Is the Design Service Provider required to be ISO 13485 certified?

SGquality

Quite Involved in Discussions
#1
My organization has outsourced the Design Controls for a Class II medical device to a service provider that is US FDA registered. The device is sold only in the US and technically the ISO 13485 does not apply.

When we are going thru our ISO 13485 certification, the question arose on why our service provider is not ISO 13485 certified. We explained that their system is 21 CFR 820 and is aligned to ISO 13485. Additionally when we audit, the elements of the ISO 13485 were verified. Also told him that the 13485 is meant to meet regulatory requirements.

He seems to be okay with this approach but might come back later and probably say that it is required for the supplier to be ISO 13485 certified as well.

Your thoughts on this please
 
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Randy

Super Moderator
#2
Did you see anywhere in 13485 where it's required?

Whether or not the answer is yes or no, then do accordingly.
 

SGquality

Quite Involved in Discussions
#5
Thanks Randy. Just curious, how would you respond?

Looks like he is giving an OFI after our explanation. I was resisting but my Manager slowed me down.
 
#6
So why do you have ISO 13485 certification if you don't actually need it? I would take the OFI and move on. If you are claiming compliance to ISO 13485 and then outsourcing some of those quality system processes to another company, it would be expected that they would be compliant to the relevant outsourced requirements. You should be able to show this just fine through the results of your supplier audit.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#7
The organization that produces the goods/services is subject to the industry standard. That organization's supplier(s) get subjected to the requirements that the organization defines. That may be 13485, or 9001, or something else.

In short, Standard schemes don't translate down to Tier 2, Tier 3 etc. suppliers.
 
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