Implementation of a quality management system in a liver transplant programme

Area of Science:

• Healthcare Management
• Transplantation Medicine
• Quality Assurance

Background:

• Liver transplantation management is complex, requiring teamwork and best practices for success.
• ISO 9001:2015 provides a framework for implementing a Quality Management System (QMS).
• A QMS ensures high standards of clinical quality and patient safety in transplantation programs.

Purpose of the Study:

• To outline the implementation process of a QMS in a liver transplant program (LTP).
• To identify the strengths and limitations encountered during QMS implementation.
• To achieve ISO 9001 quality certification for the LTP.

Main Methods:

• Analysis of the starting point and formation of a working group.
• Training, defining certification scope, and documentation preparation.
• Conducting internal and external audits leading to ISO 9001 certification.

Main Results:

• The QMS implementation generated comprehensive documentation for transplant activities.
• Established indicators enabled process effectiveness measurement and risk management.
• Achieved ISO 9001 quality certification for the liver transplant program.

Conclusions:

• ISO 9001:2015 certification fostered a patient-centered quality and safety culture.
• Protocolization, measurement, and verification reduced variability in clinical practice.
• Continuous improvement and better understanding of work dynamics were achieved.