En iso 13485 purchase11/1/2023 ![]() It needs to take into consideration the performance of the supplier.The criteria need to evaluate the supplier’s ability to provide a product that meets the requirements.The organization must have established criteria for the evaluation and selection of suppliers.In light of that, ISO 13485:2016 sections 7.4.1 Purchasing process, 7.4.2 Purchasing information, and section 7.4.3 Verification of purchased product outline the purchasing requirements. The following are requirements for the evaluation and selection of suppliers: As part of a compliant quality management system, purchasing controls must be in place to ensure that quality products and materials are going into your device and that any service providers that your company uses in the production of your product or within your quality management system are qualified. Sourcing suppliers in the medical device industry is not as simple as going on the internet and finding your material and purchasing it.
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