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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 confirmed in 2013 by the Certification Authority TÜV Nord Cert GmbH.
The scientific laboratories of the BfR were accredited in accordance with DIN EN ISO/IEC 17025 as early as 2002. Following an appraisal, the German Accreditation Body GmbH (DAkkS) confirmed the accreditation in its certificate granted on 26 April 2013.
With the certificates, the BfR internationally documents its exceptionally high scientific quality standards and shows that the important task of consumer health protection is taken seriously.
The Quality Management System at the BfR
Quality assurance and quality management of products 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 (QMsystem).
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 the end products. In the case of the BfR, these products are essentially its science-based assessments of health risks posed by food, feed, consumer goods, products and substances (chemicals).
The goals pursued here are, 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. Used methods, procedures and tools must take as their point of reference the latest applicable standard.
All BfR employees have access to the operating procedures and apply them. A quality management handbook documents the quality targets, responsibilities and areas of competence for the processes encountered by the institute and explains the fundamental connections between them. Individual activities including leadership and support processes are laid out in so-called procedure instructions. The quality management officers of each department are expected to identify changes and problems in the individual processes at an early stage and take them into account in the 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 evaluated at any time.
The quality management system of the BfR is monitored in the form of audits which take several days to complete and are conducted every three years. In the audits, the BfR demonstrates its organisation, implementation and the documentation of its work processes.
Accredited laboratories in accordance with DIN EN SO/IEC 17025
The scientific laboratories of the BfR have been accredited in accordance with DIN EN ISO/IEC 17025 since 2002. Their accreditation proves that all organisational and technical requirements have been fulfilled and that all working results are accurately documented.
By fulfilling this standard, the laboratories implement a quality management system for their testing and calibration activities which also complies with the basic principles of DIN EN ISO 9001. However, the requirements of ISO/IEC 17025, notably in terms of technical competency, go far beyond those of ISO 9001.
Every five years, the accreditation process must be supervised. The last time compliance with the standard was supervised in November 2010. This supervision was carried out by the German Accreditation Body GmbH (DAkkS) which also issued the accreditation certificate to the BfR again on 26 April 2013.
This confirmation is an essential precondition for the recognition of laboratory findings by the research community. It was also the precondition for establishing the 14 national reference laboratories at the BfR.
Quality policy of the BfR
With its quality management, the BfR pursues the following goals:
- Ensuring the best possible quality for scientific findings
- Focus on consumer protection
- Preserving scientific independence
- Ensuring economic service delivery
- Safety in the future through forward-looking planning and flexibility
- Critical assessment and monitoring of all research findings, before they are communicated to the public or a job initiator
- Use of confirmed data and verified and / or validated methods and models; the quality management of the BfR is based on the most stringent national and international standards
- Disclosure of limits and uncertainties of any research findings