Sweeney J, Heaton C
Irish Society for Quality in Healthcare, Dublin.
Int J Qual Health Care. 2000 Jun;12(3):203-9. doi: 10.1093/intqhc/12.3.203.
This paper aims to address two questions related to the implementation of the ISO 9000 Quality Management System standard in the acute health care sector: which countries have developed specific nationwide guidelines/interpretations? and what variances exist between the different interpretations of the ISO 9002 standard?
The study was carried out via an assessment of the available guideline documents for the use of ISO 9000 in the acute health care sector. The interpretation of each document was examined for common elements and deviations from the commonly agreed terms.
Worldwide in the acute health care sector (excluding that of laboratories).
Eighty-two international ISO members and/or quality health care organizations.
The results showed variation in the interpretations of the ISO 9000 standard. In total, 16 of the clauses/subclauses note distinct variations, between one or more of the documents, which could alter the perception of the system.
From examination of the six identified guideline documents, the claim that ISO 9000 introduces quality systems which are comparable from one country to another is unfounded in the acute health care sector.
本文旨在探讨与急性医疗保健部门实施ISO 9000质量管理体系标准相关的两个问题：哪些国家制定了特定的全国性指南/解释？ISO 9002标准的不同解释之间存在哪些差异？
通过评估急性医疗保健部门使用ISO 9000的现有指南文件进行研究。检查每份文件的解释，以找出共同要素以及与公认术语的偏差。
全球急性医疗保健部门（不包括实验室）。
82个国际ISO成员和/或优质医疗保健组织。
结果显示对ISO 9000标准的解释存在差异。总共有16个条款/子条款在一份或多份文件之间存在明显差异，这可能会改变对该体系的认知。
通过对六份已确定的指南文件的审查，在急性医疗保健部门，认为ISO 9000引入的质量体系在不同国家具有可比性的说法是没有根据的。
