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Definition for critical suppliers in the context of ISO 13485

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Guest user Created:   Jan 17, 2019 Last commented:   Jan 17, 2019

Definition for critical suppliers in the context of ISO 13485

Hi, I am trying to find a definition for a critical part (to determine critical suppliers) in the context of iso 13485.
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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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Verlene Law Jan 17, 2019

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

Jan 17, 2019