EVS-EN ISO 13485:2016+A11:2021

ISO 13485 is an international standard that specifies the requirements of a quality management system for medical devices. The adoption of a quality management system is a strategic decision of an organization. It can be used to demonstrate the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 can be used by organizations that are 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 can also be used by suppliers or external parties that provide products, including quality management system-related services. The supplier or external party can voluntarily choose to conform to the requirements of the standard or can be required by contract to conform. Requirements of  ISO 13485 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 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. EN ISO 13485:2016/A11:2021 supports the requirements of EU Regulations. The relationship with EU Regulations can be found in informative annexes. The text of ISO 13485:2016 has been approved in Europe as EN ISO 13485:2016 without any changes and it supersedes EN ISO 13485:2012 and CEN ISO/TR 14969:2005.