Implementing an ISO 9001-based quality management system in a clinical simulation center: integration of training...

Clinical simulation centers have evolved into complex organizational units delivering high-impact educational services within healthcare systems. However, evidence on structured quality management systems (QMS) governing simulation-based education remains limited. International standards such as ISO 9001 and professional accreditation frameworks such as the Society for Simulation in Healthcare (SSH) provide complementary approaches to ensure quality, safety, and continuous improvement.

We conducted a descriptive organizational case study of the implementation of an ISO 9001-based QMS in a hospital-integrated advanced clinical simulation center. Data sources included audit reports, key performance indicators (KPIs), incident logs, and satisfaction surveys. A mixed-methods approach combining descriptive statistics and thematic analysis was used to assess system performance and maturity. The QMS was structured around three core processes: (i) management and delivery of simulation-based training activities, (ii) governance, including stakeholder engagement, risk assessment, performance monitoring through key performance indicators (KPIs), and continuous improvement actions, and (iii) research and innovation activities. The system was aligned with the CORE and Training accreditation standards of SSH.

The implementation of the QMS enabled standardization of training processes, traceability of educational activities, systematic risk management, and performance monitoring across all simulation programs. Incident rates decreased from 125 to 57 cases (-54%), survey participation increased from 56.8% to >99%, and traceability of participants more than tripled. Governance structures were strengthened through formalized decision-making bodies, stakeholder involvement, and periodic management reviews. Alignment with SSH accreditation reinforced educational quality, faculty development, and learner-centered design. The integrated model facilitated sustainability, transparency, and scalability of simulation activities within a large public healthcare institution.

An ISO 9001 based QMS, aligned with SSH CORE and Training standards, provides a robust framework for integrating simulation-based education, governance, and research within healthcare organizations. This model supports continuous improvement, enhances accountability, and may serve as a transferable reference for other simulation centers seeking formal quality and accreditation pathways.