ISO/TC 34/SC 9/WG 7 - General requirements and guidance for microbiological examinations

This document specifies general requirements and gives guidance on microbiological examinations. It is applicable to: — the implementation of specific horizontal or vertical International Standards developed by ISO/TC 34/SC 9 or ISO/TC 34/SC 5 for detection or enumeration of microorganisms, named hereafter “specific standards”; — good laboratory practices for microbiology laboratories testing samples from the food chain; — guidance for microbiological laboratories testing samples from the food chain on the technical requirements for conforming to ISO/IEC 17025. The requirements of this general standard supersede corresponding ones in existing specific standards. Additional instructions for examinations using the polymerase chain reaction (PCR) are specified in ISO 22174. This document is applicable to examinations for bacteria, yeasts and moulds and can be used, if supplemented with specific guidance, for parasites and viruses. It does not apply to examinations for toxins or other metabolites (e.g. amines) from microorganisms. This document is applicable to microbiology of the food chain, from primary production stage to food and animal feed products, including the premises where the food or feed production and handling takes place. It is also applicable to the microbiological examination of water where water is used in food production or is regarded as a food in national legislation.

ISO 7218:2007 gives general requirements and guidance/options intended for three main uses: implementation of ISO TC34/SC9 or TC34/SC5 standards for detection or enumeration of microorganisms; good laboratory practices for food microbiological laboratories (the purpose is not to detail them in this International Standard, manuals are available for that purpose); guidance for accreditation of food microbiological laboratories (this International Standard describes the technical requirements according to Appendix B of ISO/IEC 17025:2005 for the accreditation of a microbiological laboratory by national organizations). ISO 7218:2007 covers examination for bacteria, yeasts and moulds and can be used if supplemented with specific guidance for prions, parasites and viruses. It does not cover the examination for toxins or other metabolites (e.g. amines) from microorganisms. It applies to the microbiology of food, animal feeding stuffs, the food production environment and the primary production environment. The purpose of ISO 7218:2007 is to help to ensure the validity of food microbiology examinations, to assist in ensuring that the general techniques used for conducting these examinations are the same in all laboratories, to help achieve homogeneous results in different laboratories, and to contribute towards the safety of the laboratory personnel by preventing risks of infection.