Background: The International Organization for Standardization (ISO) 15189 standard is essential for quality management in clinical laboratories, yet its integration into undergraduate medical laboratory technology education remains limited. This study aimed to evaluate the impact of a simulated laboratory teaching model based on the ISO 15189 standard on the quality management competencies of undergraduate interns and to compare it with traditional teaching methods. Methods: A parallel-group, randomized controlled trial was conducted in the Department of Clinical Laboratory at the Second People’s Hospital of Hunan Province (Brain Hospital of Hunan Province). A total of 60 undergraduate medical laboratory technology students scheduled to commence their clinical clerkship between July 2023 and May 2025 were enrolled and randomly allocated to an intervention group (n = 30) or a control group (n = 30). The intervention group received simulated laboratory teaching based on the ISO 15189 standard, including the construction of a quality management system and full-process simulated accreditation practice. The control group received traditional clinical clerkship teaching. Primary outcome measures were comprehensive assessment scores at the end of the internship (covering pre-examination, intra-examination, and post-examination quality control knowledge) and problem-solving ability scores in quality management roles. Secondary outcome measures included understanding of the quality management system, quality improvement awareness, and teaching satisfaction. Results: Compared with the control group, the intervention group showed significantly higher scores in pre-examination quality control, intra-examination quality control, post-examination quality control, understanding of the quality management system, quality improvement awareness, and problem-solving ability in quality management roles ( P < .01). Teaching feedback questionnaires also indicated higher satisfaction with the teaching model in the intervention group. Conclusion: For undergraduate medical laboratory technology interns, the simulated laboratory teaching model based on the ISO 15189 standard is significantly more effective than traditional teaching methods in enhancing their knowledge, skills, and competency in quality management.
Ma et al. (2026) studied this question.