Successful reaccreditation of the Robert Koch Institute
Despite the difficult circumstances of the pandemic, Deutsche Akkreditierungsstelle (DAkkS) confirmed the comprehensive accreditation of the Robert Koch Institute (RKI) with its handover of the accreditation certificates in mid-May 2021. As a key component of the German quality infrastructure, DAkkS thus made its contribution to quality assurance at a prominent body in the healthcare system of the Federal Republic of Germany. With the handover of the accreditation certificate, DAkkS has confirmed the reaccreditation and, in some cases, extension of RKI’s accreditations.
The accredited laboratory areas are spread over four locations and include five national reference centres and eight consulting laboratories. In addition, the HIV study laboratory and the test laboratory for disinfectant testing are also accredited. Of particular importance here is also the accreditation of the central service facilities, such as genome sequencing and the culture media centre, as their products constitute essential foundations for quality-assured work, including in the non-accredited areas of the RKI research laboratories.
Comprehensive and extensive process
The RKI has been accredited by DAkkS since 2010. From an initial four laboratories, its accreditation has been expanded over the years to 19 laboratories or organisational areas of the RKI. As it happened, the comprehensive and extremely time-consuming assessment of all laboratories and areas coincided with the outbreak of the coronavirus pandemic, and was concluded in September after two assessment intervals made up of numerous assessment days. The RKI is accredited for the implementation of testing in accordance with DIN EN ISO/IEC 17025 and laboratory diagnostic testing in accordance with DIN EN ISO 15189. This applies to the virological, bacteriological and mycological laboratories and to toxin analysis at the RKI. In addition, the RKI is also accredited as a proficiency testing provider in accordance with DIN EN ISO/IEC 17043.
Confirmation of competence at a key body in the German healthcare system
With its accreditation of the RKI, DAkkS is making a significant contribution to quality assurance in a sensitive and safety-relevant area of the healthcare system. In view of the very different scopes of the RKI’s accreditations and of the range of competences to be confirmed, DAkkS carried out a large number of assessments and deployed numerous assessors with different technical focuses for the accreditation process. The assessments took place over several days, in some cases in the form of remote assessments. The RKI is Germany’s national public health institute and is currently very much in the public eye in connection with the fight against the coronavirus pandemic. RKI’s facilities are used as reference laboratories and support the public health service with the local health authorities in Germany with the surveillance of infectious diseases, infection protection and overall health monitoring.