We produce and deliver a broad range of products for treating kidney disease. With our network of 44 manufacturing sites in more than 20 countries, we take care of the procurement, production, distribution, and supply of renal and multi-organ therapy products. We manage the quality and safety of our product business over the entire product life cycle, from design and development to operation and application.
Two global functions are responsible for our product business: Global Research and Development and Global Manufacturing, Quality and Supply. Both functions report directly to the Management Board. They have jointly developed our Global Quality Policy, which describes our commitment to product and service quality. It also covers our obligation to comply with relevant regulations and maintain environmentally sound and efficient operations. The Management Board is regularly informed about our global quality performance.
Our operations are subject to extensive governmental regulation in virtually every country in which we operate. To fulfill our commitment to product quality and safety while complying with the numerous relevant regulatory requirements, our processes are embedded in comprehensive quality management systems. As a result, all our products need to comply with safety and quality standards. This covers their development to market approval, manufacturing, use in clinics, customer training, and dealing with complaints. To produce safe products with a reliable quality, our plants are subjected to regular external quality audits and reviews in accordance with local requirements. In addition to audits carried out by notified bodies and authorities, including the U.S. Food and Drug Administration (FDA), the German Ministry of Health and other applicable national health authorities, our local sites are subject to management reviews and regular internal quality audits. Any cases of non-conformance detected as part of these quality audits are forwarded to the respective department to determine and implement appropriate corrective and preventive measures.