Certification of a urodynamics laboratory: Analysis of a multi-centre certification project

The search for "Quality" in industrial production and the provision of services can be traced back to the industrial revolution. Until the thirties the main concept was the systematic control of products coming out of the factories. In the fifties, Quality was also extended to design and the concept of co-ordination between different company functions was introduced. The ISO 9000 standards were set up in the seventies as an operating tool for application and control of a "Quality System". These standards, worked out by the ISO (International Standardising Organisation), were translated in Europe by the European Committee of Standardisation (CEN) and assimilated in Italy by the Ente Nazionale Italiano di Unificazione (UNI). Their application began in the eighties in the Services sphere and more recently in the Health sphere. They are voluntary standards, the application of which is controlled by bodies called "Certification Bodies". Their aim is to achieve: 1) client satisfaction; 2) operator satisfaction; 3) corporate satisfaction. ©2001, Editrice Kurtis.