[1]苏 泽,孙晓琳,宋 波,等.基于ISO15189质量管理体系要求的实验室电子文档管理系统的开发及应用研究[J].现代检验医学杂志,2026,41(03):192-197+204.[doi:10.3969/j.issn.1671-7414.2026.03.035]
　SU Ze,SUN Xiaolin,SONG Bo,et al.Development and Application Research of a Laboratory Electronic Document Management System Based on ISO15189 Quality Management System Requirements[J].Journal of Modern Laboratory Medicine,2026,41(03):192-197+204.[doi:10.3969/j.issn.1671-7414.2026.03.035]
点击复制

基于ISO15189质量管理体系要求的实验室电子文档管理系统的开发及应用研究()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第41卷
期数:
2026年03期
页码:
192-197+204
栏目:
质量控制 实验室管理
出版日期:
2026-05-13

文章信息/Info

Title:
Development and Application Research of a Laboratory Electronic Document Management System Based on ISO15189 Quality Management System Requirements
文章编号:
1671-7414（2026）03-192-07
作者:
苏 泽，孙晓琳，宋 波，吕承秀，李 庆，王 阳
淄博市第一医院，山东淄博 255200
Author(s):
SU Ze，SUN Xiaolin，SONG Bo，LYU Chengxiu，LI Qing，WANG Yang
Zibo First Hospital, Shandong Zibo 255200, China
关键词:
国际标准化组织15189; 文件控制; 实验室质量管理体系; 电子文档管理系统
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2026.03.035
文献标志码:
A
摘要:
目的?开发满足ISO15189质量管理体系要求的实验室电子文档管理系统，并探讨电子文档管理系统（以下简称系统）用于提高实验室文件管理效率的可行性。方法基于ISO15189的相关要求，利用MySQL作为后端数据存储解决方案，使用IntelliJIDEA集成开发工具，配合JDK1.8和Java编程语言进行系统开发，构建系统，通过向实验室员工发放调查问卷评价该系统的应用效果。结果该系统现存960份内部文件和803份外部文件，可作为检验知识库供工作人员查阅学习。采用权限控制的方式，检验科员工均可以进行文件的修订，授权专业技术负责人进行文件的审核、批准，文控主管进行文件的发布，旧文件通过系统废止进入历史文件。所有文件均具有统一的格式和唯一的识别码。系统可即时提醒各级相关负责人完成需要执行的任务，操作完成后自动形成完整详细的电子记录，保证了文件的唯一性、可溯性、规范性。分别对系统和纸质文件使用的满意度进行调查问卷，结果显示，在文件获取、阅览文件内容、查找文件用时、修改文件效率、审批文件、识别文件的唯一性标识、防止误用废止文件、保证科室所用的记录表格为最新版本、文件评审期间效率、获取外部文件以及外部文件更新等方面，电子文档管理系统均要优于纸质文件，且两者差异具有统计学意义（χ2=42.965~80.807，均P<0.001）；另有10.42%的员工反馈登录电子文档管理系统的密码过于繁琐，容易忘记。结论电子文档管理系统可实现ISO15189关于文件控制的要求，方便员工学习和充分利用实验室的质量体系文件开展检验工作。
Abstract:
Objective To develop an electronic document management system for laboratories compliant with the requirements of ISO15189 quality management system, and to explore the feasibility of applying this system to enhance the efficiency of labora-tory document management. Methods Based on the relevant requirements of ISO15189, this study developed a system using Java programming language with JDK 1.8, employing MySQL as the back-end data storage solution, and IntelliJ IDEA as the in-tegrated development environment. The application effect of the system was evaluated through questionnaires distributed to labo-ratory staff. Results The system currently manages 960 internal documents and 803 external documents, which can serve as a testing knowledge base for staff consultation and learning. Through authority control, clinical laboratory employees are allowed to revise document, authorized professional and technical persons in charge are responsible for document review and approval, document control supervisors conduct document release, and the obsolete documents are invalidated via the system and archived as historical records. All documents have a unified format and a unique identification code. The system can instantly remind the relevant persons in charge at all levels to complete required tasks, and complete and detailed electronic records are automatically generated after operation, ensuring the uniqueness, traceability and standardization of documents. Questionnaire surveys were conducted to compare satisfaction with the system and paper-based documents. The results of the questionnaire surveys showed that the electronic document management system was significantly superior to paper documents in terms of document acquisition, document reading, search time, convenient and efficient document modification, simplified document approval, identification of unique document identifiers, prevention of misuse of invalid documents, assurance of the latest version of record forms used in the department, higher efficiency during document review, easier access to external documents, and timely updates to external documents, with statistically significant differences (χ2=42.965~80.807, all P<0.001). In addition, 10.42% of the employees re-ported that the password for logging into the electronic document management system was too cumbersome and easy to forget.Conclusions The electronic document management system can fulfill the requirements of ISO 15189 for document control, facilitating staff in learning and making full use of the laboratory quality management system documents to conduct clinical laboratory work.

