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ISO 13485:2016: Medical Devices QMS standard published by ISO.

ISO 13485:2016, the new international standard for Medical Devices – Quality Management Systems – requirements for regulatory purposes, has been revised and officially published today by the International Organization for Standardization (ISO). The revision has been undertaken to reflect changes in the medical devices industry, regulatory requirements and the quality management arena.

“The revised standard is applicable to all organisations involved in the life cycle of the medical device, from concept to disposal,” said LRQA’s Technical Manager – Medical Devices, John Howlett. “Greater focus has been placed on the role of top management, control of suppliers and outsourced activities and risk management.”

To support medical device manufacturers and related suppliers with their transition to the revised standard, LRQA provides a range of medical devices training courses which cater to different groups of quality management personnel, and these can be delivered either in-house or as public courses. “The publication of ISO 13485:2016 is a great step forward for the medical devices industry, ensuring quality and safety in an ever changing field,” said Alan To, LRQA Vice-President, Global Strategic Marketing. “LRQA’s ISO 13485:2016 training courses will help you to understand what the changes mean for your organisation, and how to implement them, so that you can get a step ahead of the competition in making an effective transition.”.

LR’s training courses include:

  • ISO 13485:2016 Update Workshop, gives an overview of the new and revised areas of the standard.

  • Preparing for ISO 13485:2016, has been developed to cater for the learning needs of those with knowledge of either ISO 13485:2003 or EN ISO 13485:2012, who are responsible for co-ordinating the transition of their management system to the revised standard.

Through our extensive range of training and assessment services, LR is helping organisations worldwide transition to the new and revised ISO standards. 

Please note that as of January 2018, we have moved to the Lloyd's Register brand and retired the LRQA name.

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