I'm engineering student and now doing research on ISO 13485:2003 implementation and registration. I've read the standard but still blurr about the documentation requirements. Iíve found that ISO 13485:2003 documentation requires additional documented procedure compared to ISO 9001:2000 documentations, where minimum 19 procedures are required for the medical device manufacturers to be documented.
1. Is it a compulsory and manufacturer must comply all the 19 procedures?
2. Is the levels of documentation for ISO 13485:2003 is exactly same with those in ISO 9001 which have 4 levels of documentations? How about the criteria for each level? Is it similar?
3. Is it any additional contents for the quality manual, as well as another documents or records in order to meet regulatory requirements?
I hope anyone can gives me some directions about it. I did'n found much source and information about the ISO 13485:2003 documentation procedures and have tailoring it with those in ISO 9001:2000. Iím very appreciate for all the kind and attention. Thanx so much!