https://doi.org/10.1351/goldbook.08097
Process of defining an analytical requirement and confirming that the procedure under consideration has capabilities consistent with that requirement.
Notes:
- Inherent in procedure validation is the need to evaluate performance characteristics of a measurement procedure.
- The corresponding term in ISO 15189 is "validation of examination procedures".
- In ISO/IEC 17025, the term "method" is used as a synonym for measurement procedure.
- Procedure validation is either done in a single laboratory or in the framework of an interlaboratory comparison.