Calibration laboratories should adhere to transition period
Deutsche Akkreditierungsstelle (DAkkS) asks all calibration laboratories working in the area of laboratory medicine to submit an application for an amendment to their accreditation. The background to this is the new harmonised edition of the standard EN ISO 15195:2019 “Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018); German version EN ISO 15195:2019” published in the Official Journal of the EU at the end of last year.
On 3 December 2020, the European Commission announced the new edition EN ISO 15195:2019 as harmonised in the Official Journal. For calibration laboratories accredited by DAkkS in the area of medical laboratories in accordance with the old edition EN ISO 15195:2003, the transition period extends until 1 July 2022. The calibration laboratories affected, which are accredited for reference measurement procedures for medical measurands, are therefore asked to submit an application for an amendment to their accreditation in good time.
To enhance the comparability of the test results produced by medical diagnostic laboratories, they should be traceable to reference materials or reference measurement procedures. These reference measurement procedures must be based on recognised measurement procedures documented step-by-step, and the measurement uncertainties must also be defined.
The general requirements for the competence of calibration laboratories are set out in DIN EN ISO/IEC 17025:2018. The ISO 15195:2018 standard is the global standard that specifies the additional aspects relating to the competence of calibration laboratories to carry out reference measurement procedures in laboratory medicine. These calibration laboratories, which are used as reference laboratories in this area, are therefore assessed by DAkkS in accordance with both standards. There are only a few laboratories in Europe that have this type of accreditation.
For Germany, the work of these laboratories is described in “RiLi-BÄK”, the guidance published by the German Medical Association concerning quality assurance in medical laboratory examinations. Calibration laboratories accredited on the basis of DIN EN ISO/IEC 17025 and DIN EN ISO 15195 have the task of determining the reference method values for interlaboratory test samples, which constitute a crucial pillar of quality assurance in medical diagnostic laboratories. The reference method values determined by these laboratories therefore represent the reference value for a very significant proportion of the quantitative medical laboratory test results produced in Germany.
As a result of the international use of the interlaboratory comparisons based on these reference method values, results of medical laboratory examinations generated using the same measurement procedure can also be compared internationally in participating countries.