The new ISO 13485 standard did not adopt the High Level Structure of Annex SL used by other management system standards such as ISO 9001:2015 (quality), ISO 14001:2015 (environment), and ISO 27001:2003 (information security). The eight clause structure of ISO 13485:2003 (which matches ISO 9001:2008) has been carried over to ISO 13485:2016. 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. The new version of the standard includes improvements such as 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.
They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines, and even in vitro diagnostic reagents. A medical device is any product intended for use in the diagnosis, prevention, and treatment of medical conditions. With the standard applicable to so many types of products, the revision was no easy task. The new edition was issued to respond to the latest developments in quality management, technology, and regulatory requirements.
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes, sets out the requirements for a quality management system specific to the medical devices industry. The third edition of ISO 13485 has been published as the replacement for ISO 13485:2003.