Quality Management

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The quality and safety of our products and services are the basis of our business activities. Therefore, we strive for harmonized standards and processes worldwide to safeguard the highest quality.

What Quality means to Fresenius Kabi

This commitment implicates the application of a quality management that assures the quality of products in terms of safety and efficacy. At Fresenius Kabi, quality is an integral part of our day-to-day operations, of our business strategy and business philosophy.

Our quality management system is designed to ensure compliance with all applicable national and international requirements as well as to meet the expectations of our partners and customers. For us, it is an ongoing task to undertake regular quality improvements across all operations with the aim to support medical professionals in the best possible therapy and care for critically and chronically ill patients around the globe.

The basis for our lasting and successful partnership with our customers is the commitment to consistently high and ever improving quality of ​our products and services. Therefore, our quality management system according to the international ISO 9001 standard is regularly reviewed during internal quality audits and certified by external auditors. Currently Fresenius Kabi has an ISO 9001 certificate covering around 110 of our organizations, comprising Market Units, Compounding Centers and Production Units around the globe. We continuously expand the successive integration of all the Fresenius Kabi organizations into our ISO 9001 matrix certification.

Quality Policy Fresenius Kabi

Our products and our services, as well as the commitment and dedication of our employees, are focused on the critically and chronically ill patient inside and outside the hospital.

It is our responsibility that these products meet all applicable quality and safety standards.

In order to fulfill this fundamental prerequisite, the company maintains a quality management system which assures the quality of products with regard to safety and efficacy.

This system guarantees compliance with national and international legal requirements and meets the expectations of our partners and customers.

The quality management system is based on the following principles:

  • clear assignment of responsibilities
  • educated and well-trained employees
  • ​continuous safety monitoring
  • ​transparent and documented procedures
  • controlled production processes​
  • continuous improvement​​​​​​​​​

We are striving for worldwide harmonized standards and processes to implement highest quality profiles wherever we manufacture.

NABP Accredited

Fresenius Kabi, LLC distribution facilities have been awarded NABP Accreditation.
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