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17.18 Method Validation

The method used to cer-fy the CRM needs to include Quality Control Samples

• ISO 17034 brings value to the CRM (product) by requiring the manufacturer to analyze a Quality Control Sample concurrently with the Analytical Sample, to demonstrate the proper execution of the method. • Statistical Control Techniques chart, plot and analyze QC activity from lot to lot .

17.19 Method Validation

ISO 17034 further requires the CRM producer to provide the Uncertainty Value for each CRM.

• To correctly establish the Uncertainty Value for each CRM, an Error Budget needs to be created. • The Error Budget takes into account all Fixed and Random Errors associated with that analysis. • Uncertainty must be defined on the CerCficate of Analysis. It’s mathemaCcal expression and all fixed and random errors are taken into account. • ISO 17034 CRM requires that the producer include the Uncertainty of the CerCfied Value on the CerCficate of Analysis.