New rule document for medical laboratories published
After completion of the consultation process, Deutsche Akkreditierungsstelle (DAkkS) has published the new “Rule for accreditation of medical laboratories in accordance with DIN EN ISO 15189:2023” (R-15189) on its website and put it into force.
For administrative practice, the rule fleshes out the provisions of the standard DIN EN ISO 15189:2023, which specifies general requirements for the competence of medical laboratories and serves as the central basis for their accreditation. In addition to DAkkS rule R-17011 and where required for medical laboratories, the new rule also sets out the requirements of DIN EN ISO/IEC 17011:2018 applicable to the accreditation procedure in greater detail.
Important to know: the provisions of the new rule build directly on the text of the standard. The rule does not reiterate the content of the standard and provides no comprehensive explanations, information or reasons for the specifications contained in the document. The standard itself is a document protected by copyright that is available for purchase from DIN Media (formerly Beuth Verlag).
What changes as a result of rule R-15189?
The new rule R-15189 entails no substantive changes in terms of accreditation practice, but rather provides more detailed definitions where necessary. R-15189 fleshes out the provisions of the standard version DIN EN ISO 15189:2023. The essential basis for the accreditation of medical laboratories is the standard itself.
Requirements of international rules of the organisations European co-operation for Accreditation (EA) and International Laboratory Accreditation Cooperation (ILAC) for the accreditation of medical laboratories, which were previously part of horizontal DAkkS rules, have been incorporated into the new rule R-15189.
For the presentation of the flexible scope of accreditation, the current requirements apply until further notice. DAkkS will in future designate the categories for more flexible scopes of accreditation as A, B and C, gradually replacing the previous classifications as III, I and II.
In future, the new category designations will make it evident that they build on each other hierarchically and follow a comparable presentation across all DAkkS accreditation activities. DAkkS will provide further details on the introduction and information on sectoral arrangements on its website in good time.
The category designations will make it evident in the future that the categories build on each other hierarchically and ensure a comparable presentation in all DAkkS accreditation activities.
The DAkkS body of rules
With rule R-15189, DAkkS is moving forward with the next important element of its new approach to rules. Further rules concerning the basic standards for the various conformity assessment activities are currently being prepared. Consultations on these draft rules are also planned, with a view to giving interested parties the opportunity to express their opinion.
