实验室管理建立人员长期培训体系的初探和体会-中国药事.doc

PAGE 6 PAGE 7 作者简介：陈薇，主管药师，工程师;研究方向：药学信息、标准管理；E-mail:chenwei1102@126.com 标准查新和标准确认体系的建立对检验/检测机构的重要性 陈薇,桑彤,陆敏仪 （广西壮族自治区食品药品检验所，南宁 530021） 摘要 目的：探讨检验/检测机构标准查新和标准确认的管理模式。方法：根据我所检验（检测）/标准（方法）控制管理的实践经验，从标准库的建立与完善、标准变更确认管理、标准查新的落实与监督检查机制、工作中遇到的问题及解决方法等4个方面进行探讨分析。结果与结论：重视标准变更后的方法确认和方法验证工作；加强标准查新和标准确认管理，使其真正发挥预防措施的作用；主动关注和追踪国内、国际食品药品安全领域的重大事件和问题产品在国际上的技术检测标准，为决策层安排实验室新项目的扩项和配置足够的资源做准备，以真正做到满足社会大众和政府监管服务的要求。 关键词：CNAS认可；标准查新；标准确认；检验机构；实验室管理；检测质量控制 [中图分类号] R [文献标识码] [文章编号] The Importance of Establishing the System of Standard Novelty Search and Standard Confirmation for Inspection/Testing Institutes Chen Wei, Sang Tong and Lu Minyi （Guangxi Institute for Food and Drug Control, Nanning 530021，China） ABSTRACT Objective: To discuss the management model of standard novelty search and standard confirmation for inspection/testing institutions. Methods： According to our practical experience of the inspection (testing)/standard (method) control management, the following 4 aspects were discussed: the establishment and improvement of standard library; management of the confirmation for the standards changes; implementation and supervision system of standard novelty search; problems and solutions in work. Results and Conclusion：Institutes should pay more attention to validation and verification after standard changes, strengthen the management of standard novelty search and standard confirmation in order to exert the role of preventive measures, pay active attention and trace to the domestic and international important events in the field of food and drug safety, focus on the international technical inspection standards for the defective products, provide support and prepare for the decision makers who arrange expansion of new laboratory projects and allocate enough resources, in order to truly meet the requirements of the public and the government supervision service. KEY WORDS: CNAS accreditation; standard novelty search; standard confirmation；?inspection a