Management Report Non-Financial Performance Indicators and other Success Factors Quality Management 
QUALITY MANAGEMENT
Our ISO 9001:2000-based quality management has the following three objectives:
- to identify value-enhancing processes oriented to the needs of our customers and to efficiency,
- to monitor and steer these processes on the basis of performance indicators, and
- to improve procedures.
These objectives cover the quality of our products and all services and therapies that we provide. Our quality management system integrates all product groups, such as drugs, medical devices, and nutrition, as well as our clinics. The methodology is regularly evaluated through internal audits and external certification bodies.
Our products are already closely controlled at the development stage. Our drugs are subject to regulatory approval, so appropriate documentation has to be prepared and submitted in accordance with national and international regulations. Medical devices undergo a conformity assessment procedure that documents compliance with the appropriate norms. In enteral nutrition, we already follow the Hazard Analysis Critical Control Point (HACCP) principle during the development process.
We have established quality assurance systems in all our production facilities. In addition to the controlled use of materials, validated production procedures as well as ambience and in-process controls, each batch produced also undergoes final controls and a formal release procedure. Our production facilities are regularly inspected by regulatory authorities or other independent institutions. All audits and inspections led to the renewal of the relevant manufacturing authorization or certification.
Sales and marketing are also an integral part of the quality management system. For example, at any given time we are able to trace which batch was supplied to which customer. In recent years, Fresenius Helios has initiated and further developed a performance indicator system to evaluate the quality of medical results in hospitals. The system is acknowledged as a highly innovative procedure within the hospital market, although it is not based on ISO certification. The system is also used as quality standard in more than 200 German hospitals outside HELIOS Group. Furthermore, in 2008 the Swiss Federal Office of Public Health (Bundesamt für Gesundheit) started a pilot project for the survey and publication of quality indicators in the hospital market, based on the HELIOS quality management system.
Fresenius Medical Care
Fresenius Medical Care’s Integrated Management System (IMS) takes account not only of ISO Standard 9001:2000 but also the special standard for medical products ISO 13485:2003. IMS was already introduced at all production facilities in Europe in 2006. The production sites in the United States and in Mexico are also certified to ISO 13485:2003. In 2007, IMS was introduced at another approximately 40 dialysis clinics. Over 70% of the Fresenius Medical Care clinics in Europe are now certified, compared to about 65% in 2006. To proceed the large number of audits in future, about 20 additional employees underwent quality management training in 2007, qualifying them to carry out audits in accordance with IMS standards (2006: 50 employees). In each of the countries, Fresenius Medical Care paid special attention to integrating senior nursing staff into the audit process that also checks hygiene standards at our dialysis clinics. The concept of involving experts in the audit process was therefore systematically continued.
