Do suppliers of prototyping components need to undergo supplier qualification?

[snoopy2017]

Hello everyone,

In the design and development of medical devices, do suppliers of prototyping components need to undergo supplier qualification?

Thanks.

 

[Sidney Vianna]

You are going to make business decisions based on the validation results, isn't it? Obviously prototypes have a critical function as part of the product design validation. So, from a risk mitigation perspective, why wouldn't you want to ensure that you are getting parts with the adequate level of quality, so you can trust the results of the prototype testing?

Without a doubt, the type, nature and extent of supplier qualification for this type of products can (and likely should) be very different from the qualification process used for volume production parts, but, in my opinion, irrespective of what 13485:2016 says, from a business perspective, yes, I would qualify such suppliers.

 

[PeterLe]

In our company, if R&D wants to add a supplier into our Quality System we add them as a class 4 supplier (lowest rigor in the supplier qualification process), . If then R&D wants to move forward with that supplier in order to do design validation and verification, then we add them as a Class 1 supplier (highest class, more rigor on the qualification process).

 

[Edward Reesor]

All critical suppliers should undergo a qualification process as a matter of due course, especially in the design and prototyping stage (IMHO).

We don't qualify suppliers of everyday commodities as it opens up a whole can of worms (do you also consider your bank and notifying body/auditing organization as critical suppliers as well?)