This guideline is intended for individuals and laboratories that perform medical testing and focuses on general and service-specific equipment, instruments, and analytical systems. Recommendations for establishing criteria and methods for all aspects of equipment operation-including selection, identification, validation, reverification, use, and decommission of equipment-are provided.
Although the requirements for the quality system essential (QSE) Equipment include those for computer system hardware, middleware, and software, guidance for meeting those requirements is provided in other documents and CLSI documents AUTO08, AUTO11, and GP19.
A detailed description of acquisition options is beyond the scope of this document.