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Have a question for those of you here that have a little more experience than I do...
The company that I work for is currently registered to ISO 9001. Approximately a third of our customers are medical, but we don't build anything that is a direct medical device. They end up being components that are used in an all-up product by an OEM (our products are input devices, typically keyboards). We are thinking about becoming certified to ISO 13485. My questions are:
If our customers aren't requiring it is it a good idea? Does anyone out there have customers that require registration to ISO 13485?
We also build a lot of non-medical products and do not want to impose the 13485 requirements in those instances. Is it acceptable to say that the scope of our 13485 QMS is medical customers only?
Thanks!
The company that I work for is currently registered to ISO 9001. Approximately a third of our customers are medical, but we don't build anything that is a direct medical device. They end up being components that are used in an all-up product by an OEM (our products are input devices, typically keyboards). We are thinking about becoming certified to ISO 13485. My questions are:
If our customers aren't requiring it is it a good idea? Does anyone out there have customers that require registration to ISO 13485?
We also build a lot of non-medical products and do not want to impose the 13485 requirements in those instances. Is it acceptable to say that the scope of our 13485 QMS is medical customers only?
Thanks!
...we make tubing (non-sterile) used in many different industries, mostly medical tubing which is incorporated into a medical device by OEM (customers). Component manufacturers currently do not register with FDA, yet OEMs are required to control their suppliers (us) and are looking for compliance to FDA QSR (cGMP for medical devices) or ISO 13485 (for our international customers) we elected to have ISO 13485 certification for one of our seven facilities that specifically makes implantable component materials. This was a business decision (not required by customers) and we have seen benefits from a marketing/sales perspective.