Subject and Scope:

ISO 13485:2016 specifies requirements for a quality management system when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet user requirements and applicable regulatory requirements.

Such organizations may be involved in one or more stages of the product lifecycle, including design and development, production, storage and distribution, installation, or servicing of medical devices, as well as design and development or provision of related activities (e.g., technical support).

ISO 13485:2016 can also be used by suppliers or external parties that provide products, including services related to the quality management system, to such organizations.