Abstract: 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 151 89 :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 management , 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 adopting 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.