Dybkaer R, Jordal R, Jørgensen P J, Hansson P, Hjelm M, Kaihola H L, Kallner A, Rustad P, Uldall A, de Verdier C H
Department of Clinical Chemistry, Frederiksberg Hospital, Denmark.
Scand J Clin Lab Invest Suppl. 1993;212:60-84.
Development of quality manuals is a means for the promotion of quality in clinical laboratories by describing the total quality system. It also provides opportunity of checking whether the quality system is implemented in reality and demonstrates to the hospital administration and the clinicians that the laboratory is committed to quality. The intention of these guidelines is to describe the elements of the quality system for a large clinical laboratory, and to present such a system in the form of a quality manual. The proposed guidelines comply, where relevant, with ISO/IEC guide 25 'General requirements for the technical competence of testing laboratories' and EN 45001 'General criteria for the operation of testing laboratories'. The document may be used as an aid for laboratories wishing to be accredited according to EN 45001, or intending to apply for formal certification of their quality systems, according to ISO 9001 'Quality systems--Model for quality assurance in design/development, production, installation, and servicing' utilizing ISO 9004 'Quality management and quality system elements--guidelines; Part 2 Guidelines for service'. However, information about the minimum requirements for official recognition should be obtained from the particular accreditation or certification body concerned.
编写质量手册是通过描述全面质量体系来促进临床实验室质量提升的一种手段。它还提供了检查质量体系是否在实际中得以实施的机会，并向医院管理层和临床医生证明实验室致力于保证质量。本指南旨在描述大型临床实验室质量体系的要素，并以质量手册的形式呈现这样一个体系。所提议的指南在相关方面符合ISO/IEC指南25《检测实验室技术能力的通用要求》和EN 45001《检测实验室运作的通用准则》。本文件可作为希望依据EN 45001获得认可，或打算根据ISO 9001《质量体系——设计/开发、生产、安装和服务中的质量保证模式》利用ISO 9004《质量管理和质量体系要素——指南；第2部分 服务指南》申请其质量体系正式认证的实验室的辅助文件。然而，关于官方认可的最低要求的信息应从相关的特定认可或认证机构获取。
