EDQM实验室联合审计标准指南

EDQM: PA/PH/OMCL (06) 72 (EDIV/04) 2006 年 7 月 Standard “Aide mémoire” for the Mutual Joint Au dit of Official Medicines Control Laboratories 药品官方控制实验室联合审计标准指南 I. General 一、概况 This “ aide-mémoire” was elaborated on a standard checklist for EN ISO/IEC 17025 and corresponding EA and ILAC guidelines, published by an accreditation body on the internet. Specific OMCL requirements arising from adopted OMCL guidelines were incorporated. 这个指南是为阐述《检测和校准实验室能力的通用要求》和相应的欧洲认证协会及国际实验室认可合作组织准则的一个标准清单，并被一个认证机构发表在互联网上。药品官方检验实验室的具体要求因被采用的药品官方检验实验室准则而注册成立。 This document has been revised and updated in accordance with the second edition of the EN ISO/IEC 17025 of 15th May 2005. 此文件已被修改和更新，符合了2005年5月15日第二版的《检测和校准实验室能力的通用要求》。 The questions in the first column are addressed to the testing laboratories; they are to be answered thoroughly by the laboratory itself before the evaluation takes place, with indication of corresponding reference documents (e.g. Quality Manual, SOP, working instructions etc.) to provide an efficient assessment basis to the auditors. Should any requirement of the standard be non-applicable, this must be indicated by "NA" under the "References" column and duly justified. 第一列的问题是针对测试中的实验室；要求实验室在评估开始前，根据文件和相应的参考指标全部解答，（例如：质量手册，标准操作规程，工作指示等），从而为核数师提供一个有效的评估依据。假如任何一个标准的要求不适用，则必须在参考项下注明“不适用”，并用合理的解释说明。 During the audit, this document provides a practical tool for the auditors to make sure that all elements of the ISO/IEC 17025 standard and OMCL guidelines are covered, but it will not...