ISO 13485:2016, the new international standard for Medical Devices – Quality Management Systems – requirements for regulatory purposes, has been revised and officially published 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 organizations 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 On site 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 organization, and how to implement them, so that you can get a step ahead of the competition in making an effective transition.”
LRQA’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 for those with knowledge of either ISO 13485:2003 or EN ISO 13485:2012 and who are responsible for coordinating the transition of their management system to the revised standard. This course also introduces the role of MDSAP.
- ISO 13485:2016 Appreciation and Interpretation, provides an introduction to the new standard for those who have had no previous training on ISO 13485.
Through our extensive range of training and assessment services, LRQA is helping organizations worldwide transition to the new and revised ISO standards. For more information about ISO 13485:2016, email email@example.com or visit www.lrqausa.com.