Comparison analysis of nonconformities and strategy of change version for ISO 15189:2012 and ISO 15189:2022
Objective To analyze nonconformities between 2012 and 2022 version of ISO 15189,and provide strategies of transitioning to new standard for laboratories.Methods A total of 522 nonconformities from 32 on-site audits in 24 laboratories against ISO 15189:2012 were collected and mapped them to the relevant clauses of ISO 15189:2022.Strategies for transitioning ISO 15189 to new version were explored based on the standard requirements,literature review and current laboratory practices.Results On average,16 noncon-formities(range from 8 to 31)were identified in every on-site audit.Most of them were related to ISO 15189:2022 clauses 7.3 Exami-nation Processes(165 nonconformities).The others were clause 6.5 Equipment Calibration and Metrological Traceability(43)and clause 6.6 Reagents and Consumables(40).Relatively fewer nonconformities involved new/enhanced requirements,such as risk man-agement,patient-related processes and point-of-care testing.Conclusion The main nonconformities in ISO 15189:2022 predominantly involved in the link of examination processes.It should be suggested that the laboratories strengthen the management in this area by a-dopting digital/intelligent technologies in order to smoothly implement the requirements of the new version of ISO 15189:2022 standard.A comprehensive strategy,including incorporating training,gap analysis,document revision,implementation involved in all staff,stringent risk management and continuous improvement should be recommended to ensure successful transition progress for replacement of ISO 15189:2022.
medical laboratoryaccreditationnonconformityrisk managementISO 15189:2022
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