YY/T 0287-2017
Medical devices.Quality management systems.Requirements for regulatory purposes (English Version)

Standard No.

YY/T 0287-2017

Language

Chinese, Available in English version

Release Date

2017

Published By

Professional Standard - Medicine

Latest

YY/T 0287-2017

Replace

YY/T 0287-2003

Scope

This standard specifies quality management system requirements for organizations that need to demonstrate their ability to provide medical devices and related services that continue to meet customer requirements and applicable regulatory requirements. Such organizations can be involved in one or more stages of the medical device life cycle, including the design and development, production, storage and distribution, installation or servicing of medical devices, as well as the design and development or provision of related activities (such as technical support). This International Standard can also be used by suppliers or external parties that provide products (including services related to quality management systems) to such organizations. Unless expressly stated otherwise, the requirements of this standard apply to organizations of all sizes and types. The requirements in this standard that apply to medical devices also apply to related services provided by the organization. For processes required by this International Standard that are applicable to the organization but are not performed by the organization, the organization is responsible for monitoring, maintaining and controlling those processes in the quality management system. If applicable regulatory requirements permit the deletion of design and development controls, this may be grounds for deleting them from the quality management system. If these regulatory requirements provide for other methods, these methods should be described in the quality management system. It is the organization's responsibility to ensure that any deletions from design and development controls are identified in the statement of conformity to this standard. If any requirement in Chapters 6, 7 or 8 of this standard is not applicable due to the activities carried out by the organization or the characteristics of the medical devices covered by the quality management system, the organization does not need to include such requirements in its quality management system. For any provision that is determined to be inapplicable, the organization records its reasons in accordance with the requirements of 4.2.2.

YY/T 0287-2017 Referenced Document

• GB/T 19000-2016 Quality management systems—Fundamentals and vocabulary

YY/T 0287-2017 history

• 2017 YY/T 0287-2017 Medical devices.Quality management systems.Requirements for regulatory purposes
• 2003 YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
• 0000 YY/T 0287-1996