ISO 13485:2016 is a standard developed by the International Organization for Standardization, which can be used by any organization irrespective of its type or size, involved in any stages of the life-cycle of medical devices including design and development, production, storage and distribution, installation or servicing or provision of associated activities.

ISO 13485 represents the requirements for a comprehensive management system for the design and manufacturing of medical devices. While this is a stand-alone standard, it is based on ISO 9001:2008, which has been superseded by ISO 9001:2015. Moreover, compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.

This standard can provide organizations with a framework to implement and maintain a quality management system. The QMS will enable organization to control, monitor and improve their processes and reliably provide products or services that achieve customer satisfaction and comply to regulatory regulations.