ISO 15189 Accreditation in the Asia–Pacific Region

Abstract Laboratory accreditation may be mandatory in some countries, and ISO 15189 is the most relevant international standard. Despite this, there are few laboratories globally that are accredited. The aim of this paper is to present information on the number of laboratories accredited in the Asia–Pacific region and to which standards. Roche Diagnostics runs a triennial laboratory Survey, Lab Insights, which collects data on accreditation. The Roche benchmarking Survey gathers feedback from clinical laboratory managers and directors on their laboratories’ operation and performance. Participants from the region access the platform using any internet browser and complete the Survey digitally. The final report is available on the same platform for participants once it is validated and finalised. In some countries where translation was required or internet connectivity was limited, Roche affiliates distributed the questionnaires in hard copy. The proportion of laboratories holding ISO 15189 accreditation increased substantially from 31.9 in 2019 to 42.3% in 2022. A quantitative decrease in laboratories in the "Planning" phase, from 31.5 to 26.7%. This suggests a successful transition from strategic intent to active implementation over the three years. The cohort of laboratories reporting "No plan" for ISO 15189 adoption decreased from 36.6 to 31.1%, indicating greater support for this standard. QMS Accreditation, particularly to ISO 15189, is increasing in the region, suggesting its importance to laboratories and governments. The Asia–Pacific region accounts for a significant share of ISO 15189-accredited laboratories worldwide. This is not surprising, given the region’s population and number of laboratories. But the growing adoption demonstrates the importance of external accreditation in the region.