ISO 13485
The full name of the ISO13485:2003 standard is "Medical Devices - Quality Management System - Requirements for Regulatory Purposes" (Medical device - Quality management system - Requirements for regulatory purposes). This standard was developed by the SCA/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee and is an independent standard based on ISO9001:2000. The standard sets out the requirements for the quality management system of relevant organizations, but it is not an implementation guideline for ISO9001 standard in the medical device industry.
