European technical guidance document for the flexible scope accreditation of laboratories quantifying GMOs
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چکیده
The aim of this guidance document is to facilitate harmonised flexible scope accreditation within Europe, according to ISO/IEC17025:2005 related to quantitative testing of genetically modified organisms (GMOs) by quantitative real-time polymerase chainreaction (qPCR) for GM events authorised in the EU or which are in the authorisation process.This document gives guidance to and is intended for laboratories that are considering to acquire a flexible scope of accreditationaccording to ISO/IEC 17025. At the same time it aims to provide information for assessors involved in the accreditation process ofthese laboratories.This guidance document has been written by members of the Task Force (TF) Flexible scope accreditation, which has been initiated byEuropean Commission, Joint Research Centre, Institute for Reference Materials and Measurements (EC JRC-IRMM, Geel, BE). After anextensive commenting phase it has been submitted to the European co-operation for Accreditation (EA) in February 2013 forconsideration as an EA guidance document. zLA-NA-2547-EN-N ISBN 978-92-79-35936-1
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Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO).
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