参考文献/References:

[1] 丛玉隆,邓新立.实验室ISO 15189认可对学科建设的几点启示[J].中华检验医学杂志,2007,30(2):128-131. CONG Y L, DENG X L. The elicitation from laborato-ry accreditation for building medical laboratory scienc-es[J]. Chinese Journal of Laboratory Medicine, 2007, 30(2): 128-131.
[2] International Organization for Standardization. ISO 15189: 2012, medical laboratories - requirements for quality and competence[EB/OL].(2012-11)https://www.iso.org/standard/56115.html.
[3] 邱宁.NET架构下实验室文档管理系统的设计与实现[J].浙江树人大学学报(自然科学版), 2007, 7(3):19-22. QIU N. Design and implementation of the management system for lab documents under the NET framework [J]. Journal of Zhejiang Shuren University(Acta Scien-tiarum Naturalium), 2007, 7(3): 19-22.
[4] 欧阳能良,王伟佳,黄福达,等.临床实验室质量管理系统的建立与应用[J].中国数字医学,2019,14(2):16-18. OUYANG N L, WANG W J, HUANG F D, et al. Es-tablishment and application of management system for quality in clinical laboratory[J]. China Digital Medi-cine, 2019, 14(2): 16-18.
[5] 段学成,周婷婷,刘明珠,等.医学实验室质量管理体系文件控制与改进分析[J].中国卫生产业,2019,16 (19):43-44.
[6] 韩心远,阚丽娟,陈大洋,等.临床实验室标准化电子文档管理系统的研发与应用[J].临床检验杂志,2022, 40(2):150-154. HAN X Y, KAN L J, CHEN D Y, et al. Development and application of standardized electronic document manage-ment system in clinical laboratory[J]. Chinese Journal of Clinical Laboratory Science, 2022, 40(2): 150-154.
[7] 吉建民.一种临床实验室管理系统:CN202011019650.2 [P].CN112086148A[2020-12-15]. JI J M. A clinical laboratory management system:CN202011019650.2 [P]. CN112086148A [2020-12-15]
[8] SILVERSTEIN M D .An approach to medical errors and patient safety in laboratory services a white paper, prepared for the quality institute meeting making the laboratory a partner in patient safety Atlanta, April 2003, division of laboratory systems centers for disease con-tro[J].Atlanta, 2003. https://www.researchgate.net/publi-cation/237739475
[9] BEYANGA M, GERWING-ADIMA L, JACKSON K, et al. Implementation of the laboratory quality management system (ISO 15189): Experience from bugando medical centre clinical laboratory - mwanza, tanzania[J]. African Journal of Laboratory Medicine, 2018, 7(1): 657.
[10] 崔西勇,尹峰,郭亚丽,等.检验检测机构文件控制的标准化探讨[J].实验室研究与探索,2022,41(10):256-259, 269. CUI X Y, YIN F, GUO Y L, et al. Discussion on stan-dardization of document control in inspection and testing institutions[J]. Research and Exploration in Laboratory, 2022, 41(10): 256-259, 269.
[11] 中华人民共和国国家卫生健康委员会.国家卫生健康委办公厅关于贯彻落实职业卫生技术服务机构管理办法的通知[EB/OL]. (2020-12-31)[2021-02-01] https://zwfw.nhc.gov.cn/kzx/tzgg/zywsjsfwjgzzrksp_232/202101/t20210125_2035.html.National Health Commission of the People’s Republic of China. Circular of the General Office of the National health commission on implementing the administrative measures for occupational health technical service insti-tutions[EB/OL]. (2020-12-31)[2021-02-01] https://zwfw. nhc.gov.cn/kzx/tzgg/zywsjsfwjgzzrksp_232/202101/t20210125_2035.html.
[12] 陆碧茹,丁灿华,肖惠贞.疾控中心内审结果分析与改进[J].中国卫生质量管理,2010,17(6):101-103. LU B R, DING C H, XIAO H Z. Results from CDC internal audit and strategy for improvement[J]. Chinese Health Quality Management, 2010, 17(6): 101-103.
[13] 朱娜.高校分析测试中心质量管理的实践探索[J].实验技术与管理,2021,38(6):26-29. ZHU N. Practice and exploration of quality management of instrumental analysis center in colleges and univer-sities[J]. Experimental Technology and Management, 2021, 38(6): 26-29.
[14] 敬海峰,宇博,王云志,等.高校检验检测机构质量管理对策研究[J].实验技术与管理,2020,37(6):34-38. JING H F, YU B, WANG Y Z, et al. Research on strat-egy of quality management in inspection and testing institutions in colleges and universities[J]. Experimental Technology and Management, 2020, 37(6): 34-38.
[15] 张健,胡冬梅,李军燕,等.从医学实验室认可的不符合项探析当前医学实验室的质量管理现状[J].中华检验医学杂志,2015,38(6):421-423. ZHANG J, HU D M, LI J Y, et al. Analysis of nonconfor-mities in medical laboratory accreditation and status quo of clinical laboratory quality management[J]. Chinese Journal of Laboratory Medicine, 2015, 38(6): 421-423.
[16] 张志强,王新锋. ISO15189质量管理体系不符合项分析及改进[J]. 中国卫生检验杂志,2014,24(9):1354-1355. ZHANG Z Q, WANG X F. Analysis and improvement of nonconformities in the ISO 15189 quality management system[J]. Chinese Journal of Health Laboratory Tech-nology, 2014, 24(9): 1354-1355.

备注/Memo

备注/Memo:
作者简介：苏泽（1993-），女，在读硕士，主管技师，研究方向：生化与免疫检验及实验室文件控制，E-mail：suze08@163.com。
通讯作者：王阳（1981-），男，大学本科，副研究员，研究方向：医院管理，E-mail：20788038@qq.com。
更新日期/Last Update: 2026-05-15