Definition for critical suppliers in the context of ISO 13485
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Answer:
The Standard does not have a specific definition for critical suppliers. But you can refer to Clause 7.4.1 a to 7.4.1.e which presents the list of criteria for the evaluation and selection of suppliers. This can provide as a base to determine critical suppliers.
To see a document which specifies how to select suppliers, take a look at the free preview of this procedure:
-Procedure for Purchasing and Evaluation of Suppliers
https://advisera.com/13485academy/documentation/procedure-for-purchasing-and-evaluation-of-suppliers-iso-13485-2016/
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Jan 17, 2019