Bibliographic Details
| Title: |
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. (Chinese) |
| Alternate Title: |
Development and Application Research of a Laboratory Electronic Document Management System Based on ISO15189 Quality Management System Requirements. (English) |
| Authors: |
苏 泽, 孙晓琳, 宋 波, 吕承秀, 李 庆, 王 阳 |
| Source: |
Journal of Modern Laboratory Medicine; May2026, Vol. 41 Issue 3, p192-204, 7p |
| Subject Terms: |
Records management, Laboratory management, Records management software, Total quality management, Databases, Java programming language, Pathological laboratories, System analysis |
| Abstract (English): |
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 laboratory 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 integrated development environment. The application effect of the system was evaluated through questionnaires distributed to laboratory 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 reported 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. [ABSTRACT FROM AUTHOR] |
| Abstract (Chinese): |
目的 开发满足 ISO 15189 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 ISO 15189 的相关要求, 利用 MySQL 作为后端数据存储解决方 案, 使用 IntelliJ IDEA 集成开发工具, 配合 JDK 1.8 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 FROM AUTHOR] |
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Copyright of Journal of Modern Laboratory Medicine is the property of Journal of Modern Laboratory Medicine Editorial Department and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
Biomedical Index |