
戴明环循环法在Ⅰ期临床药动学实验室质量管理中的应用
Application of PDCA Method in Improving Quality System of Phase Ⅰ Labs
目的 本研究结合戴明环(PDCA)法,阐述Ⅰ期实验室质量管理体系持续改进的基本流程。方法 结合Ⅰ期实验室的具体情况,分别从体系运行层面以及项目开展层面研究戴明环工具的具体运用。结果 戴明环法作为一种管理工具,与ISO 17025质量管理体系目标一致,都可以促使Ⅰ期实验室质量管理体系不断完善。结论 戴明环循环法在实现Ⅰ期实验室质量目标的过程中,有非常重要的意义,可保障Ⅰ期实验室检测结果的准确、可靠。
OBJECTIVE To describe the continuous improvement process of the quality system of phase I labs by using(plan-do-check-action) PDCA method. METHODS Considering the particular characteristics of phase I labs, PDCA cycle was applied to the quality management system as well as the research programs. RESULTS As a quality management tool, PDCA method holds the same goal as ISO 17025 system, that is, to improve the management system of phase I labs. CONCLUSION PDCA method is very useful in helping phase I labs achieve the quality goals, which, as a result, can ensure the accuracy and reliability of the research results.
Ⅰ期实验室 / 戴明环循环 / 质量管理 {{custom_keyword}} /
phase I lab / PDCA cycle / quality management {{custom_keyword}} /
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