Application notes and guidance documents

The approach compares the difference between the certified and measured values with its uncertainty, i.e. the combined uncertainty of certified and measured value. Guidance on how to determine the standard uncertainties of certified values as well as standard uncertainties of measurement results is given.

Excel-files that implements ERM Application note 1: Download files

This note explains principles for the use of reference materials in analytical calibration, that is, calibration for the purpose of determining the response behaviour of analytical instruments. Issues addressed include the estimation and use of calibration uncertainty, and requirements on reference materials for calibration. ERM® are perfectly suited for this purpose, because they fulfil the stated requirements.

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This note describes the steps that need to be applied to chemical measurement methods to ensure traceability of the results. Reference materials are key to achieving traceability of measurement results. The ERM® range of certified reference materials are produce by three of Europe’s top metrology institutions. ERM® reference materials have stated traceabilities and provide a means of ensuring reliability and comparability of the results of chemical analysis.

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This application note provides information and guidance on the correct use of JRC’s Reference Materials certified for their GM (genetically modified) mass fraction of a specific GM event. It explains how the measurement system for GMO quantification in the EU context is set up.

This application note describes some practical aspects associated with handling and use of certified reference materials (CRMs) in laboratories. The various values provided on a certificate, re-use of materials, applying a moisture correction and interpretation of the traceability statement are also explained.

This application note explains the information users should collect in order to continue using a CRM beyond the validity date stated on the certificate.

Commutability is a prerequisite for reference materials (RMs) intended to be used for calibration or quality control of different measurement procedures targeting the same measurand. This application note explains the concept of commutability and clarifies the commutability information provided on the ERM certificates. In addition, this note also describes the most crucial aspects of a commutability study.

Reference Materials (RMs) and Certified Reference Materials (CRMs) are limited, sometimes expensive and not always appropriate for all purposes in a measurement process. This application note aims to acquaint end-users with the selection of the proper (C)RMs, thus supporting their correct use.

This note describes the use of ERM-DA483 for calibration of immunoassay-based in-vitro diagnostic devices.

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This manual covers proper calibration of PCR methods, estimation of measurement uncertainty, traceability of a measurement result and the way to prove the trueness of an analytical result. The manual supports the work of the JRC-hosted European Union Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF) with the ultimate aim of further improving the reporting of National Reference Laboratories (NRLs) and official GMO control laboratories within the EU.

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A guidance document on the estimation of measurement uncertainty has been compiled on request of the European Network of GMO Laboratories (ENGL) and as a follow-up of a workshop on measurement uncertainty in the GMO sector, organised by JRC in July 2005. It outlines the technical issues related to the estimation of measurement uncertainty involved in the GMO sector. In particular it gives guidance to GMO testing laboratories on how to estimate the analytical variability of quantitative analytical results obtained by real-time PCR. Two selected approaches for the estimation of measurement uncertainty are presented in detail; references to alternative approaches are given.

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The aim of this guidance document is to ensure harmonised flexible scope accreditation within Europe, according to ISO/IEC 17025:2005 related to quantitative testing of genetically modified organisms (GMOs). Considering that polymerase chain reaction (PCR) is the method of choice in the European Union (EU) for the identification and quantification of GMOs, this document refers exclusively to quantitative real-time PCR (qPCR) and GM events authorised in the EU. A validated quantification method is published by the European Union Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF) for each of the authorised events as laid down in Regulation (EC) N° 1829/2003. This document is applicable to methods for GM events which were previously authorised in the EU or which are in the authorisation process, provided that the method validation has been completed and that a certified reference material (CRM) is available as requested in the low level presence (LLP) regulation for feed. This guidance document is intended for laboratories that are acquiring or holding a flexible scope of accreditation according to ISO/IEC 17025, and aims to provide information for assessors involved in the accreditation process of these laboratories. It therefore addresses primarily laboratory managers and assessors for ISO/IEC 17025. It has been written by the members of the Task Force (TF) Flexible scope accreditation, which has been initiated by European Commission, Joint Research Centre (Geel, BE) and which reported to the European Network of GMO Laboratories (ENGL). It passed an extensive commenting phase involving the ENGL. The 2nd version of this document published in 2014 has been approved by the European co-operation for Accreditation (EA) in September 2013 as an EA guidance document.

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The aim of this guidance document is to provide a short and user-friendly support to genetic testing laboratories. It is based on internationally harmonised basic concepts and terminology for quality assurance and control (QA/QC). Relevant terms of the International Organisation for Standardisation (ISO) and the International Vocabulary of Metrology (VIM) are explained and references to other expert texts are provided. The document includes discussion and clarification of several often misunderstood issues. It takes into account the current scientific knowledge and the existing technological capabilities. This document may be revised, when appropriate, to take into account progress in science and technology.

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