作为国家重点发展的高新技术服务行业，检测认证始终支撑着国家质量工程的基础 设施建设。2017 年IECEE 国际电工委员会正式作废已连续使用十余年的 ISO 17025:2005 版标准，取而代之的是包含风险管理硬性要求的新版 17025。由于体系标准换版的过渡 期，虽然已有学者就关注体系改进带来的经济效益进行了相关研究，但忽略了实际检测 环节中，风险带来的结果质量影响。SC 检测实验室是一家代表着华南区产品安全质量 水平的检测机构，同时也是本次换版浪潮中的典型，体系运行至今虽未出现重大质量事 故，但问题偏差终年不断，甚至不定期重复发生，非常不利于实验室今后高水平高质量 的长远发展。 本文通过查阅整理大量的文献资料，对业内目前风险管理现状的介绍；比较分析新 旧版体系要求差异带来的影响；重点识别研究案例实验室外部评审不符合项、检测报告 质量和测量不确定度评估三个关键环节的风险并进行分析。在此基础上，运用项目风险 管理理论的半定量（技术绩效测量）和定性（偏差趋势分析和储备分析）风险分析工具， 结合检测过程实际资源的安排，设置风险管理程序，制定相关风险控制措施。在完成落 实相关的制度措施后，进行实地内审，验证风险控制措施的效果。采用层次分析法建立 评价指标体系，结合模糊评价方法，得出实验室体系风险值，综合评估实验室风险控制 的状态。总结归纳针对检测风险管理的合理性建议。 关键词：检测认证；风险控制；管理体系；报告质量；测量不确定度II Abstract As a national development priority of high-tech service industry, testing certification has always supported the infrastructure construction of national quality engineering. The IEC System for Conformity Testing and Certification of Electrical Equipment had officially abolished the standard ISO 17025 of version 2005 in 2017, which had been in use for more than a decade, and replaced with a new version which contains rigid requirements for risk management. In virtue of the transition period of the system standard change, some scholars have carried on the related research to pay attention to the economic benefit brought by the system improvement, but has ignored the quality influence of the risks from the actual system links. SC testing lab is a testing organization representing the level of product safety and quality in South China which is typical of this wave of standard change. The quality management system (QMS) of the lab has been running well and no major quality accidents have occurred, but the minor problems and deviations are constantly emerging, even tautologically and irregularly. It is very detrimental to the long-term development of laboratory in the future. This paper introduces the current situation of risk management in the industry by consulting and collating a large number of documents. According to the comparative analysis of the impact of the requirements differences in both the new and old version systems, focus on identifying the risk of three key links: non-conformity report in external assessments, quality of test report and evaluation of measurement uncertainty. On this basis, utilizing semi-quantitative (technical performance measurement) and qualitative (bias trend analysis and reserve analysis) risk analysis tools from project risk management theory, establishing a risk management procedure, developing relevant risk control measures combines with the actual resources during the testing process. At length, an internal audit shall verify the validation of measures to induce reasonable suggestions. Key words: Testing and certification; Risk management; QMS; Quality of testing report; measurement uncertaintyIII 目 录 摘要...........................................................................................................................................I Absract....................................................................................................................................... II 图表目录..................................................................................................................................VI 第一章 绪论...............................................................................................................................1 1.1 选题背景及意义..............................................................................................................1 1.2 文献综述..........................................................................................................................2 1.2.1 质量管理理论的发展................................................................................................2 1.2.2 风险管理理论的发展................................................................................................3 1.2.3 国内外研究现状........................................................................................................5 1.3 研究方法和内容..............................................................................................................7 1.3.1 研究方法....................................................................................................................7 1.3.2 技术路线....................................................................................................................8 1.3.3 研究内容....................................................................................................................9 第二章 检测认证（TIC）风险管理基础环境......................................................................10 2.1 TIC 行业国家法律法规的新重点..................................................................................10 2.1.1 《国家标准化法》等新版法规条例的概述..........................................................10 2.1.2 新版 CNAS 实验室认可规范的概述.....................................................................11 2.1.3 新版 CMA 资质认定管理办法的概述...................................................................11 2.2 开放市场下 TIC 行业环境的发展与变化....................................................................11 2.2.1 国家“一带一路”战略背景下的影响..................................................................12 2.2.2 TIC 行业质量管理体系应用的发展.......................................................................12 2.2.3 ISO 9000 标准体系与 ISO 17025 标准体系的区别与联系...................................13 2.3 新旧版 ISO 17025 体系标准的比较分析.....................................................................14 2.3.1 新旧版 ISO 17025 标准差异..................................................................................15 2.3.2 旧版“改进”要素与新版“风险控制”要素之间的比较分析.................................. 16 2.4 本章小结........................................................................................................................16 第三章 SC 检测实验室体系关键环节风险识别...................................................................17 3.1 SC 实验室基本情况.......................................................................................................17IV 3.1.1 SC 实验室体系架构及资源情况.............................................................................17 3.1.2 SC 实验室风险控制关键环节.................................................................................19 3.2 SC 实验室历年外部评审不符合项（NCR）实例汇总分析.......................................19 3.2.1 SC 实验室历年外部评审 NCR 实例概述.............................................................. 19 3.2.2 SC 实验室历年外部评审 NCR 风险识别.............................................................. 19 3.3 行业强制性产品检测质量及 SC 实验室报告问题汇总分析.....................................22 3.3.1 强制性产品质量检测情况......................................................................................22 3.3.2 SC 实验室检测报告质量风险识别.........................................................................22 3.4 SC 实验室测量不确定度评估的风险影响分析...........................................................25 3.4.1 贝叶斯定理..............................................................................................................25 3.4.2 合格判定..................................................................................................................25 3.4.3 SC 实验室接地试验不确定度评定风险识别.........................................................27 3.5 本章小结........................................................................................................................29 第四章 SC 检测实验室风险控制程序与管理措施...............................................................30 4.1 项目管理知识体系（PMS）风险管理工具................................................................30 4.1.1 偏差和趋势分析......................................................................................................30 4.1.2 技术绩效测量..........................................................................................................31 4.1.3 储备分析..................................................................................................................31 4.2 SC 实验室风险管理程序的设置...................................................................................32 4.2.1 体系风险因素..........................................................................................................32 4.2.2 风险评估..................................................................................................................34 4.2.3 风险处置..................................................................................................................34 4.2.4 风险监控..................................................................................................................34 4.3 SC 实验室体系关键环节的风险控制措施...................................................................35 4.3.1 已关闭不符合项的跟踪评估..................................................................................35 4.3.2 检测报告质量的保证..............................................................................................36 4.3.3 测量不确定度评估的应用......................................................................................37 4.4 SC 实验室体系风险分析及应对策略...........................................................................38 4.5 本章小结........................................................................................................................39 第五章 SC 检测实验室风险控制效果验证评价...................................................................40V 5.1 自查方案和自查内容....................................................................................................40 5.2 自查结果........................................................................................................................41 5.2.1 实验室组织机构情况..............................................................................................41 5.2.2 质量体系整体运行情况..........................................................................................41 5.2.3 检测流程合规性情况..............................................................................................41 5.2.4 从业人员职业自律情况..........................................................................................42 5.2.5 自查不符合整改......................................................................................................42 5.2.6 电线电缆业务专项核查..........................................................................................43 5.3 SC 实验室风险控制效果评价.......................................................................................44 5.3.1 建立效果评价体系..................................................................................................44 5.3.2 计算实验室管理体系风险值..................................................................................50 5.4 本章小结........................................................................................................................52 结 论.........................................................................................................................................53。。。。。。以下内容略