In part two of a three-part series about ISO 13485:2016, Walt Murray outlines the principal differences in the new quality management system (QMS) standard for medical device companies. As of March 2016, ISO 13485:2016 replaces the 2003 version of the conformance standard.
Among the major changes in the more globally focused standard are a greater emphasis on harmonization and the entire life cycle of a device. The revision also requires a more risk-based approach, particularly if your QMS is not fully integrated; and it increases the structure surrounding software validation, verification and design transfer.
ISO 13485:2016 also includes updated requirements and responsibilities for outsourcing processes for external parties and design controls as a critical product characteristic. Finally, Walt reviews what companies need to do in order to plan and implement a transition to ISO 13485 version 2016 to certify under the revised edition.