ISO 13485 is a standard published by the International Organization for Standardization (ISO) which provides requirements for quality management systems (QMS) of companies involved in the medical device industry. It is based on the internationally recognized ISO 9001 QMS standard (which is not specific to any industry or type of product) and incorporates additional elements relevant to medical device processes.

ISO 13485 is set out to help medical device companies (primarily medical device manufacturers) set up a QMS that demonstrates consistent design, development, production, storage, distribution, installation, servicing, final decommissioning, and/or disposal of medical devices, as well as design and development, or provision of associated activities.

Many countries who develop their medical device regulations based on the International Medical Device Regulatory Forum (IMDRF) recommendations, rely on QMS compliance with ISO 13485 in their medical device requirements.