Standard No.:	T/BSMIA 002-2025
English Name:	Evaluation Criteria for Chief Quality Officer (CQO) of Medical Devices
Chinese Name:	医疗器械首席质量官评价细则
Chinese Classification:	A00    Standardization and Quality Management
Professional Classification:	T/    Social Organization Standard
ICS Classification:	03.120.10 03.120.10    Quality management and quality assurance 03.120.10
Source Content Issued by:	Shanghai Association for Medical Devices Industry
Issued on:	2025-07-08
Implemented on:	2025-8-1
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了医疗器械首席质量官的评价对象、评价主体、评价指标、评价流程以及证书管理的要求。
本文件适用于医疗器械的设计和开发、生产、安装和服务以及经营等相关组织开展首席质量官的评价活动。