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Quality Agreement template

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Guest user Created:   Dec 26, 2019 Last commented:   Dec 30, 2019

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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Dec 30, 2019

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 26, 2019

Dec 30, 2019