Quality management and product safety

Delivering exceptional patient care

Quality management and product safety are integral to how we support patient care. Our approach includes quality management systems, product safety and risk management, employee training, audits and inspections, regulatory compliance, and product information management. In this section, you can learn more about our quality-related processes, targets, and reported performance.

Quality management and product safety are central to how we support patient care. Our focus is on developing, manufacturing, and supplying products in line with applicable regulatory, safety, and quality requirements, so that healthcare professionals can rely on them in their daily work. 

Our commitment to quality management and product safety is a collaborative effort, where our employees and suppliers play an essential role in delivering quality excellence to our patients and customers. From adhering to standards and procedures to providing valuable feedback, their unique insights help us improve patient safety and well-being. 

We report in detail on our targets, the measures planned to achieve them, and current progress in our Annual Report 2025. 

woman in hospital
Vials at production unit Graz, Austria

Quality management at Fresenius Kabi

Our quality management is built on three pillars: our ISO-certified Quality Management System (QMS), our Monitoring and Reporting System, and an in-depth training program for employees. These preventative measures and actions form the basis for structured quality processes across the organization.

Our Quality Management System (QMS) provides the foundation for how we manage quality across Fresenius Kabi. It defines processes and assigns clear responsibilities within teams and across our company.

While regulations require us to maintain a quality management system, they do not prescribe a specific framework. To establish a consistent and internationally recognized approach, Fresenius Kabi has chosen to align its QMS with ISO 9001 and obtain certification. Today, this certification covers more than 120 Fresenius Kabi organizations worldwide, including market units, compounding centers, and production units. We aim to expand certification to additional organizations in the future.

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 hold additional certifications in various aspects of our quality-related operations, including manufacturing processes for medical devices and food safety.

Further information and certification documents are available in our Resource Center

Our QMS is supported by our Monitoring and Reporting System. We use this system to review the effectiveness of our processes, policies, and procedures, and to identify areas for improvement. 

We also use a special metric to enhance our quality monitoring efforts: the Audit & Inspection Score. Fresenius Kabi has set itself the goal of continuously achieving an Audit & Inspection Score of 2.3 or better. The score indicates the average number of major nonconformities identified in the inspections and audits considered within a reporting year. More information on the Audit & Inspection Score and how it is calculated can be found in our Sustainability Statement.

To promote a robust Monitoring and Reporting System, the Fresenius Group has incorporated the Audit & Inspection Score into the short-term variable compensation for our Management Board.

For additional details on our quality monitoring and reporting metrics, please refer to the relevant section of the Fresenius Annual Report.

Discover detailed insights in the Fresenius Annual Report 2025

As part of our QMS, we provide employees with training on quality matters relevant to their roles. This includes all new employees as well as those who take on new positions within our company. These training activities support our quality standards and regulatory requirements and help employees perform their responsibilities effectively.

Cleanroom Training using Virtual Reality 

To support employee learning, some sites use Virtual Reality (VR) training simulations to prepare employees for work in cleanroom environments. While training is a requirement, the use of VR technology is one example of how we deliver training and build practical skills in aseptic manufacturing settings.

Discover how we use immersive VR simulations for cleanroom training and explore their potential applications in workforce preparation and learning.

VR Simulations Cleanroom Training
Learn more

Our commitment to product safety

Maintaining high product quality is essential for patient safety and effective treatment. That is why our safety system is designed to reliably detect, assess, and manage all potential risks. It also ensures compliance with product labeling requirements to help patients and healthcare professionals make informed decisions. These elements are vital to our QMS and demonstrate our commitment to upholding reliable product safety and efficacy standards.

Product safety system and risk management

As required by applicable regulations, we operate systems and processes to monitor and manage product-related risks. Through our global network of specialists and experts, we record and assess all complaints and side effects. This system enables us to take corrective and preventive actions quickly and efficiently. In addition, health authorities worldwide monitor and verify that our safety system complies with relevant standards and guidelines.

Woman inspecting quality of Flex Bags

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.

"Quality starts with me"

Since 2020, our initiative “Quality starts with me” has been implemented across 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. 

Labeling and product information

We comply with legal labelling requirements. Accurate labeling and clear product information help patients and healthcare professionals to make informed decisions. We adhere to the applicable regulatory requirements and keep our product information up to date. Our goal is to ensure that our products – from pharmaceuticals and nutritional products to medical devices – consistently meet the the applicable safety and efficacy standards.

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 Labeling Compliance

Our global policies and procedures as well as our regular label reviews help us to effectively monitor regulatory developments to ensure compliance with all applicable laws and regulations.

Managing Product Labeling

Our electronic systems helps us manage product labeling and packaging information, ensuring compliance with the European Falsified Medicines Directive and the U.S. Drug Supply Chain Security Act by managing processes for serialization, testing, and traceability required under the regulations. 

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.

A Cup of Earl Grey with Beata

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 2025 and thus is assured by an external auditor. The Sustainability Statement is prepared in full compliance with applicable legal requirements, incl. the European Sustainability Reporting Standards (ESRS).