Quality management systems in ART: are they really needed? An Australian clinic's experience.

As assisted reproductive technology (ART) expanded globally, several countries introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement. While it is common for ART laboratories to be required to have an effective quality control system, the remainder of the clinic is often under less stringent regulation. Furthermore, when treatment conditions are prescribed, the standards tend to be conservative and clinics may choose to establish their own standards. Total quality management systems are now being used by an increasing number of ART clinics. In Australia and New Zealand, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services in these two countries.