Skip to content

GRI 416/3-3, 417/3-3

The safety of our patients is our highest priority, and it plays a central role. In our medical services, for example, disruptions in the process flow, such as natural disasters or technical failure, pose a significant risk to patients and the healthcare facilities. In addition, there are also operational risks, for example due to potential hygiene deficiencies. 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 these and other non-financial risks can have for Fresenius are described in detail in our Opportunities and Risk Report.

In the following, we explain our approach to patient and product safety. In addition, this chapter covers specific information from the business segments:

Our approach

GRI 416/3-3, 417/3-3

At Fresenius, our aspiration is to provide patients with the best possible care. Therefore, we offer them 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.

Organization and responsibilities

Within the Fresenius Group Management Board, the Chief Executive Officers (CEOs) of the business segments are responsible for operational management. The responsibility for quality management and quality assurance is regulated by the respective Management Board committees or managements, e. g., via a business allocation plan. The business allocation plan of the Fresenius Group Management Board does not provide for a separate department for this purpose. As part of risk reporting, the Fresenius Group Management Board is informed quarterly about the effectiveness of the quality management systems, i.e. about risks or incidents 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 of these developments on a quarterly 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 are adapted to the requirements of the individual business segments.

In the area of quality management, we monitor, manage, and improve processes with 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. All locations are subject to regular, e. g., annual, external and internal audits. Additionally, we carry out peer reviews in our hospitals, if the internal quality targets of a hospital are not met. This is done whenever the evaluation of the quality indicators reveals deviations from the internal targets. The results of these audits or peer reviews for each business segment are presented in the evaluation sections of this chapter.

Training courses for our employees, which are an essential part of guaranteeing the safety of our patients and products, are an important component of our quality management systems.

Further information on employee training can be found in the Employee development section.

Policies and regulations

GRI 2-23

The business segments comply with the applicable laws within the framework of quality management. Internationally applicable frameworks are particularly important for ­product quality at our production sites and distribution centers and subsequently also for product safety. In our clinics and healthcare facilities, we apply internationally recognized standards from the hospital sector, local­regulatory 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 as well as the patient satisfaction with various indicators.

Depending on the business area and market, we are subject to further specific regulatory requirements and standards. This includes legislation on the Registration, Evaluation, Authorization 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 apply their own comprehensive guidelines, which serve as internal orientation, and 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 health distributors, for further information please see the SASB index. For our healthcare service business, ethical marketing regulation applies based on regulatory provisions regarding reimbursement schemes by healthcare authorities and insurance providers. These provisions are also incorporated in our compliance guidelines in our business segments. Information is provided in the section Compliance and our Opportunities and Risk Report.

Certifications and commitment

GRI 416-1

Our commitment to patients’ health and well-being in the business segments is reviewed and certified by external partners or regulatory bodies. We are continuously expanding the number of sites certified to ISO 9001 standard, applicable international acknowledged care or hospital standards, or quality standards provided for centers of exp­ertise for certain areas of treatment. 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 (FDAFDA (U.S. Food & Drug Administration)Official ​authority ​for ​food ​observation ​and ​drug ​registration ​in ​the ​United ​States.), and the ISO 13485 quality management standard for medical devices in our production business of Fresenius Medical Care and Fresenius Kabi.

Certification overview

Download(XLS, 35 KB)
Certification or standard Group coverage1
External standard 100%
Thereof ISO 9001  61%
Internal standard or policies 100%
Regulatory requirements (e. g., national law) 100%
1 Coverage within the business segments depends on the applicability of standards or policies. 

In 2022, four further locations were added to ISO 9001 (2021: six). In addition, Helios Spain received the Joint Commission International Enterprise gold seal. With this award, the company has become the first private hospital group in the world to have this accreditation, as well as the first healthcare operator in Europe.

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, often at higher frequencies – support data verification and management approaches, for certified and non-certified entities. Thus, we ensure that patient health activities comply with internal guidelines and regulatory provisions. The overarching ambition is to imp­rove the efficiency and coverage of our quality management systems and, ultimately, the credibility of the procedures and systems in place.

In 2022, 77% of the production sites of Fresenius Medical Care managed by the Manufacturing and Supply Chain division were certified to ISO 9001 or 13485. The business segment regularly carries out internal audits following a risk-based approach.

