To explore a risk management framework based on ISO 15189 and biosafety to enhance risk management capabilities in biochemical testing.

According to CLSI QMS03 requirements, a risk management practice framework was constructed, including standardized online theoretical training, nonconformity management practices based on ISO 15189 and WS/T 442, and digital intelligence-based practices following the ISO 22367 risk management process. In 2025, 42 trainees were enrolled to validate the training effectiveness of this framework by assessing their mastery level (5-point scale) and theoretical assessment results (100-point scale), while evaluating risk management practices and risk priority numbers (RPN) in biochemical testing.

Trainees achieved a mastery level of 4.50±0.27 for risk management practices, and theoretical assessment scores significantly increased from 61±15 to 91±11 after training (P＜0.001). Established A general laboratory risk source database containing 122 items was established and 30 potential risk points specific to biochemical testing were identified, including 27 low-risk, 2 medium-risk, and 1 high-risk point. For the three medium- and high- risk points, quality control monitoring throughout the process (RPN 48), handling of infectious specimens (RPN 24), and delayed critical value reporting (RPN 24), corresponding risk control measures were implemented, reducing the risks to acceptable levels, and these were incorporated into the risk monitoring list.

An effective risk management framework has been established, integrating theoretical learning, contextualized practice, and risk assessment tools, thereby enhancing risk management capabilities and practical proficiency.