1. 中日友好医院 a. 医学工程处；b. 院办，北京 100029；2. 国家心血管病中心 中国医学科学院阜外医院，北京 100037
Application and Reliability of ISO 9000 Quality Management System in
Medical Equipment Management
LIN Yang1a, LI Tianqing2, GAO Min1a, GAO Haipeng1b
1. a. Department of Medical Agency; b. Department of Service, China-Japan Friendship Hospital, Beijing 100029, China;
2. Fuwai Hospital of Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, Beijing 100037, China
Abstract：Objective To explore the role and reliability of ISO 9000 quality system in medical equipment management. Methods A
total of 106 patients and doctors who received treatment in our hospital from January 2018 to February 2019 were selected to observe
and compare the equipment failure rate and normal utilization rate, patient satisfaction and doctor satisfaction, reconciliation rate
before and after the application of ISO 9000 quality management system. Results The normal utilization rate of equipment after the
application of ISO 9000 quality management system was 98.1%, which was significantly higher than that before the application of
ISO 9000 quality management system (86.8%) (P<0.05). The satisfaction of doctors and patients after the application of ISO 9000
quality management system was significantly higher than before the application of ISO 9000 quality management system (P<0.05).
The compliance rate (98.2%) of hospital equipment accounts after the adoption of ISO 9000 quality management system was
significantly higher than that before the application of ISO 9000 quality management system (91.7%, χ2
=5.621, P<0.05). Conclusion In
the process of hospital equipment management, adopting ISO 9000 quality management system can effectively reduce the failure rate
of equipment, improve the satisfaction of patients and doctors and the rate of reconciliation between accounts and objects.
林洋1a，李天庆2，高敏1a，高海鹏1b. ISO 9000质量管理体系在医疗设备管理中的应用及其可靠性探讨[J]. 中国医疗设备, 2020, 35(4): 106-108.
LIN Yang1a, LI Tianqing2, GAO Min1a, GAO Haipeng1b. Application and Reliability of ISO 9000 Quality Management System in
Medical Equipment Management. China Medical Devices, 2020, 35(4): 106-108.
