ISO 15189:2012 和ISO 15189:2022 的不符合对照分析及换版策略
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Comparison analysis of nonconformities and strategy of change version for ISO 15189: 2012 and ISO 15189: 2022
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    摘要:

    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。

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    Abstract: 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 151 89 :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 noncon-formities ( range from 8 to 31) were identified in every on-site audit. Most of them were related to ISO 15189 :2022 clauses 7.3 Exami-nation 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.

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何菁,胡长爱,杨大干. ISO 15189:2012 和ISO 15189:2022 的不符合对照分析及换版策略[J].临床检验杂志,2024,42(4):304-307

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  • 收稿日期:2023-09-11
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  • 在线发布日期: 2024-06-14
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