Adapting ISO 17025 to Enrich QoS as Quality Measurement on Internet of Medical Things

Abstract

Biomedical tool quality assurance needs to be concerned regarding its measurement validation worrying its function to treat the human body. It has been found that in reported medical tools on the internet of medical things (IoMT), the quality of the tool is defined mostly only using Quality of Service (QoS). It has not been standard yet that medical tools also must be concerned about their quality measurement. This article imposed to elaborate on developing quality assessment in the medical tool by adapting ISO 17025 as quality measurement, particularly the validation method. ISO 17025 is the method using notable parameters used in the quality of laboratory of measurement. The parameters include calibration, selectivity, sensitivity, precision (repeatability), accuracy, linearity and working range, robustness, and ruggedness (reproducibility). To clarify how this standard is implemented, the medical tool, detector of kidney disorder based on pH meter using urea and acid solution, is employed as a case study. The result said that even though QoS is a very good outcome, this biomedical tool has crucial parameters particularly in calibration. Hopefully, this article could be a reference to enhance the quality standard of medical tools.