ISO 13485:2016 specifies requirements for a quality management system where an organization
needs to demonstrate its ability to provide medical devices and related services that
consistently meet customer and applicable regulatory requirements. Such organizations
can be involved in one or more stages of the life-cycle, including design and development,
production, storage and distribution, installation, or servicing of a medical device
and design and development or provision of associated activities (e.g. technical support).
ISO 13485:2016 can also be used by suppliers or external parties that provide product,
including quality management system-related services to such organizations.