As part of our QMS, we train employees at every level of our organization on the quality matters relevant to their functions. This includes all new employees and those who take on new roles within our company.
Quality management and product safety
Delivering exceptional patient care
In our Quality Management System (QMS), we define processes and assign clear responsibilities within teams and across our company.
Our QMS is certified to internationally recognized standards, such as ISO 9001. This certificate covers over 120 of our organizations, including market units, compounding centers, and production units worldwide. In the future, we aim to integrate even more Fresenius Kabi organizations.
Certified to maintain best practices
International standards, like those issued by ISO, help to ensure we:
- Adhere to recognized best practices,
- Identify potential risks early on,
- Continuously improve our processes, policies, and procedures.
We also maintain extra certifications in various areas of our quality-related operations, such as our manufacturing processes for medical devices and food safety.
Our QMS is supported by our Monitoring and Reporting System. We use it to review the effectiveness of our suppliers’ processes, policies, and procedures – and identify where they can be improved.
We also use a special metric to enhance our quality monitoring efforts: the Audit & Inspection Score.
The score indicates the average number of major observations and non-conformities found in our inspections and audits.
Audit & Inspection Score:
1.7 in 2024 (1.9 in 2023)
Our target value: 2.3 or better – based on past results of our sites’ third-party inspections and audits
To incentivize a robust Monitoring and Reporting System, the Fresenius Group has integrated the Audit & Inspection Score into the short-term variable compensation of our Management Board.
For more information on our quality monitoring and reporting metrics, see the corresponding section of the Fresenius Annual Report.
Internal audits: 33 in 2024 (58 in 2023)
External audits and inspections: 92 in 2024 (111 in 2023)
Revolutionizing Cleanroom Training
Discover how Fresenius Kabi is transforming cleanroom workforce preparation with immersive Virtual Reality (VR) training simulations. Learn about enhanced learning efficiency, real-world applications, and the future potential of VR technology in aseptic manufacturing.
Recording side effects
Collecting and assessing any information about risks that may be associated with our products.
Goal: identify product-related risks at an early stage and take appropriate corrective or preventive actions.
Evaluating side effects
Company-wide standard operating procedures (SOPs) used to monitor and assess the benefit-risk profiles of our products.
Goal: maintain reliable information on the safe use of our products.
Notifying the authorities
Submitting the results of continuous evaluations of safety-relevant information to health authorities.
Goal: compliance with regulatory requirements and transparent safety reporting.
Informing stakeholders
Promptly informing healthcare professionals about relevant changes to the safety profile of our products.
Goal: transparent communication to contribute to safe usage of our products.
Since 2020, our initiative “Quality starts with me” has strengthened the quality culture across all our global production facilities. Led by the Head of Global Quality Management, this initiative features regular surveys and local campaigns to drive continuous improvement in product safety and healthcare. Quarterly status reports from quality assurance managers keep us informed about local efforts, ensuring a strong and consistent quality management at every site.
Labeling and product information
Accurate labeling and clear product information help patients and healthcare professionals make informed decisions. By adhering to stringent regulations and keeping our information up-to-date, we aim to ensure our products – from pharmaceuticals and nutritional products to medical devices – meet high safety and efficacy standards and protect the health and well-being of those who rely on them.
Our approach to labeling and product information is based on the following steps:
Product Classification Standards
Our products are classified based on global and national regulations.
Maintaining Compliance
We have global policies and procedures to ensure our product information is clear, accurate, not misleading, and adheres to all applicable laws and regulations.
Labeling Requirements
Our products undergo regular label reviews and updates as part of our regulatory activities. When authorities like the European Medicines Agency (EMA) publish new information, we promptly update our labels.
Managing Product Labeling
For accuracy, we use an electronic system to manage our product labeling and packaging information. We comply with the European Falsified Medicines Directive and the U.S. Drug Supply Chain Security Act, implementing processes for serialization, testing, and traceability.
Would you like to find out more about quality management at Fresenius Kabi?
Meet Beata, our Project Manager Global Quality, who shares her experience of working on our strategic framework.
Disclaimer
Fresenius Kabi is a fully consolidated subsidiary of Fresenius SE. This website includes an overview of the Fresenius Kabi sustainability commitment. All data on this website corresponds to a subset of group data that is published in the Fresenius Group Sustainability Statement 2024 and thus is assured by an external auditor. The Sustainability Statement is prepared in full compliance with the European Sustainability Reporting Standards (ESRS).