Development of a quality document management system for ISO 15189 compliance in a clinical laboratory using Microsoft 365: A digital transformation approach to ISO 15189

Abstract

Document management is a cornerstone of a quality management system (QMS) under ISO 15189, yet its implementation often requires expensive, dedicated software. With the upcoming release of JIS Q 15189 in late 2025, many laboratories in Japan face the challenge of establishing an efficient and affordable document control system. This paper reports the development and implementation of “DMS for Gifu,” a QMS document management system built to comply with ISO 15189:2022 standards using only the standard features of Microsoft 365 (M365). The system was developed with a no-code approach, primarily by biomedical scientists (medical technologists). It integrates Microsoft SharePoint, Lists, Teams, and Power Automate to automate document approval workflows, version control, and staff notification and training records. Implementation of DMS for Gifu led to a reduction in the time required for information dissemination. Furthermore, it achieved a decrease in overtime hours for key quality management staff. This study demonstrated that a general-purpose business platform like M365 can effectively serve as a robust foundation for a QMS in a clinical laboratory. This user-led digital transformation provides a low-cost, sustainable, and effective alternative to specialized systems, offering a practical solution for laboratories seeking ISO 15189 accreditation.