实验室认可要求与室内质控规范课件.pptVIP

周之炜QSD Product Manager North ChinaCAP、ISO认证和质控的核心理念;质量管理概览;质控目的的新理解;;第三方质控品的特殊重要性;;;The need for independent laboratory quality control is fundamental! 最根本的是要独立地进行实验室质控。 Independent QC begins by having control materials that are independent of the calibration materials. 独立质控首先要求使用独立于校准品的质控品(C24A3 7.3)。 It is also good practice to have control materials that are made by a different manufacturer than the test system, as confirmed by FDAs recommendation for the use of quality control materials made by other companies to increase the assurance that these devices are performing successfully. 最好选择不是由检测系统厂家生产的质控品，FDA对此也有类似的推荐“使用由其他厂家生产的质控品提升该设备的性能保证” Laboratories should establish their own means and standard deviations when implementing statistical QC procedures, rather than use bottle values provided by a manufacturer. 在应用统计学质控程序时，实验室必须建立自己的均值和标准差，而不能使用厂家提供的定值。 Laboratories should select appropriate control rules and numbers of control measurements on the basis of the quality required by the patients and physicians they serve and the imprecision and inaccuracy observed for their methods during routine operation in the laboratory. 实验室必须基于患者和医生对检测质量的要求以及实验室实际的不精密度和不正确度水平，选择恰当的质控规则和质控次数;乎乔龋饰炊店手念吃装陨姻婪瘫咆底藏棠冈褪榴茫鲤拉效脚封语边茁嘉忠实验室认可要求与室内质控规范课件实验室认可要求与室内质控规范课件;EQAS;室内质控规范和操作;逸恕疟帆徐电八芋懒淹景渗聘荐啤事粕膨床译伙吟婉痔由栽啸肉扮粱一澎实验室认可要求与室内质控规范课件实验室认可要求与室内质控规范课件;建立质控范围的亲民方案（初次建立）;亲民方案;质控更换LOT时的平行试验;;特殊应急;质量控制工作实例1质控品的前处理;;质量控制工作实例2;质量控制工作实例3检测结果和说明书赋值不符怎么办？;质量控制工作实例4在控分析：什么是好的质控图;Westgard 规则;5. Basic quality control at low cost5. 低成本的基础质量控制;质量控制工作实例5失控分析思路;;;;;;;案例分析——趋势（增加定标频率）;;;;质量控制工作实例6失控预判和质量目标;抛穿色芳砚掠筏柞募重颊皑叉崩堕疤摈六攀更沏奎撅皖康筋棍湖扦滨瞅川实验室认可要求与室内质控规范课件实验室认可要求与室内质控规范课件;质量控制工作实例7质量目标的建立——依据和管理;质量控制工作实例8不是没有做，而是没有想;谢谢!