In-house IVDs are validated for both clinical and analytical performance. They meet the TGA's in-house IVD rules; they are assessed against the NPAAC in-house IVD requirements; validation shows they are fit for purpose and safe for patient care; the validation record states the method, the performance characteristics and the acceptance criteria; and quality assurance continues for as long as they are in use. Validation is finished before clinical use, which includes reagents labelled research-use-only or analyte-specific when their results guide patient management. The only exception is a rare or emerging condition, an uncommon application or an urgent public health situation with no validated alternative: then the report must disclose the limits of validation, a validation plan must exist, all evidence is kept, and validation is completed within one accreditation cycle unless scarce positive samples have been risk-assessed.
This control maps to 1 controls across 1 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 1 it maps to, and the evidence behind each claim, over MCP and REST.