Applying a Systems Approach to Validation and Proficiency Testing in Plant Virology to Meet ISO-17025 Accreditation Requirements
Recent changes in European Union plant health regulations require diagnostic laboratories to obtain ISO/IEC 17025 accreditation for all tests on regulated pests conducted under official controls. However, meeting all requirements of this standard is challenging due to the vast number of pest, host, and matrix combinations that require test validation and proficiency testing. In plant virology, adopting a risk-based systems approach to validation can help to meet ISO/IEC 17025 accreditation requirements. This approach acknowledges that workflows, which may consist of single or multiple tests, are used for the detection and identification of specific viruses, viroids, and phytoplasmas. For each test within a workflow, validation is determined through a risk analysis based on its specific purpose, while the entire diagnostic process is validated through the combination of tests. This approach could fit within the definition of a “flexible scope” as defined by the European co-operation for Accreditation. When combined with diagnostic expertise and contextual understanding in plant health diagnostics as well as proficiency testing at the method level, this approach improves overall diagnostic proficiency in a cost-effective way and may facilitate accreditation and compliance with plant-health regulations in the European Union.
Authors
- Sabine Grausgruber-Gröger
- C. E. de Krom
- Sebastjan Radišek (ORCID: https://orcid.org/0000-0002-9333-7985)
- Nataša Mehle (ORCID: https://orcid.org/0000-0002-3028-0280)
- Miroslava Hejlova
- Ana Belén Ruiz-García (ORCID: https://orcid.org/0000-0001-5704-2138)
- Denise Altenbach (ORCID: https://orcid.org/0000-0003-2774-2437)
- Annelien Roenhorst (ORCID: https://orcid.org/0009-0004-6029-0801)
- Antonio Olmos (ORCID: https://orcid.org/0000-0001-8406-7963)
- F. Faggioli (ORCID: https://orcid.org/0000-0002-8395-1527)
- Anne Giesbers (ORCID: https://orcid.org/0000-0001-5062-8435)
- Marcel Westenberg (ORCID: https://orcid.org/0000-0002-6458-9809)
- C. Varveri (ORCID: https://orcid.org/0000-0001-6317-0734)
- Mathieu Rolland (ORCID: https://orcid.org/0000-0002-7615-4482)
- Adrian Fox
- Michele Della Bartola (ORCID: https://orcid.org/0000-0002-6911-9208)
- Marleen Botermans (ORCID: https://orcid.org/0000-0002-7761-3855)
- C. Jeffries
- Carla Oplaat
- Anna Rosińska
- Hana Orságová
- Irena Mavrič Pleško
- Doris Gambin
- Jasna Milanović
Institutions
- Fera Science (United Kingdom) (GB)
- Scottish Agricultural Science Agency (GB)
- University of Nova Gorica (SI)
- Dutch Health Care Inspectorate (NL)
- Planta (RU)
- Cereal Research Centre (IT)
- Department of Agriculture Food and the Marine (IE)
- Instituto Valenciano de Investigaciones Agrarias (ES)
- Slovenian Institute of Hop Research and Brewing (SI)
- Central Institute for Supervising and Testing in Agriculture (CZ)
- Central Veterinary Research Laboratory (AE)
- Benaki Phytopathological Institute (GR)
- Consiglio per la ricerca in agricoltura e l’analisi dell’economia agraria (IT)
- Agricultural institute of Slovenia (SI)
- Netherlands Food and Consumer Product Safety Authority (NL)
- Département Santé des Plantes et Environnement (FR)
- Agroscope (CH)
- National Institute of Biology (SI)
- Croatian Personal Data Protection Agency (HR)
- Austrian Agency for Health and Food Safety (AT)
Publication Details
- Journal
- PhytoFrontiers™
- Published
- 2026-02-12
- DOI
- https://doi.org/10.1094/phytofr-12-25-0139-p
- Primary Topic
- Plant Virus Research Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00