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Method Validation and Quality Management in the Flexible Scope of Accreditation: An Example of Laboratories Testing for Genetically Modified Organisms

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Abstract

Quality assurance is a prerequisite for accurate and reliable results in food and feed testing, ISO/IEC 17025 being recognized worldwide as the base standard. A flexible scope of accreditation enables testing laboratories to react quickly to customer demand and to cope with the large number of new methods, which have to be introduced in the laboratory. Precisely defined procedures for the validation of methods, together with performance and acceptance criteria, are the key points for flexible scope of accreditation. Testing for genetically modified organisms (GMO) is a challenging exercise, especially with more GMOs entering the world market. We describe here the organization and performance of validating quantitative detection methods for GMO testing in the context of the European Union legislation. Operational procedures for method validation organized by the Community Reference Laboratory for Genetically Modified Food and Feed, assisted by the European Network of GMO Laboratories, are described. A protocol for validating methods within an individual laboratory is proposed and discussed in terms of the requirements of flexible scope of accreditation. The system setup can be an example for other similar fields of analytical work.

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Acknowledgements

The authors thank Tina Demšar and Jana Vojvoda, for valuable discussions about single-laboratory validation, and Roger Pain for critical review of the manuscript. Work on single-laboratory validation was supported by the Slovenian Research Agency, Slovenian Ministry of Environment and Spatial Planning and Slovenian Ministry of Agriculture, Forestry and Food.

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Authors and Affiliations

  1. National Institute of Biology, Večna pot 111, 1000, Ljubljana, Slovenia

    Jana Žel, Marjana Camloh, Dejan Štebih, Katarina Cankar, Kristina Gruden & Dany Morisset

  2. European Commission, Directorate General Joint Research Centre, Institute for Health and Consumer, via E. Fermi 1-TP 331, I-21020, Ispra, (VA), Italy

    Marco Mazzara, Cristian Savini, Stephane Cordeil & Guy Van den Eede

Authors
  1. Jana Žel
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  2. Marco Mazzara
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  3. Cristian Savini
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  4. Stephane Cordeil
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  5. Marjana Camloh
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  6. Dejan Štebih
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  7. Katarina Cankar
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  8. Kristina Gruden
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  9. Dany Morisset
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  10. Guy Van den Eede
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Corresponding author

Correspondence to Jana Žel.

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Žel, J., Mazzara, M., Savini, C. et al. Method Validation and Quality Management in the Flexible Scope of Accreditation: An Example of Laboratories Testing for Genetically Modified Organisms. Food Anal. Methods 1, 61–72 (2008). https://doi.org/10.1007/s12161-008-9016-5

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  • DOI: https://doi.org/10.1007/s12161-008-9016-5

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