ABSTRACT
This book has been written around the quality management principles of the ISO 9001:2000 ‘process’ management model. The implementation of a quality management system using the process management approach espoused by the ISO 9001:2000 standard is reflective of the need for quality management in assisted reproductive technology (ART) today. The concepts defined in this book express that all clinical inputs and expected out-comes are the result of a process. In the case of a quality management system, the driving forces typically derived from the quality management system are patient/customer needs and expectations, satisfaction and continual improvement within the practice. ISO 9001:2000 suits the ART environment well because of the focus it places on the patient/customer and the emphasis it places on the IVF practice’s management systems, processes, protocols and instructions. This is especially true in that an ISO 9001:2000 quality management system provides the framework and methodology for monitoring and measuring conformity to requirements, enhancing patient/customer satisfaction and continually improving the quality of service delivery. Service delivery for the IVF practice is not solely about clinical outcomes but should be the focus of every aspect of the service delivery continuum within the practice. Implementing and
maintaining a sustainable quality management system becomes the way that the practice operates, always keeping its focus on the patient/customer. The ISO 9001:2000 standard is based on eight quality management principles. These principles become the ‘factors to success’ for any IVF practice. These principles are customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decision-making, and mutually beneficial supplier relationships.
