ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. The standard details requirements for a quality management system that meets customer requirements and allows the incorporation of applicable regulatory requirements within an organization’s quality management system.
Work to revise ISO 13485 began in April 2012. Because the revision of ISO 13485 was the first since the standard’s last revision in 2003, the ISO working group responsible for the revision faced the significant task of addressing early a decade of changes in technology and regulatory requirements. In addition, during the years since the publication of ISO 13485:2003, existing management standards continued to evolve and new management systems standards were introduced. The ISO working group was also challenged with finding ways of integrating ISO 13485 requirements more closely with those of other management systems standards to ease the implementation and maintenance process for device manufacturers with multiple management systems in place. Activity related to the current revision of ISO 13485 was accelerated in 2015 with the publication of a second version of the Draft International Standard (DIS)/ISO 13485 in February 2015, and the release of a Final Draft International Standard (FDIS)/ISO 13485 on October 29, 2015 for balloting by ISO member countries. The revised standard ISO 3485:2016 was published on March 1, 2016.