ISO 13485: 2016 Part 2: Getting Ready for Changes

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.

Previous Video
ISO 13485: 2016 Part 1: Getting Ready for Changes
ISO 13485: 2016 Part 1: Getting Ready for Changes

What, why, when and how the ISO 13485 standard for medical device manufacturers will change in 2016.

Next Video
ISO 13485:2016 Part 3: Getting Ready for Changes
ISO 13485:2016 Part 3: Getting Ready for Changes

The Ultimate Guide to Connected Data!

Read More