抽样的不确定度- ISO/IEC 17025(2017)的要求是否可以在医学实验室中采用?

Q2 Nursing

International Journal of Reliable and Quality E-Healthcare Pub Date : 2022-01-01 DOI:10.4018/ijrqeh.295082

K. Tsimillis, Sappho Michael

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引用次数: 1

摘要

ISO/IEC 17025:2017和ISO 15189:2012规定了对实验室能力的要求。前者是指一般的实验室，其活动包括检测、校准和抽样，然后进行检测或校准。后者是指医学实验室。尽管这两个标准之间存在差异，反映了它们各自所处理的具体需求，但这两个文件的发展到目前为止遵循了类似的路径。在本报告中，介绍了ISO/IEC 17025关于抽样的要求以及由此产生的不确定度，强调了测试实验室需要考虑的问题。此外，还与ISO 15189在采样和测量不确定度方面的要求进行了比较。在此基础上，讨论了是否可以在目前正在进行的ISO 15189修订中纳入类似于新的ISO/IEC 17025所引入的采样不确定度方法的问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Uncertainty from Sampling - Could the Requirements of ISO/IEC 17025 (2017) be adopted in Medical Laboratories?

ISO/IEC 17025:2017 and ISO 15189:2012 specify the requirements for the competence of laboratories. The former refers to laboratories in general, whose activities include testing, calibration and sampling followed by testing or calibration while the latter refers to medical laboratories. Despite the differences between the two standards reflecting the specific needs each of them is addressing, the development of these two documents has, until now, followed similar paths. In this presentation the requirements of ISO/IEC 17025 referring to sampling and the uncertainty arising from it are presented underlining what testing laboratories need to consider. In addition, a comparison with the requirements of ISO 15189 with regard to sampling and measurement uncertainty is made. Based on this, the question whether an approach on uncertainty from sampling similar to the one introduced by the new ISO/IEC 17025 can be included in the revision of ISO 15189, currently under way, is addressed.

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来源期刊

International Journal of Reliable and Quality E-Healthcare Nursing-Leadership and Management

CiteScore

3.20

自引率

0.00%

发文量