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首页> 外文期刊>International Journal of Reliable and Quality E-Healthcare >Uncertainty From Sampling: Could the Requirements of ISO/IEC 17025 (2017) Be Adopted in Medical Laboratories?
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Uncertainty From Sampling: Could the Requirements of ISO/IEC 17025 (2017) Be Adopted in Medical Laboratories?

机译:抽样的不确定性:ISO/IEC 17025 (2017) 的要求能否在医学实验室中采用?

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摘要

ISO/EEC 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.
机译:ISO/EEC 17025:2017 和 ISO 15189:2012 规定了实验室能力的要求。前者是指一般的实验室,其活动包括测试、校准和取样,然后进行测试或校准,而后者是指医学实验室。尽管这两个标准之间存在差异,反映了它们各自所解决的具体需求,但到目前为止,这两个文件的制定一直遵循类似的路径。在本演讲中,介绍了 ISO/IEC 17025 中关于抽样的要求及其产生的不确定性,强调了测试实验室需要考虑的事项。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。基于此,探讨了目前正在进行的ISO 15189修订版中是否可以包括类似于新ISO/IEC 17025引入的抽样不确定性方法的问题。

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