Developed in Japan in the 1950s, Total Quality Management/Continuous Quality Improvement (TQM/CQI) approaches have been taken up in a variety of forms by many healthcare organisations since the early 1990s. Although TQM/CQI has several strengths, including a strong customer focus and the use of data to analyse variations in quality, its use in health care has encountered a range of practical and cultural obstacles. In the first of five articles looking at major approaches to quality improvement that have been used in healthcare organisations in the past two decades, the authors review the potential of TQM/CQI and the challenges of using this approach to improve patient care.