ABSTRACT
Quality management (QM) systems have become integral management tools in many in vitro fertilization (IVF) centers around the world. The European Union Tissue Directive, issued in 2004, clearly demands a QM system for any institution handling human gametes/embryos. The primary concerns of any healthcare system will continue to be clinical outcomes. However, if we regard medical facilities as businesses providing a particular service to patients and referring doctors, then other parameters beyond clinical outcomes become important. Governmental agencies and insurance companies will continue to place increasing pressure on documenting that they provide services in a particular fashion. This will mean that strict procedures for documentation of results will be needed and, furthermore, practices could be penalized if not performing adequately. Governmental agencies control some practices through regulations (e.g., certain infection disease protocols). However, beyond these rules, many medical organizations currently develop their own internal standards. These standards are often only informally documented and most of the time are fragmentary. These standards affect and direct the internal workings of the organization and the interactions of various areas within the company. They may also affect the interactions of the company with external partners. For example, if every institution were to use their own internally developed methodology for documenting and handling different procedures, then it would be very difficult to compare and contrast different systems. A customizable single system to follow all the internal workings of the organization is the goal of the QM systems such as that of the International Organization for Standardization (ISO; see below). A very important element to recognize is that an organization has many “customers.” Often clinicians feel uncomfortable referring to our patients as customers, but of course patients are our key customers. But other “customers” exist and include referring doctors, insurance companies, regulatory bodies, and students, among others. Another set of key customers consist of our employees—our “internal customers.”
