浅析医疗器械生产质量管理体系文件系统的建立与管理

摘要

The objectives of QMS for quality assurance of products are achieved by formulation,implement, and management of document system. Document (includes record) system is important constituent part of QMS. In this paper, the important issues and relative requirements of GMP on the establishment and management of documentation within quality management system (QMS) of medical device enterprises are discussed with the aim of providing reference for relative enterprises to build and improve their QMS and to implement GMP.%质量管理体系对产品质量保证的目标是通过文件系统的建立、执行、和管理得以实现的，文件（包括记录文件）是质量管理体系的核心组成部分。该文对医疗器械GMP对质量管理体系文件系统的建立与管理的重要方面和要求进行了分析探讨，供医疗器械生产企业建立和完善质量管理体系并实施医疗器械GMP时参考。