OMCL仪器确认核心文件-中英文.docVIP

. . Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT 质量管理文件 PA/PH/OMCL (08) 73 2R QUALIFICATION OF EQUIPMENT 仪器确认 CORE DOCUMENT 核心文件 ? Full document title and reference 文件全名和索引号 Qualification of Equipment – Core document 仪器确认—核心文件 PA/PH/OMCL (08)73 2R Document type 文件类型 Guideline 指南 Legislative basis 立法基础 The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System audits of OMCLs Date of first adoption 首次采用日期 1st October 1999 Date of original entry into force 首次生效日期 1st February 2000 Date of entry into force of revised document 修订版本生效日期 1st July 2011 Previous titles/other references 曾用文件名/索引号 This document replaces document PA/PH/OMCL(08)73 R Custodian Organisation 管理组织 The present document was elaborated by the OMCL Network/EDQM of the Council of Europe Concerned Network 相关网络 GEON ?  Introduction 介绍 The standard ISO/IEC 17025 requires an appropriate choice and qualification of equipment to be used for testing purposes. Particularly, checks and calibrations before and during use and, if needed, intermediate tests (see ISO/IEC 17025 chapter 5.5.10) are necessary. ISO/IEC 17025标准要求用于检测的仪器应进行适当的选择和确认，特别是在使用前和使用中应进行检查和校正，必要时应进行中间测试（见ISO/ICE 17025 第5.5.10章节）。 In order to guarantee a harmonized interpretation and application within the OMCL Network, the guideline ? Qualification of Equipment ? has been elaborated. 为了保证在OMCL网络内的统一解释和应用，特制订此指南《仪器确认》。 From experience, the terms DQ, IQ, OQ and PQ (not explicitly mentioned by ISO/IEC 17025) have been used in a non-harmonized way amongst the different OMCLs. Therefore their mention has been avoided in this document. This does not exclude their use in OMCL’s quality systems where already approved and in application, or a reference to literature using this?nomenclature. 根据经验，术语DQ, IQ, OQ和PQ（在ISO/IEC 17025中未明确提出）已由非协调方式在不同OMCL中采用，因此在本文中避免对这些术语的使用。但这并不排除OMCL的质量体系在已批准和实际中采用这些术语，或者引用一些使用了这些术语的文献。 In order to simplify the management of the guideline, the