TRAINING, CONSULTANCY
AND AUDIT SERVICES
FOR THE IMPLEMENTATION OF
MANAGEMENT SYSTEMS

The new version of ISO 13485 international standard (Medical devices – Quality management systems – Requirements for regulatory purposes) has just been published, as announced on the ISO official website.

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.

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.

ISO 13485:2016 is currently available from the ISO Store. It will also be available, in the near future, from the national standardization body (ASRO).

Source http://www.iso.org/.