ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.
With the standard applicable to so many types of products, the revision was no easy task. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and even in vitro diagnostic reagents.
Improvements in the new version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements and a greater focus on post-market surveillance including complaint handling.
There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.
Wil Vargas, Secretary of ISO/TC 210, the technical committee responsible for the revision, managed by ANSI, ISO's member for the USA, said the new version will provide even greater confidence to stakeholders, including consumers.
“Not only will it allow organizations to demonstrate compliance with regulatory requirements, but it will help all organizations involved in the development, distribution and maintenance of medical devices improve their processes, better manage risks and ultimately improve the quality of what they do.”
Organizations certified to ISO 13485:2003 wishing to transition to the new version can get guidance from the standard's Transition Planning Guidance [PDF] document.
ISO 13485:2016 is available from your ISO national member or from the ISO Store.
Learn more about the changes in this short interview with Eamonn Hoxey.