Establishment and Management of Documentation within QMS of Medical Device Enterprises
10.3969/j.issn.1671-7104.2013.05.015
- VernacularTitle:浅析医疗器械生产质量管理体系文件系统的建立与管理
- Author:
Shaolei TIAN
1
Author Information
1. 国家食品药品监督管理总局药品认证管理中心
- Keywords:
medical device;
QMS;
GMP;
document;
record;
formulation;
management
- From:
Chinese Journal of Medical Instrumentation
2013;(5):358-361
- CountryChina
- Language:Chinese
-
Abstract:
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.
