Re: Confused
I have been researching ISO 13485 and planning to implement a quality managment system for the company I am working for and I'm a bit confused, or I am just think way to far into this. We are a manufacturer of medical equipment and also medical devices. My question is would all of the clauses under ISO 13485 apply to the equipment as well or just the medical devices produced? I thought the idea of a QMS was to have one unified system not just following procedures for one asspect of the company... Please help!! I'm stressing thankfully we have a long weekend
Do you ONLY make medical device products? If so there is no reason to not include all processes as required by the standard. You don't register a device to the standard... that's what the FDA is for. You register your processes to the standard and who cares how many devices you make.
That being said, I've worked at a company where there were multiple business units at one site and only one was ISO 13485 registered... but we had to make sure that everything was clearly segregated.
For example: if there is a machine used for all businesses - it had to be controlled per the QMS. If there was a machine that wasn't used for the device business then we excluded it from the QMS and we were NEVER to use if for QMS business.
Since the same ERP system was used for all business units, it had to meet QMS requirements
But there were different contract review processes, so only the device process had to meet QMS requirements.
It was not easy and there was lots of room for sloppiness.