Implementation of a quality management system in a liver transplant programme

BACKGROUND: The management of liver transplantation has become a complex process involving different healthcare professionals. Teamwork, standardisation and definition of the best practices are essential for success, patient satisfaction and society’s favourable perception of transplantation programmes. ISO 9001:2015 certification provides the necessary elements to help implement a quality management system (QMS) to ensure that patient care is performed with the highest guarantees of clinical quality and safety. The aim of this study is to describe the steps, strengths and limitations in the implementation of a QMS in a liver transplant programme (LTP). PROJECT MANAGEMENT METHOD: This included analysing the starting point, setting up a working group, training, defining the scope of certification, preparing documentation, and conducting an internal and external audit, which culminated in the ISO 9001 quality certification award. The scope of QMS includes all the processes of LTP, from referral of candidates to long-term follow-up after transplantation. RESULTS: The project was structured in seven phases that took place between 2008 and 2011. The implementation of QMS led to the generation of all the necessary documentation to meet the requirements of the standard, including internal and legal requirements related to the transplant activity. The establishment of indicators to measure the effectiveness of processes, risk management and the identification of incidents allows us to implement measures devoted to avoiding the deficiencies and to meet the established objectives. CONCLUSION: ISO 9001:2015 certification has contributed to the adaptation of a new quality and safety culture focused on the patient. All activities are protocolised, everything is recorded, measured, and verified, and all steps are taken as planned. Work is carried out in terms of continuous improvement. This has led to less variability in daily clinical practice and a better understanding of work dynamics.