Validation and verification of test methods. A dilemma in testing laboratories and accreditation audits
DOI:
https://doi.org/10.5377/universitas.v3i2.1661Keywords:
Validation of testing methods, verification of testing methodsAbstract
The main objective of this article is to clearly and simply establish the difference between validation and verification of a testing method. A brief discussion is presented on the selection and validation of testing methods as established by the ISO/IEC 17025:2005 standard. The process of method standardization is described, along with a concise overview of validation parameters as characteristic indicators of method performance, providing some brief guidelines for their application. The article also presents selected contents of standardized methods, highlighting the specifications derived from validation data. Finally, the verification process is described, emphasizing its distinction from validation, with a focus on confirming the method's specifications.
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References
1. GATT, (1994), Ronda de Uruguay sobre obstáculos técnicos al comercio. En internet: http://www.SICE - OMC - GATT Acta Final de la Ronda Uruguay.mht. Acceso el 19/10/09.
2. LA GACETA, (1996), Diario Ofi cial del Gobierno de Nicaragua. Ley 219.
3. ONA-MIFIC, Ofi cina Nacional de Acreditación. En internet: http://www.mifi c.gob.ni/dirMercados/ concredito.htm. Acceso el 16/10/09.
4. ISO/IEC 17025(ES) (2005). "Requisitos Generales para la Competencia de los Laboratorios de Ensayo y de Calibración", Norma Internacional, Ginebra, Segunda Edición.
5. ISO/IEC 15189 (E) (2007). "Requisitos particulares para la Calidad y Competencia Técnica de los Laboratorios Clínicos", Norma Internacional, Ginebra, Segunda Edición.
6. ISO/IEC 17000:2004 (ES), (2004). "Evaluación de la conformidad. Principios y vocabulario", Norma Internacional, Ginebra.
7. a) VIM 200:2008, "Vocabulario Internacional de Metrología", Edición en Español, BIPM, París.. b) ISO 9000:2005 (ES), "Sistemas de Gestión de la Calidad. Conceptos y Vocabulario", Norma Internacional, Ginebra.
8. EURACHEM/CITAC, (1998), "fi tness for purpose of analytical methods", UK.
9. ILAAC G9:2005, Guía para el uso de materiales de referencia. Acceso en Internet: http://www.organismouruguayodeacreditacion.org/IAAC.
10. FINGBERG M., (1998), "Validation de méthodes", Editorial Masson, Paris. Pag.56
11. ALACC (Criterios del Comité de Acreditación de Laboratorios Analíticos), (2007), "Requirements for Methods Verifi cations", AOAC International.
12. NATA/TN (National Association of Testing Authorities, Australia), (2009), "Guidelines for the validation and verifi cation of test methods".
13. FUNK W., DANMAMN V. y DONNVERT G, (1995), "Quality Assurance in Analytical Chemistry", VCH, Alemanis, pag. 28.
14. MILLER J.N., MILLER J.C., (2002), "Estadística y quimiometría para química analítica", Pearson Educación S.A., Madrid, pag. 127.
15. RAMIS G. y ALVAREZ-COQUE M.A., (2001), "Quimiometria", Editorial Síntesis, Madrid, pág. 124.
16. DOWALL R. D., (1999), "The role of laboratory information management systems (LIMS) in analytical method validation", Analitica Chimica Acta, 391, 149-158. https://doi.org/10.1016/S0003-2670(99)00107-5
17. ICH Q2(R1), (2005), "Validación de procedimientos analíticos".
18. ISO/TS 21748:2004, "Guidelines for the use of repeatibility, reproducibility and trueness estimates in measurement uncertainty estimation". Documento de Especifi cación técnica.
19. ISO 5725-1 (1994), "Accuracy of measurement methods and results".
20. NEUILLY M., (1998), "Controle de performances des measures industrielles", Tec- Doc, Paris, pag. 41.
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