Introduction and Scope
Microbiological testing includes sterility testing, detection, isolation, enumeration, and identification of microorganisms (viruses, bacteria, fungi, and protozoa) and their metabolites, or any kind of assay using microorganisms as part of a detection system as well as the use of microorganisms for ecological testing.
According to Reg (EU) 2017/625 for food and feed [6] and Dir (EU) 2020/2184 [7] for water intended forhuman consumption, laboratories in Member States shall have a quality management system in place, documented according to ISO/IEC 17025[1] and including validated, and wherever possible accredited test methods. Note that also laboratories outside the EU shall fulfil the criteria when providing certificatesaccompanying food.
This guide provides laboratories carrying out microbiological testing with appropriate information on howto fulfil the requirements of ISO/IEC 17025, giving detailed guidance on such requirements. Although thisguide is written primarily for food, water, and environmental microbiological testing, the general principles may be applied to other areas.
