ISO 13485:2016 - IQ/OQ Requirements applicable to Electronic Component Suppliers

[MonteS]

I work for a company that makes wafers for an ISO 13485-certified company, who in turn makes chips that go into medical devices. They are telling me that we MUST do IQs and OQs for our already installed equipment. True? Please detail your responses. Thanks!

 

[Ronen E]

Re: ISO 13485:2016 - IQ/OQ requirements applicable to component suppliers

Hello MonteS and welcome to the Cove

I have spun your post / question off the thread where you originally posted it to create a new thread, because it was an old thread from 2008 - the context of that thread was ISO 13485:2003 while now we have ISO 13485:2016.

To answer your question, I don't see an explicit requirement in ISO 13485:2016 giving rise to that request from your client. On the other hand, they can pose requirements that don't come directly from the standard. It might have something to do with the way they interpret / implement the standard inside their own operation. Did they highlight ISO 13485 as the source or trigger of their request?

 

[shimonv]

Hi MonteS,
I agree with Ronen. As a component manufacturer you are not subject to ISO 13485, but your client is and its easier for them to expect more of you weather justified or not. I doubt anyone will challenge them about your IQ/OQ processes unless there is a serious investigation going on.

Anyhow, the client is the client and you need to be smart in producing retrospective report (you can do IQ and OQ together) that shows that your process consistently produces good results.

Shimon

 

[MonteS]

Thank you shimonv and Ronen E for your replies, and thanks Ronen E for placing me into the correct forum. This is very helpful and appreciated. The mandate came from a very experienced consultant who is helping a startup attain ISO 13485 certification. Ronen E, he may be requiring this on his own, as you mentioned. I agree shimonv that I have to be smart about this. I am definitely leaning towards doing an "IOQ" for our key processes. My company is considering including 13485 with our recently-kicked off 9001 certification journey.

 

[Ronen E]

My company is considering including 13485 with our recently-kicked off 9001 certification journey.

Based on second-hand knowledge, I think that might be an inefficient path. Since the ISO 13485:2016 and ISO 9001:2015 updates the two standards seen to have diverged significantly and they don't mesh together as easily as they used to. Plus, I heard that people are saying that the added value of ISO 9001:2015 over an ISO 13485:2016 system doesn't justify the extra resources.

If you search Elsmar on this topic, you might find some interesting posts.