Qualifying Material Test
Our qualifying material test, referred to simply as, “QM,” is a way of validating microbial methods against sample matrices, ensuring that methodology is correct for testing purposes. A QM is qualifying each raw material or finished product by performing a spike of five different organisms to ensure that we can recover any of the organisms through all the testing that we do. The QM test is on our ISO accredited scope of testing as well as the methods that we routinely test. Performing this test gives the results we send out additional support as it rules out the possibility of a false negative result, or a Type 2 error. KML performs a QM on all sample lots and strongly encourage our clients to have these performed. We believe in quality and taking extra steps to ensure that the methods used are appropriate and validated for your sample matrices.
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We’ve worked closely with the FDA for years. Please allow us to better explain what tests and test methods may be required to be performed by the FDA. We are here to assist you in as many ways that we can. Our staff is friendly and always happy to help.