Hello everyone
we are a plastic injection molding company and we are getting 9001 certified. Now there is an opportunity for some products but would require ISO13485 certification.
I am a little bit confused about all the requirements of clean rooms. I know it depends on the product itself but what are additional changes we have to implement in our facility? We are located in Florida and we are not air conditioned. The products would be class 2.
Do we need to create a clean room for those? also do we have to implement new ventilation systems? What kind of more documentations are required during the entire manufacturing process from purchasing to receiving, testing, molding, inspection and traceability?
Thank you in advance for your help
we are a plastic injection molding company and we are getting 9001 certified. Now there is an opportunity for some products but would require ISO13485 certification.
I am a little bit confused about all the requirements of clean rooms. I know it depends on the product itself but what are additional changes we have to implement in our facility? We are located in Florida and we are not air conditioned. The products would be class 2.
Do we need to create a clean room for those? also do we have to implement new ventilation systems? What kind of more documentations are required during the entire manufacturing process from purchasing to receiving, testing, molding, inspection and traceability?
Thank you in advance for your help