GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes

Scope

This document specifies the quality management system requirements for organizations needing to demonstrate their ability to consistently meet customer requirements and applicable regulatory requirements for medical devices and related services. Such organizations may be involved in one or more stages of the medical device lifecycle, including the design and development, production, storage and distribution, installation or service, and the design and development or provision of related activities (such as technical support) for medical devices. This document can also be used by suppliers or external parties providing products (including services related to the quality management system) to such organizations. Unless specifically stated, the requirements of this document apply to organizations of all sizes and types. The requirements applicable to medical devices in this document 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 reduction of design and development controls, this can be used as a justification for their reduction 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 reduction in design and development controls is clearly stated in the declaration of compliance with this document. If any requirements in Chapters 6, 7, or 8 of this document are not applicable due to the nature of the organization's activities 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 any provisions determine

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