The laboratory shall validate, as far as the application needs, any method it has developed, any non-standard method, and any standard method that has been modified or is used beyond its intended scope (for example through calibration or bias and precision evaluation against reference standards or materials, systematic assessment of the factors that influence results, robustness testing, comparison with other validated methods, interlaboratory comparisons, and evaluation of measurement uncertainty). If a validated method is changed, the effect of the change shall be determined and, where it affects the original validation, the method validated again. The performance characteristics of validated methods (measuring range, accuracy, uncertainty of results, limits of detection and quantification, selectivity, linearity, repeatability, reproducibility, robustness, cross-sensitivity, bias) shall be relevant to what customers need and consistent with the specified requirements. Validation records shall show the procedure followed, the requirements specified, the performance characteristics found, the results obtained, and a statement on whether the method is valid and fit for its intended purpose.
This control maps to 2 controls across 2 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.