Method validation
The laboratory shall validate non-standard methods and laboratory developed methods to confirm that they fit the intended use.
Instrument performance and calibration shall be verified, at least on first implementation in the practice.
The techniques used for the determination of the performance of a method should be one or a combination of:
- calibration using standards or reference materials.
- comparison with results achieved with other validated methods.
- inter-laboratory comparisons.
- systematic assessment of the factors influencing the results.
- assessment of the uncertainty of the results.