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17.16 Method Validation

The method(s) used to cer/fy the CRM must be Validated

• ISO recommends the following approaches for the validation of methods in order of preference: • The preferred method is to determine the accuracy of results the method gives on a certified National Standard (ie. NIST SRMs) • The next , more robust method, is to compare the results of the method being validated to an independent, already validated method. • The final resort ‘acceptable’ method is to have a group of outside laboratories perform a round robin check of the CRM

17.17 Method Validation

The method used to cer-fy the CRM must be Validated

• ISO 17034 brings addi2onal value to the CRM (product) by expec2ng the organiza2on to validate each method in the most robust manner possible. • This Valida2on and Traceability MUST be documented on the ISO Guide 31 prescribed Cer2ficate of Analysis