The Molecular Laboratory’s Guide to ISO 15189

Quality controls are undoubtedly an essential part of laboratory life and play a key role in improving the quality of patient test results. But many labs still rely on in-house or in-kit quality controls out of the mistaken belief that independent controls are too costly or not worth the investment. However, this is about to change. With ISO 15189 already mandatory across laboratory disciplines, this regulatory requirement is on its way to global molecular labs in the very near future. And the requirement for auditing that comes with it will mean that a quality assurance policy is no longer just ‘nice to have’, but necessary.

With that in mind, molecular laboratories around the world are reconsidering the way they manage quality controls, and are now integrating independent third-party controls to their workflow. The benefits of this are clear. But why does ISO 15189 mean this needs to happen?