Burnett David
Lindens Lodge, Bradford Place, Penarth, UK.
Clin Chem Lab Med. 2006;44(6):733-9. doi: 10.1515/CCLM.2006.126.
The requirements of ISO 15189:2003 are discussed in the context of a process- and outcome-based quality management model in which the user's needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organisation and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Examples are provided from the areas of resource management, and pre-examination, examination and post-examination processes. In the final section the importance of evaluation and continual improvement is presented in relation to internal audit and external assessment, non-conformity, corrective and preventative action and management review.
ISO 15189:2003的要求是在基于过程和结果的质量管理模型背景下进行讨论的，该模型以用户需求为核心关注点。从组织和质量管理体系方面审视了ISO 15189:2003的要求，强调了证据、文件控制以及记录和临床材料控制的重要性。文中给出了资源管理、检验前、检验和检验后过程等方面的示例。在最后一部分，阐述了评估和持续改进对于内部审核和外部评估、不符合项、纠正和预防措施以及管理评审的重要性。
