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Supplier Control - Supplier quality management certificates (ISO, etc)

S

snoopy2017

#1
Hi everyone,

When are we required to request a supplier's quality management certificate (ISO, etc)? Is this dependent on the risk of the supplied product? For example, should we request QMS certificates only from critical suppliers?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
When are we required to request a supplier's quality management certificate (ISO, etc)?
Whenever your own (internal) supplier evaluation, selection and qualification SOP says so.

Is this dependent on the risk of the supplied product?
It can be (and it makes some sense).

For example, should we request QMS certificates only from critical suppliers?
It is up to you how to control your suppliers. If you do decide to go this way, make sure to include a clear, unambiguous and practical definition of “critical suppliers”.
 

Ajit Basrur

Staff member
Admin
#3
Agree with Ronen.

To keep a track of supplier's ISO certificate or not, is part of the risk based approach in your Purchasing Controls and is based on the risk the purchased product has on the safety and performance of the medical device or the suitability, adequacy or effectiveness of your QMS.

Typically, the purchasing process involves selection, qualification, and monitoring, and your scenario applies to the "monitoring" phase. As per the new ISO 13485 Practical Guide, you could use incoming inspection, auditing, and feedback processes too to support the monitoring phase.
 
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