Changeover to new DIN EN ISO 15189 successfully completed – DAkkS manages shortened transition period with confidence
With the publication of DIN EN ISO 15189:2023, Deutsche Akkreditierungsstelle (DAkkS) faced one of the most extensive changeovers in the field of medical laboratory diagnostics. Despite high requirements and a shortened transition period, all affected accreditations were converted on time to ensure their continued validity – thanks to the strong commitment of DAkkS staff and close cooperation with the laboratories.
The revised ISO 15189 was published in November 2022 and, as DIN EN ISO 15189:2023, adopted as an EN standard at the beginning of 2023. In autumn 2024, it was transferred to version DIN EN ISO 15189:2024 without any changes to the requirements. In the course of its publication, it became clear that as a result of the revision of the standard, a comprehensive adaptation of all affected accreditations in the field of medical laboratories was needed. Confirmation of competent fulfilment of the new requirements could only be granted after successful assessment.
Switch to new standard within a tight timeframe: DAkkS coordinates over 450 assessments and trains 120 assessors
The challenge was enormous: in addition to regular day-to-day business, around 450 assessments had to be planned and processed for the switch to new standard. This involved an increase in assessment activities of more than 50 percent in the relevant departments during the relevant period. At the same time, around 120 DAkkS assessors received training, internal documents were revised and information events for laboratory customers concerning the changeover were held.
From September 2023, a sufficient number of trained assessors were available to begin the conversion assessments. However, a large number of applications were not submitted by the laboratories until the end of May 2024, after further reminders. The EU Commission’s decision in the meantime to shorten the transition period to 20 August 2025 further intensified the situation. As a result, there was a high concentration of assessments between autumn 2024 and February 2025, followed by intensive follow-up work and decision-making until summer 2025.
DAkkS sees positive outcome to switch to new standard
On 12 August 2025, thanks to the great commitment of the DAkkS staff in technical units 3.5 and 3.7, the last certificate based on DIN EN ISO 15189:2014 was replaced by an accreditation in accordance with DIN EN ISO 15189:2023 and DIN EN ISO 15189:2024. DAkkS has therefore achieved its goal of ensuring no loss of accreditation by any medical laboratory in Germany as a result of delays with the changeover.
“Our successful completion of this extraordinary task demonstrates not only the efficiency of our new organisational structure, but also its resilience” said Uwe Zimmermann, Head of DAkkS Department 3. “We would like to thank everyone involved – both internally and externally – for their commitment and constructive cooperation.”
