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Implementing an ISO 9001-based Quality Management System in a Clinical Simulation Centre: Integration of Training Delivery, Governance, and Research - PubMed

3 hours ago
  • #Clinical Simulation
  • #Quality Management
  • #ISO 9001
  • Implementation of an ISO 9001-based Quality Management System (QMS) in a clinical simulation center to integrate training, governance, and research.
  • A descriptive case study using mixed methods (statistics and thematic analysis) to assess QMS performance, structured around core processes including training delivery, governance, and research.
  • QMS implementation led to reduced incidents (54% decrease), increased survey participation (>99%), and improved traceability, alongside strengthened governance and SSH accreditation alignment.
  • The integrated model enhances standardization, risk management, continuous improvement, and scalability within healthcare organizations.
  • Conclusion: ISO 9001 aligned with SSH standards provides a robust, transferable framework for quality and accreditation in simulation-based education.