Analysis of common defects in quality management system verification of medical device manufacturers and countermeasures
10.19745/j.1003-8868.2024159
- VernacularTitle:医疗器械生产企业质量管理体系核查常见缺陷分析与对策
- Author:
Si-Yuan LI
1
;
Chen YIN
;
Jian-Le CHEN
;
Yin-Ke SUO
Author Information
1. 陕西省药品和疫苗检查中心宝鸡分中心,陕西宝鸡 721013
- Keywords:
medical device manufacturer;
quality management system;
quality management system verification;
defect analysis
- From:
Chinese Medical Equipment Journal
2024;45(8):83-90
- CountryChina
- Language:Chinese
-
Abstract:
The quality management system verification of 67 medical device manufacturers in some region was introduced generally.The common defects during the quality management system verification of medical device manufacturerswere summarized from 11 aspects of organization and personnel,plant and facility,equipment,document management,design and development,procurement,production management,quality control and etc.The causes for the common defects were analyzed.Some countermeasures were proposed including strengthening the training and education of related personnel,continuously promoting quality management system,enhancing managment and execution mechanism and improving the mechanism of personnel participation and encouragement.References were provided for establishing and running the quality management system of medical device manufacturers.[Chinese Medical Equipment Journal,2024,45(8):83-90]
