ABSTRACT
The objective of auditing a laboratory’s quality program is to evaluate the activities and existing documentation and to determine if they meet predetermined standards. A total quality program in a labo ratory is usually developed to assure that all activities are performed with the objective of meeting certain standards, both internal and external. Some standards are generated internally, e.g. corporate quality improvement process, routine quality assurance/quality con trol protocols, or annual accreditation. A corporate quality improve ment program may, in part, require that certain laboratory opera tions become routine and that customers are given information when they need it (for example, by a designated customer service contact person, facsimile capabilities, and a computerized database that can track samples). Quality assurance programs often provide standards for receiving, handling, coding, and testing samples, and for re cording and reporting results. Quality control programs usually pro vide the standards for validating instrumentation, reagents, and test procedures, and provide requirements for training of analysts.
