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.

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 organization's quality management system by monitoring, maintaining, and controlling the processes


ISO 9001 Quality ISO 17025 Laboratory ISO 21001 Education ISO 29990- 29993 Learning & Development ISO 13485 Medical Devices ISO 15189 Medical Laboratory ISO 10000 Series Customer Satisfaction ISO 30301 Records/Document ISO 18404 Lean Six Sigma ISO 21500 Project Management ISO 20700 Management Consultancy ISO 16949 Automotive Quality Management JCI Accreditation
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