Q
Quality96 - 2011
I am the QA Manager for a large medical device manufacture based in Germany with 30+ subsidiaries around the world; 18 of which are ISO 13485 certified, 12 do not have a certified QMS in place. My current project is to install an ISO 13485 QMS in these 12 locations.
My question is: Can we have a single ISO certificate for two different business entities (Subsidiaries) that happen to be located in the same building. Entity one fabricates custom devices; entity two services & repairs a completely different product line manufactured in Germany, and sold in the USA. These two entities have nothing to do with each other, except that they are in the same building.
Any advice will be greatly appreciated,
Bill
My question is: Can we have a single ISO certificate for two different business entities (Subsidiaries) that happen to be located in the same building. Entity one fabricates custom devices; entity two services & repairs a completely different product line manufactured in Germany, and sold in the USA. These two entities have nothing to do with each other, except that they are in the same building.
Any advice will be greatly appreciated,
Bill