Quality assurance and instrumentation

Abstract

 The quality process for commercial analytical equipment starts with the selection of the vendor. It is recommended that vendors be selected who are recognized as having quality processes in place for instrument design, development, manufacturing, testing, service, and support, for example, ISO 9001 registration. When the instrument arrives in the laboratory, the installation process should follow well-documented procedures. This includes a visual inspection that the instrument is not damaged and checking that the instrument, documentation and accessories such as cables and tubings are complete. Before the instrument is used it should be verified that it meets functional and performance specification. During operation the instruments should be periodically inspected and tested, verified to meet performance, and calibrated. The instrument should be labeled with the calibration status, indicating the dates of the last successful and the next performance verification and calibration. Defective instruments should be removed from the testing area or should at least be labeled as being "out of order."