Fresenius Medical Care

As the world’s leading provider of dialysis care and products, Fresenius Medical Care has a special commitment to maintaining the best possible quality standards for its patients and customers. To meet these demands and the numerous regulatory requirements, Fresenius Medical Care has implemented comprehensive quality management systems in its regions, which reflect both the specific local conditions and the company’s global responsibility.

These systems regulate and monitor compliance with quality and safety standards for all products and procedures, from development, production, and regulatory approval to clinical application, customer training and handling complaints. The quality management system combines internal regulations and processes with the specification of external standards – such as ISO 9001:2000 for quality management systems and ISO 13485:2003 for medical products. In Europe, for instance, a growing number of dialysis clinics are undergoing the ISO 9001:2000 certification process. In the countries of Latin America and Asia, we are also having our clinics certified to this standard, for instance in Colombia and Ecuador. Most of the production sites in Europe are also certified to ISO 9001:2000 standards. Our North America production sites in Ogden, Utah, and Walnut Creek, California, as well as our Mexican site in Reynosa are certified to ISO Standard 13485:2003 for medical products, as are the production plant in Buzen, Japan and the production facility in Jiangsu, China, which produces bloodlines.

To assess quality in dialysis care, Fresenius Medical Care uses quality parameters that are generally recognized throughout the dialysis industry. One example is the so-called Kt/V value, which shows the cleansing performance of the dialysis treatment. This is calculated by analyzing the relationship between the duration of treatment and the amount of specific toxic molecules that were removed from the blood. The number of days patients are hospitalized is also crucial for determining treatment quality, because they are particularly cost-intensive and can significantly reduce the quality of life of dialysis patients. Constantly measuring these and other parameters helps us to further improve our standards in providing dialysis treatment.

The quality management implemented at our sites and at our dialysis clinics is regularly audited. In Europe, this is handled by the TÜV. These conformance and certification experts check our corporate headquarters, the production plants as well as sales organization and clinical organizations as part of their annual audits. In the United States, Fresenius Medical Care’s production facilities are regularly audited by the U.S. Food and Drug Administration. We also monitor the effective implementation of our quality management systems through regular internal audits performed by employees who are specially qualified and trained for this purpose. Furthermore, through regular patient and customer surveys, we obtain valuable feedback, for instance, on the acceptance of our customer, delivery, and technical customer service, on our vacation and travel service, as well as on its home visits and on the general quality of the care provided.

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