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Dec 17, 2015

Preparing for ISO 13485:2016 Changes

by James Jardine, Marketing Communications, MasterControl


As 2015 comes to a close, medical device manufacturers throughout the world share one collective concern: how will the ISO 13485:2016 revision compare with other versions of the standard? In a new three-part video series, Walt Murray, MasterControl’s director of Quality and Compliance Consulting (QCC) services, walks through what, why, when and how changes are coming to the standard.

The first video in the series is available here.

There are presently three common versions of the standard: ISO 13485:2003 (the primary international standard), ISO 13485:2012 (the European harmonized version), and CAN/CSA ISO 13485:2003 (the Canadian equivalent of the 2003 version). Device manufacturers are justifiably concerned about how all three of these versions will migrate to the 2016 edition. Manufacturers also have a vested interest in knowing if the length time that will be allotted for executing any changes required for compliance to the standard (roughly a three-year span for previous ISO standard updates) will remain approximately the same.

Medical device companies are also anxious to find out how the new standard will align with what is being referred to as the High Level System (HLS), ISO’s latest methodology for drafting management system guidelines that is intended to foster greater compatibility among various management system standards and facilitate their integration and implementation by certified organizations. In the first installment of the video series, Murray delves into these concerns in more detail and explains the substantial impact that the updated standard will have worldwide. He also addresses the role that risk plays in the updated standard and explains how the forthcoming changes will affect manufacturers’ engagement in risk opportunity analysis and the potential improvements they can achieve through adherence to a closed-cycle orientation.

The first video in the series also features a discussion about delaying the release of the new edition of ISO 13485 until 2016 in order to determine how it would be affected by ISO 9001:2015 standard, which was published on Sept. 23, 2015. It is anticipated that ISO 13485 will adopt new elements, or at least components of those elements, in order to be absorbed into the high-level convention of the new ISO 9001 standard.


More ISO Videos

Stay tuned to MasterControl’s YouTube channel for parts two and three of the series, which will discuss the significant changes to ISO 13485 in greater depth.


James Jardine is a marketing communications specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.










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