ISO 13485: 2016
ISO 13485:2016 specifies requirements for a quality management system of an organization that needs to demonstrate its ability to provide medical devices and related services and 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. ISO 13485:2016 can also be used by suppliers or external parties that provide products, such as quality management system-related services to such organizations. It is thus the basis for companies that are in the field of medical technology.
The list below represents the main processes and procedures required by the ISO 13485:2016. The second column lists all of the affected chapters of ISO 13485:2016 for additional information. The third column shows if the new medical device regulation could have some additional impact on these processes and procedures or not.