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ISO 11133:2014 from a quality assurance perspective

The new ISO 11133:2014 standard was published in May 2014 and replaces the previous standards EN ISO TS 11133-1:2009 and EN ISO TS 11133-2:2003 which separately covered preparation of culture media and performance testing of culture media. The ISO 11133:2014 standard applies to all types of media formulation, including dehydrated culture media (DCM) and ready-prepared media that are used for all applications – whether these are conventional culture or rapid methods.

ISO 11133:2014 focuses on the quality assurance of culture media, as well as specifying preparation, production and storage practices. Despite the availability of rapid detection methods, culture media are used in all microbiological tests; either as a complete stand-alone workflow, or to provide enrichment and confirmation.

Subsequently, culture liquids and solids are critical aspects of all microbiology laboratories, and as such must be fit for purpose, consistent and reproducible. By demonstrating the performance of each batch of culture media produced against a set of internationally recognised criteria, laboratories can reliably perform microbiological assessments. This new standard is normative and is therefore mandatory.

Lab M has produced a white paper on the new International Standard ISO 11133:2014 detailing the requirements of the standard and explaining the steps taken by Lab M to ensure compliance.