The International Organization for Standardization (ISO) published the updated ISO 13485 medical devices quality management systems standard on March 1, 2016.
ISO 13485:2016 identifies the requirements for a quality management system (QMS) in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. Organizations seeking certification may be involved in any portion of the medical device product lifecycle, which includes design and development, production, storage and distribution, installation, or servicing of a medical device or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, materials or service, including quality management system-related services to such organizations.