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As part of our ISO 13485 Documentation toolkit, we have prepared two types of quality agreements: one for critical suppliers and a quality agreement for subcontractors. The subcontractor is a company who produces something especially for you like in your example. Critical suppliers are all those suppliers which can have a significant impact on the quality and/or safety of your product.
Preview of those two contracts you can see on the following links:
- Quality Agreement for Subcontractor https://advisera.com/13485academy/documentation/quality-agreement-for-subcontractor/
- Quality Agreement for Critical Supplier https://advisera.com/13485academy/documentation/quality-agreement-for-critical-supplier/
Of course, these contracts cover all mandatory parts, but it is possible that you add important points to you.
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Mar 04, 2022