page titel

ISO 15189:2012 and its connection to PCR tests

Everyone has been talking about PCR tests since the beginning of the Covid-19 pandemic, but how are they related to quality infrastructure? What relevance does the topic have in the context of PTB’s development cooperation? How can it be guaranteed that test results are correct, comparable and internationally recognized? The international standard ISO 15189:2012 (the German version of which is DIN EN ISO 15189:2014) describes the requirements which are being placed on the quality and competence of medical laboratories. The standard thus represents the conceptional framework.

In the context of PTB’s cooperation efforts with accreditation bodies in the Western Balkans, the requirements of the standard were explicitly broken down for the accreditation of medical laboratories for molecular SARS-CoV-2 diagnostics, i.e. applying PCR procedures. The result of this is a guideline document which stringently follows the structure and the requirements of the standard and outlines all the requirements in detail which are specific to Covid-19.

This guideline document is intended for accreditation bodies which assess PCR tests for Covid-19 as well as for the staff of medical laboratories which are responsible for molecular Covid-19 tests. The quality management system of a medical laboratory must include acceptable solutions for all critical points that are specific to Covid-19. At the same time, the document should provide information for assessors who are involved in the accreditation process of medical laboratories.


The guideline document and a downloadable PDF version (both are in English) are available here:


We would like to take this opportunity to express our sincere gratitude to the accreditation experts Aliki Stathopoulou and Ioannis Sitaras for preparing the guideline document.