3. Requirements of the NF EN ISO/IEC 17025:2017 standard
Method validation is defined in the ISO/IEC 17025:2017 standard as the provision of tangible evidence that a given entity meets specified requirements (verification), where the specified requirements are appropriate for a specific purpose.
What can we take away from this definition? On the one hand, validation is a statement regarding the method’s ability to meet specific needs (a specific use). Therefore, it makes no sense to speak of the validation of a method in absolute terms. However, it is possible to evaluate a method’s performance by characterizing it. Traditionally, a method’s performance is defined by quantifying certain characteristics such as:
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Requirements of the NF EN ISO/IEC 17025:2017 standard