Validcion de metodos

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EAL

European cooperation for EAL-P11 Z VALIDATION OF TEST METHODS Accreditation of Laboratories

Publication Reference

EAL-P11

Validation of Test Methods

General principles and concepts

PURPOSE
The document is intended to give general views on certain issues related to the validation of test methods and should be seen as a common understanding and position of EAL and Eurolab.EDITION 1 Z FEBRUARY 1997

PAGE 1 OF 13

EAL-P11 Z VALIDATION OF TEST METHODS

Authorship This publication is a revision of the earlier guidance Publication ELA-G3, to cover the needs of testing and of calibration laboratories. It will henceforth be a responsibility of EAL Committee 4. Official language The text may be translated into other languages as required. The English languageversion remains the definitive version. Copyright The copyright of this text is held by EAL. The text may not be copied for resale. Guidance Publications This document represents a consensus of EAL member opinion and preferred practice on how the relevant clauses of the accreditation standards might be applied in the context of the subject matter of this document. The approaches taken are not mandatoryand are for the guidance of accreditation bodies and their client laboratories. Nevertheless, the document has been produced as a means of promoting a consistent approach to laboratory accreditation amongst EAL member bodies, particularly those participating in the EAL Multilateral Agreement. Further information For further information about this publication, contact your National member of EAL:Calibration National member Austria Belgium Denmark Finland France Germany Greece Iceland Ireland Italy Netherlands Norway Portugal Spain Sweden Switzerland BMwA BKO/OBE DANAK FINAS COFRAC DKD Ministry of Commerce ISAC NAB SIT RvA NA IPQ ENAC SWEDAC SAS Testing National member BMwA BELTEST DANAK FINAS COFRAC DAR ELOT ISAC NAB SINAL RvA NA IPQ ENAC SWEDAC SAS UKAS

United Kingdom UKAS

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EDITION 1 Z FEBRUARY 1997

EAL-P11 Z VALIDATION OF TEST METHODS

Contents
Section Page

0 1 2 3 4 5

Foreword Introduction General principles to be used in validation Validation procedure Definitions References and background material

4 4 4 8 10 13

EDITION 1 Z FEBRUARY 1997

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EAL-P11 Z VALIDATION OF TEST METHODS

0
0.1

Foreword
EAL and Eurolab havea Permanent Liaison Group (PLG), which is a forum where EAL and Eurolab are discussing matters of mutual interest. The PLG consists of five members from each organisation. This document has been prepared in the PLG and endorsed by both organisations. The document is intended to give general views on certain issues related to the validation of test methods and should be seen as a commonunderstanding and position of EAL and Eurolab. In order to define and describe the activities behind the concept 'Validation of test methods' more detailed guidance documents are needed. This document should be seen as a basis for such guidance document

0.2 0.3

1
1.1

Introduction
The definition used for 'validation' in the ISO standard 8402 is 'confirmation by examination and provision ofobjective evidence that the particular requirements for a specific intended use are fulfilled'. This definition gives the impression of confined and well-defined (exact) operations. Test methods are normally developed for an intended application range. The reference to particular requirements must in many cases be interpreted in a flexible way as the requirements can be of general nature. Bothstandardised and non-standardised test methods are covered. They can be exact or associated with large uncertainties. Even novel test methods will be considered. The validation of a test method becomes in this context a way of demonstrating that the method is fit for its intended purpose. The fitness for purpose includes an assessment and a balancing of technological possibilities, risks and costs. There...
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