Hergon E
Institut national de la transfusion sanguine, Paris, France.
Transfus Clin Biol. 1998 Dec;5(6):422-30.
A quality audit is a systematic and independent examination used to determine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives. It typically applies to, but is not limited to, a quality system or elements thereof, to processes, products or services. Such audits are often called "quality system audit", "process quality audit", "product quality audit" or "service quality audit". Confidence is necessary between the quality auditor and auditees. In blood transfusion, the audit is a tool for improvement and risk management of processes, products or services.
质量审核是一种系统的、独立的检查，用于确定质量活动及相关结果是否符合计划安排，以及这些安排是否得到有效实施且适合实现目标。它通常适用于但不限于质量体系或其要素、过程、产品或服务。此类审核常被称为“质量体系审核”“过程质量审核”“产品质量审核”或“服务质量审核”。质量审核员与被审核方之间需要相互信任。在输血领域，审核是改进过程、产品或服务以及风险管理的一种工具。
