The implementation of a (quality) management system is a proven means to render work processes transparent and reproducible, to ensure their continuous improvement, to avoid errors and, by way of accreditation according to an internationally recognised system, to produce results which are accepted worldwide.

In view of the importance of official controls in the food and feed sector, already Council Directive 93/99/EEC, Article 3, obliged the official laboratories active in this field to establish a quality assurance system. Commission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products, specified this demand by ruling that laboratories active in official residue control must provide evidence of an accreditation according to an internationally recognised quality control system. Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls (and previous Regulation (EC) No 882/2004) perpetuated the obligation to hold an accreditation for all official control laboratories active in food and feed control.

Consequently, already in the mid-90s the establishment of a quality management (QM) system in the laboratory section was initiated at the - as it was called then - EU and National Reference Laboratory for Residues of Pharmacologically Active Substances (EURL/NRL) at the Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV). In view of its prominent position within the network of European residue control laboratories, the Reference Laboratory first established a quality management system on the basis of European Standard EN 45000, complemented by OECD-GLP Elements II, No. 2 and 7. This system was accredited for the first time in 1999 by the public accreditation body Hannover (AKS) according to the regulations then in force.

After the dissolution of the BgVV and the transfer of the EURL/NRL to the newly created Federal Office of Consumer Protection and Food Safety (BVL), the laboratory section was extended and assigned new tasks and responsibilities as National Reference Laboratories (cf. Referenzlaboratoriumzuweisungsverordnung RZV [“Regulation on the allocation of reference laboratories”], last amended on 07/12/2019). With the increase in staff numbers as a consequence of the extension of its responsibilities, it became necessary to turn the laboratory section into a department in its own right (Department 5). The new organisation and the inclusion of the new tasks into the QM system also led to the further development of the technical competence of the laboratories. Successively, additional types of tests, e.g. microbiological tests and tests in the framework of the analysis of GMOs, were included into the accreditation.

Based on the laboratory accreditation according to EN 45001, the international system of laboratory accreditation underwent further development, as well. Consequently, also the BVL-internal QM system was improved continuously and adapted to the increased requirements due to the development of the relevant standards (General requirements for the competence of testing and calibration laboratories, DIN EN ISO/IEC 17025 of 2000, 2005 and, finally, 2018) and of the German accreditation system (new foundation of the German accreditation body DAkkS in 2009/10 on the basis of Regulation (EC) No 765/2008). This advancement was supported by the certification of the entire BVL according to ISO 9001:2015 (initial certification in 2012), which enabled a much better linkage between the two QM systems with regard to interdisciplinary tasks like procurement, HR and risk assessment.

The continuous further development of the QM system up to today was reflected in its successful re-accreditation according to DIN EN ISO/IEC 17025:2018 in 2019. With the inclusion of all laboratory sections into the QM system, the foundation has been laid for achieving test results of the highest possible quality as well as for their comparability and international recognition.

Proficiency tests have always been a major component of external quality control in the official control laboratories and a basis for the international comparability of test results. For this reason, proficiency tests have counted among the statutory tasks of the reference laboratories since their foundation, and have been planned, carried out and evaluated according to international standards at the BVL for many years. With the approval of ISO/IEC 17043:2010 (Conformity assessment - General requirements for proficiency testing), an accreditation as proficiency test provider became possible. For the time being, the reference laboratories are not legally required to obtain an accreditation as proficiency test provider. Nevertheless, with regard to the international acceptance of proficiency test results, the BVL strived for an accreditation according to ISO/IEC 17043:2010. For this purpose, the existing QM system was extended and adapted to these requirements. After the successful evaluation by DAkkS, the initial accreditation according to ISO/IEC 17043:2010 was granted in 2017.

In addition to that, Department 5 of the BVL has been a designated institute for the metrological traceability to the International System of Units (SI) in the analysis of food and feed, appointed by Germany's national metrology institute, the Physikalisch-Technische Bundesanstalt (PTB), since 2005. Thus, in accordance with the administrative agreement concluded with the PTB, the BVL acts as reference for the food and feed laboratories in Germany and is responsible for transferring the national standards. The traceability of the test results to SI units guarantees the comparability of analytical results and is the basis for the worldwide recognition of test reports. The current claims regarding the BVL’s calibration and measurement capabilities (CMCs) are listed in the data base of the “Bureau International des Poids et Mesures“, BIPM (https://www.bipm.org/kcdb/). In regular audits, which complement the accreditation and certification audits, the PTB checks that the tasks of a designated institute are fulfilled. In these audits, not only the adherence to DIN EN ISO/IEC 17025 is controlled, but also the laboratory’s expertise with regard to the fulfilment of the requirements of the CIPM (Comité International des Poids et Mesures). This includes the duty of the laboratory to prove its competence by regularly participating in worldwide comparative studies (key comparisons).