Objective: The medical laboratory quality assessment criteria issued under Decision 2429/2017/QD-BYT are organized into 12 quality system essentials comprising 169 criteria, whereas ISO 15189:2022 arranges its requirements along the Plan–Do–Check–Act (PDCA) continual improvement cycle. This study aimed to establish, operate, and evaluate a quality management system harmonizing the two structures in a hospital laboratory.
Methods: A descriptive interventional study was conducted at the Laboratory Department of Hong Bang International University Hospital from January to December 2025. The chapters of Decision 2429/2017/QD-BYT were mapped to the clauses of ISO 15189:2022, re-ordered along the PDCA cycle, and translated into a coherent documentation chain comprising the quality manual, procedures, and records. The system was implemented and assessed using the Ministry of Health quality-level checklist.
Results: A correlation matrix linking the 12 chapters to Clauses 4 to 8 of ISO 15189:2022 was produced, and the 12 essentials were restructured into four PDCA phases. The documentation comprised 3 manuals, 39 PDCA-coded management procedures, and a 6S-based records system. After one operating cycle, the self-assessment score reached 234/268 points over 169 criteria, rising from 67.4% (level 2) to 87.3% (level 3).
Conclusion: Harmonizing the 12-essential structure with the PDCA model enables a laboratory to satisfy national requirements and international orientation through a single, workable documentation system, and may serve as a transferable model for other medical laboratories.