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Are Medical device Raw material suppliers required to be ISO 13485 certified

mpfizer

Involved In Discussions
#1
Hi,

We are medical device manufacturers manufacturing equipment and orthopedic implants. In USFDA CE or ISO 13485 is there any clause or requirement that states that raw material suppliers have to be ISO 13485 certified especially for high risk devices . Suppose that the raw material supplier is certified to ISO 9001 and all lots supplied are tested to relevant ISO standards for chemical , physical and mechanical properties is it not ok?

Does ISO 13485 require suppliers to be ISO 13485 certified ?


Please comment

Thanks

michelle
 
Last edited:

mpfizer

Involved In Discussions
#3
Hi,

We are medical device manufacturers manufacturing equipment and orthopedic implants. In USFDA CE or ISO 13485 is there any clause or requirement that states that raw material suppliers have to be ISO 13485 certified especially for high risk devices . Suppose that the raw material supplier is certified to ISO 9001 and all lots supplied are tested to relevant ISO standards for chemical , physical and mechanical properties is it not ok?

Does ISO 13485 require suppliers to be ISO 13485 certified ?


Please comment

Thanks

michelle
would request more experts to comment please

Thanks

michelle
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
would request more experts to comment please
If ISO 13485 required suppliers to be certified to any management system standard, a requirement to that effect would exist in the document. As there is no such requirement, what additional comments you expect to the question?

Obviously, from a product conformity and business continuity perspectives, you want to ensure that critical suppliers have robust business and quality systems. Certification to a standard does not assure either one.
 
#5
ISO 13485, ISO 9001, 21 CFR 820 or any other QMS standard/regulation worldwide do not require sub-contractors to be ISO13485 certified.
You need to eshablish your own approach to selection, evalution and monitoring of our suppliers. ISO 13485 requires risk-based approach to each step based on the risk the purchased product as on the safety and performance of the medical device.

In your case, besides ISO 9001 and materiál testing, I would recommend also on-site supplier audit (critical supplier).
 

racglobal

Involved In Discussions
#6
Nothing in ISO 13485 requires the suppliers to be certified to the standard. The decision is up to you as to whether you require your suppliers to be certified. What is the risk of the supplied material with respect to safety? Is it a critical supplier? ISO requires that you control your suppliers; as to how you control your suppliers is a question for you and your top management.
 

indubioush

Involved In Discussions
#9
would request more experts to comment please

Thanks

michelle
I agree with what all others have said. There is no requirement that your suppliers have any certification.
Would I buy a low risk part from a supplier without a cert? Yes.
Would I select a contract manufacturer that had a 9001 cert but no 13485 cert? No.
 
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