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ISO 13485:2016

Medical Devices Quality Management System



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.

Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard

 published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and

 manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the

 previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996)


The current ISO 13485 edition was published on 1 March 2016.[1]


Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization

, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organizations quality management system by monitoring, maintaining, and controlling the processes.