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Supplier selection criteria - Medical devices

#1
Hello,

I am working in a start-up (no product on the market, first product still under development) and we are ISO 13485:2016 certified since early this year. During the certification audit, our auditor made an oral comment regarding our purchasing procedure : our criteria for supplier selection shall be reviewed and improved (we didn't get a deviation but a very insisting oral comment!)

Here is what is currently written in our procedure:

"The supplier is selected according to the following criteria:
The price,
The ability to meet deadlines,
The ability to meet specifications relative to the product / process or service,
The quality insurance, if appropriate (*),
The review of the quote and / or pieces of information communicated by the supplier,
The supplier’s notoriety or experience (**) and / or,
Samples testing, if judged appropriate.
If the company already worked with the company on other projects, the previous supplier/subcontractor evaluations are considered.
Supplier choice is materialized by the ordering.

(*)
The importance of quality insurance as a selective criterion is decided case by case, regarding the supply intended use, its impact on patient or user safety and the possibility to determine its compliance to expectations other than a documentary control. It makes sense that an ISO 13485 certification can be considered as essential for a subcontractor implementing cleaning, assembling and final sealing of the product. Proof of QMS certification should be made to the supplier."


I don't really know what to add here. Do you know specific guidance that could help me? I am also open to any suggestions/thoughts you may have!
Anything in compliance with FDA requirements will be a plus.

Thank you in advance
Mhalik
 
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François

Involved In Discussions
#2
Without more information regardong the comment from the auditor, it's difficult to determine what was the problem.
However, maybe your auditor would like you to have more defined requirements regarding the importance of quality as a criteria.


In our procedure we have identify 4 level of criticality for our suppliers :
- critical (critical or significative impact on Safety & Performances)
- non critical (could impair safety and performance)
- general (low impact on safety and performance)
- exempt : no direct impact on product

Based on this classification, we have different quality and control requirements.
 

yodon

Staff member
Super Moderator
#3
Agree with @François that it's difficult to comment given the information provided.

It's a bit bothersome to me that you list price as the lead-in criteria. I would hope quality would be #1. Remember: pretty much all decisions should be risk-based these days. If you're not tying your selecting / management to risk, you can expect some push-back by auditors.

How do you resolve the "if appropriate" aspects. @François gave a pretty typical grouping using risk-based criteria.
 
#4
Hello,

Thank you for your replies! Sadly, the auditor did not give any other information than "this is not sufficient, your purchasing manager has to improve the selection criteria", which is why I didn't really know how to help him.
I like the idea of the criticality levels and I agree we should avoid the price as lead-criteria. Yodon, your reminder about all decisions being risk-based these days is quite accurate and I guess this is the main issue of our current criteria.
I'll work on risk-based criteria with our purchasing manager, I'll come back if your opinions can come in handy again!
Have a great week!
 
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