OMCL指导文件 设备的确认.pdf

General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (08) 73 R3 QUALIFICATION OF EQUIPMENT CORE DOCUMENT Full document title Qualification of Equipment – Core document and reference PA/PH/OMCL (08) 73 R3 Document type Guideline Legislative basis Council Directive 2001/83/EC and 2001/82/EC, as amended The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System audits of OMCLs st Date of first adoption 1 October 1999 st Date of original entry 1 February 2000 into force st Date of entry into 1 May 2017 force of revised document Previous titles/other This document replaces document PA/PH/OMCL (08) 73 2R references / last valid version Custodian The present document was elaborated by the OMCL Network / Organisation EDQM of the Council of Europe Concerned Network GEON PA/PH/OMCL (08) 73 R3 – Qualification of Equipment – Core Document QUALIFICATION OF EQUIPMENT CORE DOCUMENT Introduction 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. In order to guarantee a harmonized interpretation and application within the OMCL Network, the guideline « Qualification of Equipment » has been elaborate