ISO 15189:2003 -: Quality management, evaluation and continual improvement

被引：21

作者：

Burnett, D ^{[1
]}

机构：

[1] Lindens Lodge, Penarth CF64 1LA, S Glam, Wales

来源：

CLINICAL CHEMISTRY AND LABORATORY MEDICINE | 2006年 / 44卷 / 06期

关键词：

audit; continual improvement; management review; procedures; process; quality management;

D O I：

10.1515/CCLM.2006.126

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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.

引用

页码：733 / 739

页数：7