药品检测实验室确保计量溯源性的新增认可要求解析

Analyses of Added Accreditation Requirements on the Metrological Traceability in Medicinal Testing Laboratories

目的:确保药品检测实验室所获测量结果的计量溯源性可以持续满足实验室认可要求。方法:解读中国合格评定国家认可委员会(CNAS)发布新版《测量结果的计量溯源性要求》的关键历史背景,凸显该文件本次修订的重要意义,即国际单位制的重新定义,四大权威组织共同发布了新的关于计量溯源性联合声明,国际实验室认可合作组织(ILAC)修订了其计量溯源性政策文件,CNAS作为ILAC的正式成员按要求跟进修订。在此基础上将新旧两版文件的内容进行详细比对,并从新版文件的依据、范围、要求、表述与结构等方面对本次修订内容进行解析。结果与结论:利用梳理出的重点修订变化,结合药品检测实验室日常工作特点,为此类实验室持续满足认可要求提供了具有可操作性的体系运行和维护建议。同时也为其他类型的合格评定机构和评审员准确快速掌握该文件提供参考。

Objective:To ensure that the metrological traceability of the measurement results obtained by the medicinal testing laboratories can effectively meet the requirements of laboratory accreditation.Methods:To interpret the key historical contexts of the new version of “Metrological Traceability Requirements for Measurement Results” issued by China National Accreditation Service for Conformity Assessment(CNAS),and highlight the significance of this revision of the document,namely,the redefinition of the International System of Units.Four authoritative organizations issued the new joint declaration on metrological traceability.The International Laboratory Accreditation Cooperation(ILAC) revised policy on metrological traceability.As a formal member of ILAC,CNAS followed up the revisions as required.On this basis,comparing the contents of the new and old revisions of the document in detail,and the revised content was interpreted from the aspects of the basis,scope,requirements,expression and structure of the new version of the document.Results and Conclusion:Based on the key revisions and changes sorted out,combined with the characteristics of the daily work for medicinal testing laboratories,it provided on operable system operation and maintenance suggestions for such laboratories to continuously meet the accreditation requirements.Meanwhile,the suggestions for reference were provided to accurately and quickly comprehend the document for other types of conformity assessment institutions and reviewers.