Urgent Call for Action: Bridging Gaps in Asia-Pacific Laboratories' Transition to ISO 15189:2022

ISO 15189:2022 introduces key updates to medical laboratory standards, emphasizing risk management, ethics, and technical competence. With the December 2025 deadline for ISO 15189:2012 to 15189:2022 transition nearing, a cross-sectional survey was conducted during the Asia-Pacific Federation of Clinical Biochemistry and Laboratory Medicine webinar on February 21, 2025, to assess readiness. On 303 total responses, awareness was high, with 85% familiar with the revised standard and 92% recognizing its stronger focus on risk management. Most (78%) viewed the transition as highly important, and 82% expected improvements in quality and patient care. Major barriers included financial constraints (65%), insufficient training (72%), and resistance to change (45%). Preparation efforts reported were gap analyses (68%), training programs (75%), and policy updates (70%). While optimism is strong, resource limitations and skills gaps threaten timely adoption. The findings highlight the urgent need for structured training, financial support, and expert guidance to help laboratories, particularly in resource-limited settings, meet the new requirements. Collaboration among laboratories, professional bodies, and regulatory authorities will be crucial to ensure a smooth and effective transition to ISO 15189:2022, enabling more accurate, reliable, and patient-centered diagnostics.