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[荷兰实验室的良好实验室规范(GPL)与质量控制]

[Good Laboratory Practice (GPL) and quality control in Dutch laboratories].

作者信息

Goudswaard J

机构信息

Stichting Streeklaboratorium Zeeland, Goes.

出版信息

Tijdschr Diergeneeskd. 1991 Mar 15;116(6):286-95.

PMID:2028458
Abstract

A review of the origin of GLP (Good Laboratory Practice) and ISO (International Standard Organisation) directives is followed by a number of definitions of concepts such as quality, guarantees of quality, quality systems, etc. by laboratories (NEN 2653). These requirements are discussed in the paper. Certification is one of the guarantees of quality assessment by laboratories. Certification of laboratories is carried out by STERLAB (Laboratory Accreditation Board of The Netherlands) or the CCKL (National Coordination Committee for Quality Assurance for Health Care Laboratories in The Netherlands). In addition to certification, laboratories in the Netherlands are extremely active as regards external quality control (QC). QC is carried out by the various occupational groups. The paper finally closes with a discussion of future developments regarding quality control and certification in medical and veterinary diagnostic laboratories.

摘要

回顾了GLP(良好实验室规范)和ISO(国际标准化组织)指令的起源,随后是实验室(NEN 2653)对质量、质量保证、质量体系等概念的一些定义。本文对这些要求进行了讨论。认证是实验室质量评估的保证之一。实验室认证由STERLAB(荷兰实验室认可委员会)或CCKL(荷兰医疗保健实验室质量保证国家协调委员会)进行。除认证外,荷兰的实验室在外部质量控制(QC)方面也极为活跃。QC由各个职业群体开展。本文最后讨论了医学和兽医诊断实验室质量控制和认证的未来发展。

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