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GUIDE TO QUALITY IN ANALYTICAL CHEMISTRY

CITAC/Eurachem Guide

CITAC / EURACHEM GUIDE

Guide to Quality in Analytical Chemistry
An Aid to Accreditation

Prepared jointly by CITAC (The Cooperation on International Traceability in Analytical Chemistry) and EURACHEM (A Focus for Analytical Chemistry in Europe)

Edition 2002

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GUIDE TO QUALITY IN ANALYTICAL CHEMISTRYCITAC/Eurachem Guide

Guide to Quality in Analytical Chemistry An Aid to Accreditation

This document has been produced by a joint Working Group of CITAC and EURACHEM and is based on earlier documents, including CITAC Guide 1, published in 1995 and the EURACHEM WELAC Guide published in 1993. This edition deals with the new requirements of the standard ISO/IEC 17025: 1999 - "General Requirements for theCompetence of Testing and Calibration Laboratories".

Edition 2002

2

GUIDE TO QUALITY IN ANALYTICAL CHEMISTRY

CITAC/Eurachem Guide

Guide to Quality in Analytical Chemistry
An Aid to Accreditation

Published 2002

Copyright of this guide is the property of the organisations represented on CITAC and EURACHEM. This edition has been published by CITAC and Eurachem

Edition 20023

GUIDE TO QUALITY IN ANALYTICAL CHEMISTRY

CITAC/Eurachem Guide

GUIDE TO QUALITY IN ANALYTICAL CHEMISTRY CONTENTS
Section 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. Title Aims and objectives Introduction Definitions and Terminology Accreditation Scope The analytical task Specification of the analytical requirement Analytical strategy Non-routineanalysis Staff Sampling, sample handling and preparation Environment Equipment Reagents Traceability Measurement uncertainty Methods / procedures for calibrations and tests Method validation Calibration Reference materials Quality control and proficiency testing Computers and computer controlled systems Laboratory audit and review Page 5 5 7 9 11 12 13 13 13 15 16 20 21 23 24 25 28 29 32 34 36 3740

References and Bibliography Acronyms Appendices A B C

Quality Audit - Areas of Particular Importance in a Chemical Laboratory Calibration Intervals and Performance Checks Comparison Table – ISO/IEC 17025:1999 vs ISO/IEC Guide 25:1990 (ILAC G15:2001)

Edition 2002

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GUIDE TO QUALITY IN ANALYTICAL CHEMISTRY

CITAC/Eurachem Guide

1.
1.1

AIMS AND OBJECTIVES
The aim of thisguide is to provide laboratories with guidance on best practice for the analytical operations they carry out. The guidance covers both qualitative and quantitative analysis carried out on a routine or non-routine basis. A separate guide covers research and development work (CITAC/EURACHEM Guide reference A1 on page 43). The guidance is intended to help those implementing quality assurance inlaboratories. For those working towards accreditation, certification, or other compliance with particular quality requirements, it will help explain what these requirements mean. The guidance will also be useful to those involved in the quality assessment of analytical laboratories against those quality requirements. Cross-references to ISO/IEC 17025, ISO 9000 and OECD Good Laboratory Practice (GLP)requirements are provided. This document has been developed from the previous CITAC Guide 1 (which in turn was based on the EURACHEM/WELAC Guide), and updated to take account of new material and developments, particularly the new requirements of the standard, ISO/IEC 17025. This guide has been produced by a working group comprising David Holcombe, LGC, UK; Bernard King, NARL, Australia; AlanSquirrell, NATA, Australia and Maire Walsh, State Laboratory, Ireland. In addition, over the years leading to the drafting of this and earlier versions of the guide, there has been extensive input from a large number of individuals and organisations, including. CITAC, EURACHEM, EA, ILAC, AOACI, IUPAC, CCQM, and others (Refer Acronyms list on page 48). This guide concentrates on the technical issues of...