Maintaining Dual Standards ISO 9001 and ISO 13485 - Contract Manufacturer

[rclanzillotto]

Although perhaps not required, I would strongly recommend ISO 13485 for your medical device, in particular for patient equipment. Most any customer would expect it and I would be wary of those who don't. You take on some risk when you send medical devices into distribution...even as a contract manufacturer. You need to be proactive with respect to risk analysis; etc. IMHO. I could understand ISO 9000 for certain types of components but not Medical Devices

[MIREGMGR]

I'd think you'd want your contract review team to be unwilling to sign off on an incoming P.O. unless Sales has gotten the customer to objectively clarify what it is that they are expecting.

Presumably those of your customers who want you to make a non-medical device will have an expectation that your QS will include those elements of 9001 that are not part of 13485. Those making medical devices will expect those parts of 13485 that are not part of 9001.