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ISO 13485:2016—Getting Ready for Changes (Part 1)

MasterControl’s Walt Murray, a certified lead auditor in QMS standards, discusses ISO 13485 changes in 2016.

By: MasterControl

ISO 13485 is an international management standard developed specifically for medical device manufacturers. It provides a harmonized model for creating and maintaining an effective quality management system (QMS) for the design and manufacture of medical devices. In 2016, ISO 13485 was revised to address suppliers and incorporate risk. ISO 13485:2016 explicitly requires device makers to apply a risk-based approach to all quality processes, including outsourced processes, as well as more structure to validation, verification and design transfer. ISO 13485:2003-certified companies have three years to transition to ISO 13485:2016.

In this first of a three-part series, MasterControl’s Walt Murray, a certified lead auditor in QMS standards, discusses what, why, when, and how the ISO 13485 standard for medical device manufacturers will change in 2016. Once finished here, check out part 2!

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