ISO 13485

ISO13485 is the quality management system requirement applicable to supplier of medical device.


The latest ISO13485:2003 has replaced ISO13485:1996 and ISO13488:1996 by the year 2006. This standard is one of the regulatory requirement compliance with the EU CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical device Regulations and other international requirements.


Based on the process model of ISO9001:2000, ISO13485 put emphasis on the identification, documentation and control of the risk of the medical device under intended or unintended use. In addition, ISO13485 added the requirement of cleanliness and contamination control, identification and traceability control and specific requirement for medical device.