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Hi Guys, I am a new member and this is my first post. I work for a contract manufacturer. Our customers design products and supply us with the design. We design the process and manufacture the product. We are ISO 9001:2008 certified. We cater to the automotive, industrial and the medical device sector and we have now decided to pursue ISO 13485 certification. We hope to keep both standards (9001, 13485). 2 questions that immediately come to my mind are,
1. In order to keep both standards, would we have to classify each part as either medical or non-medical (in which case it would fall under 13485) OR would we have to create 2 organizations with 2 different standards?
2. Since we do not do any design work, which of the 13485 requirements not apply to us?
1. In order to keep both standards, would we have to classify each part as either medical or non-medical (in which case it would fall under 13485) OR would we have to create 2 organizations with 2 different standards?
2. Since we do not do any design work, which of the 13485 requirements not apply to us?