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Practical sheet | REF: FIC1600 V1

Key requirements beyond ISO 9001

Author: Patrick MÉRAS

Publication date: June 10, 2017 | Lire en français

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    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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