YY/T 0287-2017: Translated English of Chinese Standard. (YYT 0287-2017, YY/T0287-2017, YYT0287-2017): Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (ISO 13485:2016, IDT)

This Standard 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 development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, 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 Standard or can be required by contract to conform.