EDQM 实验室合审计标准指南.docVIP

EDQM: PA/PH/OMCL (06) 72 (EDIV/04) 2006年7月Standard “Aide mémoire” for the Mutual Joint Audit 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实验室（例如：质量手册，标准操作规程，工作指示等）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 be used as such to prepare the audit report. 在审计过程中，这文件审计人员提供了实用工具，以确保所有的检测和校准实验室能力的通用要求标准药品官方检验实验室准则涵盖的内容，但不会像这样准备审计报告。This document may also be used by OMCLs as self-assessment of the implementation status of the Management System, independently of any external assessment. 《检测和校准实验室能力的通用要求这份文件作为管理系统执行情况的自我评估，独立于任何外部评估。II. Definitions and Abbreviations 二、定义和缩略词 Documents, records: documents and records can be stored in paper or electronic (computer) form. Rules must be defined for the availability of, access to and safeguarding of electronic records. 文件，记录：文件和记录可以纸张或电子（电脑）的形式存储。QM = quality manual QM =质量手册 OMCL = Official Medicines Control Labo