ISO 15189:2012和ISO 15189:2022的不符合对照分析及换版策略  

Comparison analysis of nonconformities and strategy of change version for ISO 15189:2012 and ISO 15189:2022

作　　者：何菁 胡长爱[2] 杨大干[2] HE Jing;HU Changai;YANG Dagan(Department of Laboratory Medicine,Affiliated Hospital of Shaoxing University,Shaoxing 312000,Zhejiang;Department of Laboratory Medicine,the First Affiliated Hospital,College of Medicine,Zhejiang University,Hangzhou 310003,Zhejiang,China)

机构地区：[1]绍兴文理学院附属医院检验科,浙江绍兴312000 [2]浙江大学医学院附属第一医院检验科,杭州310003

出　　处：《临床检验杂志》2024年第4期304-307,共4页Chinese Journal of Clinical Laboratory Science

摘　　要：目的通过分析ISO 15189:2012与ISO 15189:2022版标准的不符合项,为实验室换版工作提供改进策略。方法收集24家实验室32次现场评审的522项ISO 15189:2012不符合项目,并将其对应到ISO 15189:2022版标准的相关条款。基于标准要求、文献研究和实验室现状,探讨ISO 15189换版的工作策略。结果每次现场评审平均16条不符合项,最少8条,最多31条。这些不符合项主要集中在ISO 15189:2022版7.3检验过程(165条)、6.5设备校准和计量学溯源(43条)、6.6试剂和耗材(40条)等条款要求。而对于风险管理、患者相关要求、即时检验等新增或加强的条款要求,不符合项相对较少。结论ISO 15189:2022版标准的不符合项主要集中在检验过程环节,建议实验室利用数字化、智能化技术手段,加强这一环节的管理,以顺利实施新版标准要求,并通过组织培训、差距分析、文件修订、全员参与实施、加强风险管理和持续改进等策略,确保换版工作的顺利推进。Objective To analyze nonconformities between 2012 and 2022 version of ISO 15189,and provide strategies of transitioning to new standard for laboratories.Methods A total of 522 nonconformities from 32 on-site audits in 24 laboratories against ISO 15189:2012 were collected and mapped them to the relevant clauses of ISO 15189:2022.Strategies for transitioning ISO 15189 to new version were explored based on the standard requirements,literature review and current laboratory practices.Results On average,16 nonconformities(range from 8 to 31)were identified in every on-site audit.Most of them were related to ISO 15189:2022 clauses 7.3 Examination Processes(165 nonconformities).The others were clause 6.5 Equipment Calibration and Metrological Traceability(43)and clause 6.6 Reagents and Consumables(40).Relatively fewer nonconformities involved new/enhanced requirements,such as risk management,patient-related processes and point-of-care testing.Conclusion The main nonconformities in ISO 15189:2022 predominantly involved in the link of examination processes.It should be suggested that the laboratories strengthen the management in this area by adopting digital/intelligent technologies in order to smoothly implement the requirements of the new version of ISO 15189:2022 standard.A comprehensive strategy,including incorporating training,gap analysis,document revision,implementation involved in all staff,stringent risk management and continuous improvement should be recommended to ensure successful transition progress for replacement of ISO 15189:2022.

关 键 词：医学实验室 认可 不符合项 风险管理 ISO 15189:2022 

分 类 号：R446.9[医药卫生—诊断学]