YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes

Scope

This standard specifies the requirements for a quality management system for organizations that need to demonstrate their ability to provide medical devices and related services that continuously meet customer requirements and applicable regulatory requirements. Such organizations may involve one or more stages of the medical device life cycle, including the design and development of medical devices, production, storage and distribution, installation or service, and the design and development or provision of related activities (such as technical support). This standard can also be used by suppliers or external parties who provide products (including services related to the quality management system) to such organizations.
Unless specifically stated, the requirements of this standard apply to organizations of all sizes and types. The requirements applied to medical devices in this standard also apply to the related services provided by the organization.
For processes 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.
If applicable regulatory requirements allow for the deletion of design and development controls, this can be used as a reason to delete them in the quality management system. If these regulatory requirements provide alternative methods, these methods should be described in the quality management system. The organization is responsible for ensuring that any deletions of design and development controls are clearly stated in the declaration of compliance with this standard.
If any requirements in Chapters 6, 7, or 8 of this standard are not applicable due to the activities carried out by the organization or the characteristics of the medical devices involved in the quality management system, the organization does not need to include such requirements in its quality management system. For

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