ISO 13485:2003 Medical devices - Quality management systems

ISO 13485 is published in 2003 that represents the requirements of a comprehensive management system for the design and manufacture of medical devices. Standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

The primary objective of ISO 13485 was to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability.