ISO 13485:2016 (Medical Devices – Quality Management Systems)

ISO 13485:2016 certification services is for medical device manufacturers who are looking to realize or establish consistent supplier quality, clear best practices for design, and efficient manufacturing and distribution programs.

ISO 13485 certification specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and progress, manufacture, storage and distribution, installation, servicing and final decommissioning and dumping of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, sub assemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform.