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 BfR, 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 BfR - science, assessment, communication and administration - have been certified in accordance with Quality Standard DIN EN ISO 9001 since 2010. The certificate was most recently confirmed in July 2019 by the certification body TÜV Nord Cert GmbH (see column on the right).
Quality management structures in accordance with DIN EN ISO/IEC 17025 have already been established and accredited test methods used in the BfR’s scientific laboratories since 2003. The German Accreditation Body (Deutsche Akkreditierungsstelle GmbH - DAkkS) regularly inspects the BfR and last issued an accreditation certificate with an annex of the accredited test methods in June 2018 (see column on the right).
With these certificates, the BfR documents its particularly high scientific quality standards internationally.
Certified assessment work at the BfR in accordance with DIN EN ISO 9001
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 BfR, these products are essentially 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 BfR - is taken into account and 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. Individual activities, including leadership and service processes, are laid out in so-called procedure instructions. 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 BfR (in accordance with DIN EN ISO 9001) is monitored in the form of external audits that are conducted every three years. In these audits, the BfR demonstrates its organisation, implementation and the documentation of its work processes.
Accreditation of test methods at the BfR in accordance with DIN EN/ISO IEC 17025
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 authorised 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. The technical competence and compliance with DIN EN ISO/IEC 17025 are monitored at regular intervals in independent external assessments.
For the National Reference Laboratories, located at the BfR, the accreditation of test methods is legally binding.
At the BfR, quality management in accordance with DIN EN ISO/IEC 17025 is carried out in laboratories in addition to DIN EN ISO 9001. Both quality management systems are currently merged in an integrated management system.
Quality policy of the BfR
With its quality management, the BfR pursues the following goals:
- Ensuring the best possible quality for scientific results
- Focus on people as consumers
- Setting scientific standards in consumer health protection
- Preserving organisational and content-related independence
- Ensuring economic service provision
- Safeguarding the future through forward planning and flexibility