Comparison of ISO 15189: 2022 and ISO/IEC 17025: 2017 for quality system development of laboratory
Keywords:
ISO 15189:2022, ISO/IEC 17025:2017, Accreditation, Quality management systemAbstract
Quality is the degree to which characteristics of something, such as products, services or processes that meet customer needs through the assessment and accreditation according to international standards. ISO 15189:2022 specifies the requirements for quality and competence in medical laboratories , while ISO/IEC 17025 provides the requirements for the competence, impartiality and consistent operation of testing and calibration laboratories. Therefore, in order to provide laboratories with information to use as guidelines for their effective application, a study was conducted to compare the requirements between both standards. It was found that the structural requirements of ISO 15189:2022 is aligned with the ones from ISO/IEC 17025:2017 covering five main points: (1) general, (2) structure, (3) resources, (4) process, and (5) management system which laboratory activities shall be undertaken impartially. Identifying risks and choosing opportunities are still the driving forces to improve the effectiveness of the quality management system. Additionally, The scope of activities vary depending on the laboratory context, for example pre-examination process and laboratory for point of care testing so that all the processes in ISO 15189:2022 have to consider potential risk to the patient . As for ISO/IEC 17025:2017 , sampling process, the decision rule when reporting a statements of conformity and information of metrological traceability in Annex A are included. Comparing the requirements between ISO 15189:2022 and ISO/IEC 17025:2017 will encourage laboratories to improve their service quality and tailor its single, unitary quality management system throughout the entire organization leading to improvement of the National Quality Infrastructure and Thailand’s competitive.
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