The safety of our patients is our priority, and it plays a central role in our management approaches. Patient safety and the unrestricted operation of healthcare facilities can be at risk from various factors. For example, disruptions in the process flow, such as natural disasters or technical failure, pose a risk to patients and the healthcare facilities. In addition, there are operational risks, for example potential hygiene deficiencies, that could jeopardize product safety and the health of patients. We counter these risks through structured processes, training, and quality management systems, among other things, and work to continuously improve patient and product safety. Transparent information for the public is also part of our safety and quality commitment. The potential consequences that non-financial risks can have for Fresenius are described in our Opportunities and Risk Report.

In the following, we explain our approach to patient and product safety. In addition, this section covers specific information from the market segments healthcare products (Fresenius Kabi) and healthcare services (Fresenius Helios and Fresenius Vamed).

Our goals and ambitions

The application of the highest possible quality and safety standards, the effectiveness of products and service offerings, and adherence to regulatory assessment and compliance requirements are essential prerequisites to support our ambition: to secure long-term corporate success and enable the care of patients. To achieve this, we set ourselves specific targets in the business segments.

These targets are part of the short-term variable compensation of the Management Board. Further information can be found in this chapter as well as in the Compensation Report in the Annual Report 2023.

Our approach

At Fresenius, our aspiration is to provide patients with the best possible care. Therefore, we offer medical treatments and products that meet our strict requirements for quality and safety. It is essential for the safety and well-being of our patients that we appropriately label our products, describe our services in a transparent manner, and provide all relevant information to patients or their relatives in our healthcare facilities. For healthcare professionals, relevant information on pharmaceutical products or medical equipment is provided through dedicated communication channels, for example websites, and trained experts from our business segments. Training also encompasses acting with integrity and responsibility with third parties, if required for an individual function or an area of responsibility.

Organization and responsibilities

Within the Group Management Board, the Board member responsible for Legal, Compliance, Risk Management, ESG, Human Resources and for the business segment Fresenius Vamed steers strategic Group-wide provisions within his responsibilities. The Chief Executive Officers (CEOs) of the business segments are responsible for operational management. The responsibility for patient and product safety or quality management and quality assurance, respectively, is regulated by the respective Management Board committees or managements, e. g., via a business allocation plan. The business allocation plan of the Group Management Board does not provide for a separate department for this purpose. As part of risk reporting, the Group Management Board is informed quarterly. The effectiveness of the quality management systems is discussed, if risks were identified or incidents occurred that could have a significant impact on the operating business, the reputation, or the value chain of the Group and its business segments. The Audit Committee of the Supervisory Board is informed about developments on a half-year basis, the Supervisory Board on an annual basis. For further information, please refer to the Opportunities and Risk Report and to the Compliance section.

In the business segments, employees must ensure that the applicable quality and safety regulations are always applied in their areas of responsibility. The employees in the production facilities, outpatient centers, and hospitals have a special obligation to exercise due care. The organizational structures and controls are adapted to the requirements of the individual business segments.

In the area of quality management, we monitor, manage, and improve processes with the support of performance indicators. Our quality management systems meet and are based on various standards or are adapted to them, because the requirements differ for healthcare facilities and for the development, production, and distribution of pharmaceuticals or even medical-technical products. We use different applications, such as externally provided IT systems or self-developed applications, to support our quality management systems.

Training courses for our employees, which are an essential part of guaranteeing the safety of our patients, interacting respectfully with them, and the safety of our products, are an important component of our quality management systems. Further information on employee training can be found in the Employees chapter under Employee development.

Product developments or their improvements are explained in the Research and development section of the Group Management Report and the Innovation chapter.

Guidelines and regulations

We comply with the applicable laws within quality management. Internationally applicable frameworks are particularly important for product quality at our production sites and distribution centers and subsequently also for product safety. We assess the effectiveness of our management systems based on key performance indicators (KPIs) which are explained in the following.

In our clinics and healthcare facilities, we apply internationally recognized standards from the hospital sector and local regulatory requirements and laws for the outpatient and inpatient care of patients, e. g., the Fifth Book of the Social Code (SGB V) in Germany, which regulates basic requirements for quality assurance. We measure the quality of patient care, patient safety and, patient satisfaction with various indicators. In addition, hygiene provisions in our healthcare facilities are monitored based on specific parameters.

Depending on the business area and market, we are subject to further specific regulatory requirements and standards. This includes legislation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the Restriction of Hazardous Substances (RoHS), and the Medical Device Regulation (MDR), among other standards. In addition, we have to adhere to regulations that specify products used in patient treatments, e. g., product safety provisions with regard to hazardous materials in single-use products in hospitals.

In addition, the business segments follow their own guidelines, which contain concrete instructions for specific processes. Responsible marketing, advertising, and sales in our product segments are controlled via internal guidelines and external regulatory provisions applicable to healthcare companies. For our healthcare services business, ethical marketing regulation applies based on regulatory provisions regarding reimbursement schemes by healthcare authorities and insurance providers. These provisions are also incorporated into our compliance guidelines in our business segments. Information on this is provided in the Compliance section and our Opportunities and Risk Report.

Our commitment to patients’ health and well-being is reviewed and certified by external partners or regulatory bodies. We are continuously expanding the number of sites certified to ISO 9001 standard, applicable internationally acknowledged care or hospital standards, or quality standards provided for centers of expertise for certain areas of treatment. All new hospitals are subject to this certification process in the year following their opening or takeover. In Spain, 94% of hospitals were certified according to ISO 9001 in the reporting year. Further clinics have also implemented reporting in accordance with this standard.

Not all locations have the same scope of certifications, as the coverage at business segment level depends on the standards or specifications to be applied. However, at the very least they adhere to internal quality standards, which consider the applicable regulatory provisions. In addition to the standards of the International Organization for Standardization (ISO), we use the following quality principles or standards, among others:

• the methodology of the Initiative for Quality Medicine (IQM), the model of the European Foundation for Quality Management (EFQM), the standards of the Joint Commission International (JCI), and the Spanish Association for Standardisation UNEUNEThe ​Spanish ​Association ​for ​Standardization, ​UNE, ​is ​the ​body ​legally ​responsible ​for ​the ​development ​of ​standards ​in ​Spain. ​It ​is ​the ​Spanish ​representative ​in ​ISO., for healthcare facilities, and
• Good Manufacturing Practice (GMP), current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP), Guideline on Good Pharmacovigilance Practices (GVP), MDR, the Code of Federal Regulations (CFR) of the U.S. Food and Drug Administration (FDA), and
• the ISO 13485 quality management standard for medical devices in our production business.

The Fresenius Group quality management approach is controlled by internal specialists or dedicated functions within the business segments. Relevant data is reviewed regularly, in some cases daily. If deviations occur, our specialists initiate root cause analyses or peer reviews; they evaluate deviations and, if necessary, determine corrective or preventive actions. Regular internal audits and self-inspections – at least annually – as well as external reviews and audits, support data verification and management approaches, for certified and non-certified entities. In this way, we ensure that patient health activities comply with internal guidelines and regulatory provisions. The overarching ambition is to enhance the efficiency and coverage of our quality management systems and, ultimately, the credibility of the procedures and systems in place.