Quality Management

Quality assurance and quality management of products, services and processes are not only of enormous importance for the industry. Authorities, especially scientific institutions such as the BfRshort forGerman Federal Institute for Risk Assessment, must now also demonstrate that they comply with internationally recognised standards, and they must ensure such compliance by means of a functioning quality management system (QM system).

All working areas of the BfRshort forGerman Federal Institute for Risk Assessment- science, assessment, communication and administration - have been certified in accordance with Quality Standard DIN EN ISO 9001 (see certificate below). In addition, in the scientific laboratories test methods are accredited according to the DIN EN ISO/IEC 17025.

With the ISO 9001 and the accreditation certificate, the BfRshort forGerman Federal Institute for Risk Assessment documents internationally its particularly high scientific quality standards.

The standard DIN EN ISO 9001 specifies how business processes and responsibilities must be organised to guarantee the high quality of products and services. Concerning the BfRshort forGerman Federal Institute for Risk Assessment, these products are essentially for its science-based assessments of health risks posed by food, feed, consumer goods, products and substances (chemicals).

The aim is, among other things, that an organisation is systematically run on the basis of quality targets, that business processes are documented in writing and implemented in practice, that feedback from customers - i.e. all stakeholders of the assessment work conducted by the BfRshort forGerman Federal Institute for Risk Assessment - is taken into account, that scope for improvement is constantly analysed and that such improvements are then realised.

The BfR’s quality management handbook documents the quality targets, responsibilities and area of competence for the processes encountered by the institute and explains the fundamental connections between them. All applicable QM-documents, describing the BfRshort forGerman Federal Institute for Risk Assessment processes, are referenced in this handbook. This guarantees that processing of science-based risk assessments in particular and processes in general which have led to a work result can be retraced and critically reconsidered at any time.

The quality management system of the BfRshort forGerman Federal Institute for Risk Assessment (in accordance with DIN EN ISO 9001) is regularly monitored in the form of external audits and recertified every three years. In these audits, the BfRshort forGerman Federal Institute for Risk Assessment demonstrates its organisation, implementation and the documentation of its work processes.

DIN EN ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories” describes the requirements for general quality management within laboratories, which correspond to the ISO 9001 standard to a great extent. Additionally, it sets requirements for employees’ competence as well as on the test methods, facilities and preparation of test reports to ensure the validity of results. For example, by means of this system, processes and procedures in the laboratory are standardised, checked and documented, environmental conditions are defined, equipment and reagents are monitored, and employees are trained and authorized for their work.

By accrediting test methods in accordance with DIN EN ISO/IEC 17025, laboratories confirm their competence in these testing fields. Confidence in results is increased, supporting the acceptance and comparability of results from laboratories around the world. For the National Reference Laboratories, located at the BfRshort forGerman Federal Institute for Risk Assessment, the accreditation of test methods is legally binding.

The technical competence and compliance with DIN EN ISO/IEC 17025 are monitored at regular intervals in independent external assessments by the German Accreditation GmbH (DAkkS) and is confirmed with the accreditation certificate of the BfRshort forGerman Federal Institute for Risk Assessment with the registration number D-PL-18583-02-00 and the attachment

Test areas and many of the accredited test methods are listed on the accreditation certificate and attachment (see below). A current list of all test methods of the BfRshort forGerman Federal Institute for Risk Assessment is available on request and under “Test method list of the BfR”.