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

Abstract

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.