Analytical Laboratory Quality Audits are designed to improve laboratory performance. The success of the audit, as for many activities, is based on adequate preparation, precise performance, well documented and insightful reporting, and productive follow-up. Adequate preparation starts with definition of the purpose, scope, and authority for the audit and the primary standards against which the laboratory quality program will be tested. The scope and technical processes involved lead t o determining the needed audit team resources. Contact is made with the auditee and a formal audit plan is developed, approved and sent to the auditee laboratory management. Review of the auditee's quality manual, key procedures and historical information during preparation leads t o better checklist development and more efficient and effective use of the limited time for data gathering during the audit itself.
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