Fresenius Kabi

Quality management at Fresenius Kabi is based on the internationally recognized quality management standard ISO 9001 and a great many national and international regulations relevant for the products manufactured by Fresenius Kabi, such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) for drugs, and the quality management standard ISO 13485 for medical devices. The implementation and application of these requirements is based on quality management documents that apply throughout the company. We also regularly review compliance with our quality standards and the efficiency of the quality management system at all locations through internal audits.

We adapt our quality management system continuously to changing legal requirements. In 2010, for instance, the additional requirements of the European Medical Devices Directive came into force.

In 2010, we reviewed the quality management system’s conformity with the relevant requirements, which was successfully validated. The entire value chain at Fresenius Kabi is covered by inspections by regulatory authorities and audits by independent organizations or even customers. This involves a great many operations: production plants, compounding centers, sales organizations, and corporate functions.

The matrix certification to ISO 9001 was continued as planned in 2010: We integrated production plants, compounding centers, and sales organizations in India, Europe, and in North and South America. With the exception of locations at the companies acquired in 2008, Fresenius Kabi has almost completed the global certification process.

The necessary continuous improvement of the quality management system was realized in 2010 through optimized, supplemented, and harmonized Group-wide standards. These standards are formulated by experienced experts from all functional areas.

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