Quality standards Fresenius Medical Care

Download(XLS, 35 KB)
Quality standard ISO 9001/13485 GMP/cGMP MDSAP
Production sites certified1 (%) 77 46  29
1 Production sites managed by the Manufacturing and Supply Chain division. 

Fresenius Kabi’s quality management system is­ ­organized in accordance with the ISO 9001 standard and is binding for all organizations of the business segment. Compliance with the standard is reviewed by TÜV SÜD in annual audits at a global level and covers 120 Fresenius Kabi organizations through a matrix certification; one further organization holds a local ISO 9001 certificate. In addition, numerous manufacturing plants have supplementary certifications, such as ISO 13485 for medical devices, food safety management system according to ISO 22000 or GMP in general for pharmaceuticals.

Quality standards Fresenius Kabi

Download(XLS, 35 KB)
Quality standard ISO 9001 ISO 13485 GMP/cGMP
Number of certified entities 108 25 50
Number of certified entities1 (%) 90 100 100
1 Coverage target 100% of relevant entities, variation due to organizational changes, e. g., opening, closing of locations; %-coverage subject based on entities for which the standard is of relevance.

Helios Germany applies the German Inpatient Quality IndicatorInpatient Quality IndicatorThe ​Inpatient ​Quality ​Indicator ​at ​Fresenius ​Helios ​comprises ​the ​measurement ​of ​a ​set ​of ​standardized ​¬German ​inpatient ​quality ​indicators ​(G-IQI). ​These ​are ​based ​on ​routinely ​collected ​hospital ​billing ​data ​from ​hospital ​information ​systems. ​The ​number ​of ​indicators ​achieved ​compared ​to ​the ​total ​number ​of ​indicators ​is ​calculated ​to ​measure ​the ​overall ​success ​rate. ​There ​is ​individual ​target ​setting ​and ​measurement ​of ​target ​achievement ​in ​the ​two ​Helios ​segments ​Helios ​Germany ​and ​Helios ​Spain. ​Subsequently, ​target ​achievement ​is ​consolidated ​at ​Helios ​company ​level ​with ​equal ​weighting ​(50% ​each) ​for ​Executive ​Board ​compensation. ​ (G-IQI) management system in all German clinics. Newly acquired entities are integrated into this management system from the start of the acquisition. Further certifications encompass the acknowledgment as centers of medical expertise, e. g., for oncology, diabetes, endoprosthetics, or others.

Helios Spain also gears its quality management toward the requirements of recognized international quality standards. All hospitals and centers are certified according to ISO Standard 9001 and continued to be certified according to the Spanish Association for Standardization, UNE, or other relevant standards in the hospital sector, e. g., JCI or EFQM standards. Fundación Jiménez Díaz was the first hospital in the world to receive the EFQM Global award. It has obtained more than 750 points, which also gives it the EFQM 7 Stars seal, the highest score for this standard.

Quality standards Fresenius Helios

Download(XLS, 35 KB)
Quality standard ISO 9001 IQM
Number of certified entities 49 136
Number of certified entities (%)1 100 100
1 %-Coverage based on entities for which the standard is of relevance. ISO 9001 applies to Spain only.

Fresenius Vamed aligns its internal processes to established quality standards such as ISO 9001, the sector-specific standard EN15224 for quality management in healthcare, and ISO 13485, as well as the EFQM standards. In addition, Fresenius Vamed has certified several healthcare facilities according to international standards such as JCI, ISO, or the German QMS-REHA (Qualitätsmanagementsystem der Deu­tschen Rentenversicherung Bund für Reha-Kliniken). All inpatient rehabilitation facilities in Germany must be certified in accordance with a procedure recognized by the Federal Association for Rehabilitation (Bundesarbeitsgemeinschaft für Rehabilitation e. V. – BAR), such as QMS-REHA. All certifications form the basis for the continuous improvement of the processes at Fresenius Vamed.

In total, 100% of the entities of Fresenius Vamed are covered by an external quality standard, based on the aforementioned various applicable certifications and regulatory provisions.

Quality standards Fresenius Vamed

Download(XLS, 35 KB)
Quality standard ISO 9001 ISO 13485 JCI/Other
Number of certified entities 29 14 3
Number of certified entities (%)1 74 100 8
1 %-Coverage based on entities for which the standard is of relevance.