Medical devices——Quality management systems——Requirements for regulatory purposes

 
YY/T 0287-2017/ISO 13485: 2016
 
This standard specifies quality management system requirements for organizations that need to demonstrate their competence to provide medical devices and related services that continuously meet customer requirements and applicable regulatory requirements. Such organizations can cover one or more stages of the life cycle of medical devices, including the design and development, production, storage and circulation, installation or service of medical devices, and the design and development or provision of related activities (such as technical support). This standard can also be applied to suppliers or external parties that provide products (including services related to quality management systems) to such organizations.
 
Unless expressly specified, the requirements of this standard apply to organizations of all sizes and types. The requirements of this standard applied to medical devices also apply to related services provided by organizations.
 
For the processes required by this standard that are applicable to the organization but not implemented by the organization, the organization is responsible for monitoring, maintaining and controlling these processes in the quality management system.
Where applicable regulatory requirements allow for deletion of design and development controls, they can be justified in the quality management system. Where these regulations require other methods to be provided, these methods should be described in the quality management system. It is the responsibility of the organization to ensure that any deletions to design and development control are specified in the statement of compliance with this standard.