[Challenges and Outcomes of the Process for Achieving Certification].

Clinical laboratory tests have been indispensable for medical services in recent years, and such a situation is associated with the offering of accurate test results by clinical laboratory units. A large number of facilities wishing to achieve ISO 15189 Certification follow preparatory procedures with support from consulting companies. However, in our facility, a limited budget did not allow us to use such services. As a solution, we participated in the Future Lab Session in OSAKA (FLS), a support group for the achievement of ISO 15189 Certification, when it was organized. Aiming to extensively cover and fulfill its responsibility for all processes, including clinical interpretations of the results obtained through patient preparation, in order to continuously offer high-quality test results to clinicians, our clinical laboratory unit underwent examination for certification, and consequently realized the necessity of third-party evaluation. The provision of laboratory services, fully complying with these standards, contributes to medical safety, in addition to accuracy improvement. Although the certification and its maintenance are costly, it is sufficiently cost-effective to achieve it, when focusing on improved efficiency and the enhanced quality and safety of medical services after work standardization.