ISO 13485:2016 Published

The third edition of this standard for a medical device Quality Management System (QMS) is published with a date of March 1, 2016. It has eight major clauses, similar to ISO 13485:2003.

Normative References
Terms and Definitions
Quality Management System
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis, and Improvement

The third edition cancels and replaces the second edition (ISO 13485:2003) as well as ISO/TR 14969:2004.

This new edition is a stand-alone standard based on ISO 9001:2008, not the current version ISO 9001:2015.