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Transitioning to ISO 13485:2016

Transitioning to ISO 13485:2016

In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach. This doesn’t mean that the traditional process approach has gone away, it means that risk management and risk analysis are going to play a greater role in how companies manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system. Read The New ISO 13485:2016 – Procrastination Can Cost You to learn more about the differences between the versions. What’s the Time Line for Transitioning to ISO 13485:2016? Ultimately, ISO 13485:2016 will replace ISO 13485:2003; however, over the course of the next three years (March 2016-2019), the standards will coexist. This will give manufacturers, notified bodies and regulators time to transition to the new standard. According to a transition planning guidance by ISO, organizations will be accredited for either edition for the first two years of the transition period. After the second year, new accreditation will only be given for ISO 13485:2016. After year three, any existing certification for ISO 13485:2003 will no longer be valid. In reality, this does not give you time to procrastinate. When you see the level of requirements you will have to account for, you will realize that taking necessary action should be a top concern. Preparing for the ISO 13485:2016 Transition Process Step 1: identify resources necessary to help implement the new standard Identify what will be needed (e.g. document review, gap...