For Fresenius Medical Care, patient health and product safety means creating a safe and healthy clinical environment. The quality and safety of our products and services are the foundation of our business success. Depending on the target market and the country of production, Fresenius Medical Care is subject to different rules and regulations.
To fulfill our commitment to customer health and product safety while complying with the numerous relevant regulatory requirements, our processes are embedded in comprehensive quality management systems (QMS). These QMS enable all of our products and procedures to comply with quality and safety standards from their development to market approval, manufacturing and use in clinics through to training customers and dealing with complaints.
To allow us to provide our products and processes with a high quality, Fresenius Medical Care is committed to adhering to its Global Quality Policy, which is a key component of our QMS. The policy reflects our commitment to providing uncompromised product and service quality, while maintaining compliance with relevant regulations. By approving the Global Quality Policy, the heads of the Global Manufacturing, Quality & Supply (GMQS) and Global Research and Development (GRD) functions, who are also members of the Management Board, confirmed their commitment to implementing a harmonized quality management system and maintaining its effectiveness.
As regulatory requirements vary around the world, our QMS are managed at a regional or local level. Responsibility always lies with the Head of Quality of the corresponding region. As part of this approach, local sites are subject to management reviews and regular internal quality audits performed by personnel who are not directly involved in the processes. Furthermore, our manufacturing sites in all regions undergo external audits by notified bodies and authorities such as the U.S. Food and Drug Administration (FDA) or the German Ministry of Health. Any cases of non-conformance are forwarded to the respective department to determine and implement appropriate corrective and preventive actions in due time.