3. What does the standard require in terms of validating test methods and estimating measurement uncertainties?
Adapted (or alternative), non-standardized or laboratory-developed methods must be duly validated, and a declaration of the method's suitability for its intended use must be made by the laboratory.
3.1 Validation definitions
VIM gives the following definition: "verification, where the specified requirements are adequate for a given use".
ISO/IEC 17025 states that "validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specified intended use are fulfilled".
These definitions require :
setting requirements in the form of acceptability criteria relating to accuracy and precision;
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What does the standard require in terms of validating test methods and estimating measurement uncertainties?
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Bibliography
Document LAB-REF-02 - Requirements for laboratory accreditation to NF EN ISO/CEI 17025
CITAC/EURACHEM Guide to quality in analytical chemistry Accreditation support
Food and Drug Administration (FDA) - Guidance for Industry - Part 11 - Electronic Records ; Electronic Signatures - Scope and Application
...
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ToolAnalyst" function sheet (Tool ...
Websites
Bureau international de métrologie légale (BIPM)
The intergovernmental organization whose Member States act in common on matters relating to measurement science and measurement standards.
Comité français d’accréditation (CoFRAC)
CoFRAC, created in...
Reference standards
ISO 9001:2008 - Quality management systems – Requirements
ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories
FD X07-019:2000 - Customer/Supplier relations in metrology
NF EN ISO 10012:2003 - Measurement management systems - Requirements for measurement...
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