Quality Management

Implementation of an integrated management system according to international standards at Fraunhofer IMTE

To ensure and to continuously improve the quality of its services, Fraunhofer IMTE gives top priority to the implementation of a quality management system as part of an integrated management system which based on international standards such as DIN EN ISO 13485 and DIN EN ISO/IEC 17025. The basis of the integrated management system is the following quality policy. All employees and managers of the institution have to comply with it. The quality policy is regularly reviewed and updated.

Quality policy Fraunhofer IMTE

The Fraunhofer Research Institution for Individualized and Cell-based Medical Engineering IMTE in Lübeck focuses on the integrated development of medical devices for diagnostic and therapeutic applications, as well as on technologies that address global challenges such as climate change, the decline in biodiversity, and the problem of dwindling resources and usable land while the world's population continues to grow.

With expertise in Biosensor Technology, Cell Technology, Imaging, Magnetic Methods, Mechatronics, as well as Aquaculture, Marine and Cellular Biotechnology in combination with interdisciplinary cross-sectional topics such as Additive Manufacturing, Artificial Intelligence, Systems Engineering, Modeling and Simulation, Clinical Affairs and Regulatory Affairs, Fraunhofer IMTE offers a unique portfolio of services for various industrial sectors, especially for the medical device and food industries. 

In accordance with the vision, mission and guiding principles of the Fraunhofer-Gesellschaft and as a basis for deriving the quality objectives, Fraunhofer IMTE hereby declares the following quality policy.

Fraunhofer IMTE establishes and maintains an integrated management system (IMS) based on good, professional and scientific practice and according to international standards and guidelines in the field of quality management. The management system is based on the following principles and characteristics:


Service and responsibility

We stand for applied research. We support companies in implementing innovative ideas for the benefit of society and to strengthen the German and European economy. The value of our services lies in the fact that they can be used for the benefit of people, animals and the environment. We understand our partners' requirements and ensure that we meet and - if possible - exceed them. This entails a high level of ethical, social and scientific responsibility of which we are aware and which we have made the guiding principle of our actions. The focus of our service is therefore the impartial, non-discriminatory, gender-appropriate and transparent processing of all our tasks.


Management commitment

In order to fulfill its responsibility and to ensure the satisfaction of its partners from industry and research at the same time, the top management of Fraunhofer IMTE is committed to implementing an IMS based on the standards DIN EN ISO 13485:2016 and DIN EN ISO/IEC 17025:2018 and considering other relevant normative requirements from the food and feed sector, hygiene and occupational health and safety. All management levels have a role model function in this regard. Top management is responsible for maintaining and continuously improving the management system by ensuring the necessary framework conditions. This includes, in particular, the availability of financial and human resources as well as the assignment of a top management function for the quality management of the Fraunhofer IMTE. In addition, department-specific quality managers appointed by the management coordinate the implementation and continuous improvement of the management system.


Commitment for employees

All employees of the facility are required to apply the IMS. To enable the participation of all employees, they are involved in the processes and receive appropriate and regular training on quality-related topics. These trainings promote independent, autonomous and quality-assured work at our institution. As a scientific institution, we attach great importance to the professional and personal development of our employees.


Pertinent and fact-based

We make fact-based decisions while considering the analysis of data and information. Key figures are an important tool for decision-making.


Process orientation

We think and act in terms of interrelated processes that are constantly being improved. Our workflows and the resources required for them are structured within the framework of process landscapes. Standardizable processes are documented in a traceable and reproducible manner and controlled in a hierarchical-pyramidal documentation system according to the state of the art.


Continuous improvement

We continuously improve our services, regularly review the effectiveness of our IMS and ensure its further development in line with the Plan-Do-Check-Act cycle. Various quality and risk management techniques are used for this purpose, including periodic reviews and audits, the implementation and measurement of effectiveness of corrective and preventive actions, and trend and risk analyses.