Abstract:

The article presents the concept of integrating the ISO 7101:2023 Healthcare Quality Management Standard with the Hospital Accreditation Standards of the Centre for Quality Monitoring in Healthcare (CMJ) as a new approach to quality management in Polish hospitals. The traditionally applied ISO 9001 standard has proven insufficient in the medical environment, as it fails to account for the specificity of clinical processes and patient safety requirements. ISO 7101, as the first global standard dedicated to healthcare, combines organizational management with patient-centered care and a culture of quality.

The objective of the study was to determine the integrative potential of ISO 7101 and CMJ standards and to assess the feasibility of replacing ISO 9001 within hospital quality systems. The proposed methodology included a requirement compliance analysis (gap analysis), the development of an integration matrix, and a pilot implementation in a regional hospital. Simulation results demonstrated 91% compatibility between ISO 7101 and CMJ requirements, as well as notable performance improvements: a 24% reduction in response time to adverse events, a 29% increase in continuous improvement actions, and a 15% rise in patient satisfaction.

The findings confirm that the integration of ISO 7101 with the CMJ accreditation system creates a coherent, effective, and patient-focused quality management system, enabling a transition away from the generic ISO 9001 framework toward a solution tailored to the realities of the healthcare sector.