, obligations and responsibilities differ from supplier to supplier (it is not the same whether it is a supplier of critical raw material, some service or some consumables), and therefore it is difficult to unify it. If you tell me which supplier it is, I can help you with the specifics of the contract. As part of the toolkit, you can schedule a call with our ISO 13485 expert, and there you can discuss what you should include in such an agreement.
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Dec 30, 2019