Guest user Created: Jan 22, 2021 Last commented: Jan 22, 2021

Which clause should I refer for supplier qualification?

Can I know which clause should I refer for supplier qualification?
for ISO 13485: 2016 - Is it 7.4.2 (c)?

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Kristina Zvonar Brkić Jan 22, 2021

Supplier qualification is mostly covered in the requirement 7.4.1 Purchasing process where is required that criteria for evaluation and selection of supplier must be defined and determined.

For more information on purchasing process please see the following articles:

How can ISO 13485 clause 7.4, Purchasing, enhance procurement? - https://advisera.com/13485academy/blog/2018/04/18/how-can-iso-13485-clause-7-4-purchasing-enhance-procurement/
How to evaluate supplier performance according to ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/10/27/how-to-evaluate-supplier-performance-according-to-iso-90012015/
Purchasing in QMS – The Process & the Information Needed to Make it Work https://advisera.com/9001academy/blog/2014/03/18/purchasing-qms-process-information-needed-make-work/

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Jan 22, 2021

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