QUALITY MANAGEMENT

Our ISO 9001:2000-based quality management has the following three objectives:

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.

To assess quality in dialysis care, we use the generally accepted quality parameters customary in dialysis, such as the hemoglobin values. Hemoglobin mainly serves to transport oxygen from the respiratory organs to the body tissues that use oxygen. Our patients should have a hemoglobin level of at least 11 grams per deciliter of blood. The average hemoglobin level for healthy people is slightly above that. Other indicators we use to assess treatment quality include the phosphate level and the so-called Kt/V value, which measures the effectiveness of the dialysis treatment by calculating the filtration rates for certain toxic molecules in relation to the length of treatment. Other quality indicators are albumin, which gives an idea of the patient’s general nutritional condition, and the number of days which dialysis patients have to spend in the hospital. Measured on the basis of the above parameters, the quality of dialysis treatment at Fresenius Medical Care was further improved in 2007.

Fresenius Kabi

Quality management at Fresenius Kabi is subject to a great many national and international regulations such as Good Manufacturing Practice (GMP) and ISO Standard 13485:2003 as well as regulatory, product-specific requirements. All of these considerations have been integrated into a quality management system conforming to ISO Standard 9001:2000. Quality management at our production sites, in the sales organization, and at a cross-functional level is reviewed regularly by national and international regulatory authorities and by customers. The high standards and functionality of the systems were again confirmed.

Various harmonization projects, such as the harmonization of analytical methods and the regulatory approval documentation, were continued in 2007. International working groups pursued these projects with the aim of obtaining regulatory approvals faster and speeding up the relocation of the production of individual products, for example after an acquisition.

Filaxis, based in Buenos Aires, Argentina, which was acquired as of April 30, 2007, was integrated successively into the quality management system and due for completion at the beginning of 2008. With this acquisition, we have widened our manufacturing expertise to include generic chemotherapy drugs. Since chemotherapy drugs have to be handled with great care, employee protection will therefore play a greater role in our quality management system within this product group.

In addition, a pre-approval inspection of our production facility in Halden, Norway, by the US Food and Drug Administration (FDA) for an additional product was successfully completed. The FDA inspects whether the production plant and processes for a single product conforms with US regulations. Following the pre-approval inspection and after having received drug approval it is allowed to export the respective drug to the United States. The plant in Graz, Austria, which as the center of competence for aseptic manufacturing processes specializes in the production of parenteral nutrition and intravenously administered drugs, is FDA approved. The plant’s GMP standard is of the highest international level as demanded for instance by U.S., E.U. and WHO GMP. The plant is ISO 9001:2000 and ISO 13485:2003 certified.

The roll-out of ISO-9001 certification to further Fresenius Kabi locations was continued. After all the European production and sales sites were integrated in the external certification to ISO 9001:2000 in 2006, the focus in 2007 was on the production facilities outside Europe.

Fresenius Helios

The unique quality management system at Fresenius Helios that was developed in-house is devoted to a continuous improvement in patient care. About 700 indicators cover all the main diseases so that the number of treatments, e.g. surgeries, performed and, where possible the quality of the outcomes, can be recorded. On the basis of over 142 indicators, the 30 most important diseases and surgeries are regularly published externally for the HELIOS Group in its own annual medical report and for the individual clinics in the respective hospital guidebooks. These publications assure an exemplary transparency of HELIOS’ performance externally. Demanding group targets were defined for 33 indicators.

In these areas HELIOS Kliniken aims to be at least as good as the German average. Where benchmark data are available, HELIOS expects the clinics to match best-in-class international standards in surgical medicine. The Group met or significantly exceeded the targets for 25 of these indicators (clinics as of December 1, 2007). Mortality rates in the case of major diseases such as heart attack, heart failure, stroke, and pneumonia, and of many major surgeries Group-wide were well below the German average, by as much as 23% in some cases. For instance, in the treatment of fractures of the neck of the femur, often caused by falls in elderly persons, the mortality rate was 5% below the German average. Where the targets were not achieved, the deviation from the German average was so small that it is statistically not significant. The medical teams at HELIOS are also pursuing additional goals relating to care in the various specialist areas.

Fresenius Vamed

In the planning and construction of hospitals, Fresenius Vamed sets high quality standards in the flexible design of parameters across processes and structures. These parameters include process optimization (covering, for example, ambulance centers, admission and discharge centers, interdisciplinary emergency centers, interdisciplinary outpatient clinics), differentiation according to modular care levels (from basic to intensive care), and the flexible use of buildings and wards in response to shifts in demand – always allowing for the given reimbursement systems and technological developments. VAMED has an internationally experienced team of experts who assure the quality of the structural and process design even when a project is at the concept stage and then when services are performed. Internally, the processes are designed for efficiency and sustainability on the basis of interdisciplinary quality standards. These standards are mostly based on ISO Standards 9001:2000 and ISO 13485:2003, as well as the standards of the European Foundation for Quality Management (EFQM).