Decision Rule Reporting to Comply with ISO/IEC 17025

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Abstract

Laboratories becoming familiar with the new decision rule documentation and reporting requirements of the revised ISO/IEC 17025 will first need to determine which decision rule is most appropriate for the particular situation. A flow chart is presented that covers most use cases encountered in calibration and testing. Multiple decision rule choices exist for global consumer risk use cases, requiring labs to consider the percent risk associated with the rule chosen. This paper provides calculated numeric false accept and false reject risk values for each rule and employs Monte Carlo simulations to provide visualizations of risk for several existing rules in common use. A new rule is also presented featuring additional delineation of risk that labs can easily implement and describe to end customers. For each decision rule, sample report wording is provided, to demonstrate how to

apply the rule.

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Decision Rule Reporting to Comply with ISO/IEC 17025

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