ISO 9001 versus ISO 13485 for Suppliers to Medical Device Companies

racglobal

Involved In Discussions
#1
Hi everyone,

Many suppliers (e.g. PCB manufacturers) are ISO 9001 qualified. However, this does not exactly meet the requirements of a medical device company that requires their high risk suppliers to be QMS certified to ISO 13485. Without ISO 13485 certification, how can we ensure these ISO 9001 suppliers to meet a medical company's quality requirements? Exercise 100% inspection and frequent audits?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
how can we ensure these ... suppliers ... meet a medical company's quality requirements?
Start by having these requirements defined and documented super-clearly, and then address them specifically. 100% inspection and frequent audits are possible tools but not necessarily needed. Canned solutions lead to canned results.
 

somashekar

Staff member
Super Moderator
#3
ISO 13485 is simply not a tool to address your high risk. I would argue as to why a PCB manufacturer (example) requires an ISO 13485.
ISO 9001 in itself is a complete powerful standard which, when implemented and maintained in its true spirits, meets your high risk mitigation.
Look out for the CB and the accreditation through whom your high risk suppliers have the ISO 9001. If you are not so sure, make your own focused 2nd party audit on these suppliers to evaluate from your risk perspective.
 
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