ISO 13485 is an internationally recognized standard that sets out necessities for a comprehensive management system for the design, expansion, manufacture, installation and servicing of medical devices. It is frequently seen as the first step towards achieving compliance with European, Canadian and other authoritarian requirements for medical device manufacturer. This system is essential for any organization working at any tier in the medical device provide sequence.
ISO 13485 key differences:
Although ISO 13485 is based on ISO 9001, a manufacturer that is acquiescent with this standard cannot also claim conformity with ISO 9001 due to the significant differences between those two standards. This system was written to meet the regulatory requirements of the medical devices industry and so it does not position the same amount of significance on purchaser satisfaction and continuous development found in ISO 9001.