ISO 13485 Certification for Resin Manufacturer

chris1price

Trusted Information Resource
There is no obvious reason why they shouldn't be certified. I know of both polymer and silicone manufacturers who are certified to ISO13485. The bigger question is what is the benefit and do their customers want them to be certified?
 

angel1204

Registered
There is no obvious reason why they shouldn't be certified. I know of both polymer and silicone manufacturers who are certified to ISO13485. The bigger question is what is the benefit and do their customers want them to be certified?

It is not a customer request, it is more to marketing strategy.
They believe, with the ISO 13485 certification, it would be more easier to attract/convince medical device manufacturer to buy their resin.
I am asking this question, because some certification body is query about the medical devices in their certification scope.
 

NikkiQSM

Quite Involved in Discussions
It is not a customer request, it is more to marketing strategy.
They believe, with the ISO 13485 certification, it would be more easier to attract/convince medical device manufacturer to buy their resin.
I am asking this question, because some certification body is query about the medical devices in their certification scope.

I work at a medical resin compounding facility and we are ISO 13485:2016 certified. We did it for both marketing, and to meet our customer's request. We have many very well known customers who would continuously audit us against 13485, regardless of us being 9001, therefore, almost forcing us to update our system to ISO 13485. Its worked well for us. We exclude the clauses that are not applicable, such as sterilization.
 

angel1204

Registered
I work at a medical resin compounding facility and we are ISO 13485:2016 certified. We did it for both marketing, and to meet our customer's request. We have many very well known customers who would continuously audit us against 13485, regardless of us being 9001, therefore, almost forcing us to update our system to ISO 13485. Its worked well for us. We exclude the clauses that are not applicable, such as sterilization.

Thanks for the information, really appreciate it...have a nice day
 
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