ISO 13485:2016 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices.

The latest version of the standard, was published in March 2016. It shares the same QMS principles and also follows the general increased emphasis on risk management shown within the range of QMS standards. It has not, however, adopted the Annex SL high level structure reflected within ISO 9001:2015.

ISO 13485 was originally derived from ISO 9001 and shared the same basic principles, but required greater documentation and placed additional emphasis on areas such as the work environment, risk management, design control and regulatory requirements.