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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard


MODULE 2: QUALITY SYSTEM GENERAL REQUIREMENTS
Section: 5.10.2

Question:  Regarding test reports, is it required that they list the limit of detection with relation to the limit of quantitation?  The standard states that the level of uncertainty should be included, but does that mean that the LOD and LOQ must be expressly included and with relation to each other? 

TNI Response:  The Standard does not require that the relationship between the limit of detection and limit of quantitation be listed on the test report, with or without regard to any estimate of uncertainty.