检测实验室如何应对ISO/IEC 17025:2017标准新要求的经验分享

Addressing the new requirements under ISO/IEC 17025:2017 by testing laboratories–Experience sharing

中文关键词:  实验室管理  风险和机遇  符合性声明  判定规则

英文关键词:laboratory management  risks and opportunities  conformity statement  decision rule

中文摘要:

      ISO/IEC 17025:2017标准引入风险为本的思维, 要求实验室考虑与其活动相关的风险和机遇, 并将应对措施整合到管理体系中。这包括识别风险、制定及实施适当的监控措施, 并评价其效能。同时, 2017年版的标准明确了报告符合性声明的要求, 包括实验室确定适用的规范或标准, 制定判定规则及考虑相关的风险水平, 并取得客户的同意。本文列举通过分析检测活动流程的例子, 从行政管理、样本处置到报告结果所涉的过程, 以及其他关联的实验室活动过程, 帮助检测实验室识别可影响检测结果的潜在风险, 接着利用矩阵半量化地因应风险水平分类。而有关判定规则方面, 本文介绍如何利用测量不确定度及保护间距, 判定检测结果是否符合适用的规范或标准, 考虑误判的机率, 并强调与客户沟通的重要性, 以期为实验室管理提供参考。

英文摘要:

      ISO/IEC 17025:2017 introduces risk-based thinking that requires a laboratory to consider risks and opportunities associated with laboratory activities, and to incorporate the actions to address risks and opportunities into the management system. This includes identification of risks, establishment and implementation of appropriate control measures, and evaluating the effectiveness. At the same time, the 2017 version defines the requirements for reporting statements of conformity, including laboratory to confirm the applicable specification or standard, establish decision rule and consider associated risk level, while obtaining agreement with the customer. This paper used a testing activity flowchart as example. Through analyzing the processes of the flowchart from administration and management, sample handling to reporting of test result and associated interrelated processes, it helped to identify the potential risks that might affect the test result. Subsequently, the risks were categorized according to the evaluation by a semi-quantitative matrix method. Regarding the decision rule, this paper discussed how to use measurement uncertainty and guide band to judge conformity of a test result against the applicable specification or standard as well as to consider the probability of false decisions. The importance of communication with the customer was emphasized, with a view to providing reference for laboratory management.