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实验室ISO15189认可对学科建设的几点启示 被引量:121

The elicitation from laboratory accreditation for building medical laboratory sciences
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摘要 通过 ISO15189认可,可提高医学实验室质量管理水平,提高医疗质量,保证实验的精确性、准确性、可溯源性。笔者所在实验室在全国首家通过 ISO15189认可。笔者认为:(1)ISO15189的核心是建立全面质量管理体系;(2)分析前质量管理是认可准备的难点;(3)ISO15189定义实验室的功能拓宽了检验科工作的范围;(4)要从 ISO15189中认真学习先进的管理理念;(5)要将 ISO15189标准灵活应用于医学实验室;(6)注重参与、注重过程是"认可"收实效的关键。 ISO15189 accreditation helps improve quality management, including accuracy, precision and traceability, which are directly related to the quality of clinical practice. The author's lab was the first lab accreditated by ISO15189 in China. The author thinks: (1)The core concept of ISO15189 is to build total quality management system. (2) The pre-analytical phase is the most challenging part of the accreditation. (3) The ISO15189 defines a bigger scope of laboratory activity than that we are used to. The definition of medical laboratory in ISO15189 implies more job than before. (4) We have learned the advanced management theory from the accreditation. (5) ISO15189 should be flexibly used in medical laboratory. (6) Both participation of the staff and focusing the process in preparing for the accreditation have helped gain good results.
出处 《中华检验医学杂志》 CAS CSCD 北大核心 2007年第2期128-131,共4页 Chinese Journal of Laboratory Medicine
关键词 实验室 医院 诊断技术和方法 评价研究 全面质量管理 Laboratories,hospital Diagnostic techniques and procedures Evaluation studies Total quality management
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