GUIDE 80 First edition 2014-08-15 Guidance for the in-house preparation of quality control materials (QcMs) Lignes directrices pour la preparation interne des materiaux de référenceutilisespourle controle qualité Referencenumber ISO GUIDE 80:2014(E) SO Copyright international Organization for Standardizatin @IS02014 networking permitted without license from IHS Not for Resale IS0GUIDE80:2014(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISOcopyrightoffice Case postale 56.CH-1211 Geneva 20 Tel. +4122 749 0111 Fax +41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IS0 2014 - All rights reserved No reproduction or networking permited without license from IHS Not for Resale ISO GUIDE 80:2014(E) Contents Page Foreword ..V Introduction. .. i 1 Scope.. 2 Normative references .... 3 Terms and definitions ..1 4 Quality control materials (QCMs) ..2 5 Applications ofquality control materials (QcMs) ..2 6 Stepsinthein-housepreparationofqualitycontrolmaterials(QCMs) ..3 7 Material specification ..4 7.1 Matrix type, matching and commutability ..4 7.2 Properties and property values .4 7.3 Unit size. .4 7.4 Total bulk amount of material .4 8 Preparation of quality control materials (QCMs) .5 8.1 Sourcing of bulk material .5 8.2 Material processing .5 8.3 Sub-division and packaging .7 9 Homogeneity .9 9.1 Overview .9 9.2 Analytical approach. .9 9.3 Statistical treatmentofhomogeneitydata .10 10 Characterization and value assignment ..12 11 Stability ..12 11.1 Overview ..12 11.2 Assessing stability ..12 11.3 Assigning an expiry date to a QCM .13 12 Transportation ..13 13 Documentationforquality control materials (QCMs) .13 13.1 General ..13 13.2 Information to be available with quality control materials (QCMs) ..13 13.3 Labellingof QCM units ..14 13.4 Useful informationto be retained .14 14 Storage ..15 14.1 General ..15 14.2 Monitoring of storage conditions .15 15 Using quality control materials (QCMs) ..15 15.1 General .15 15.2 Minimumsamplesize .15 15.3 Mixing procedure. ..15 15.4 Dry mass correction ..16 15.5 Storing opened containers of QCMs .16 AnnexA (informative)Casestudy1-PreparationofaQCMfromcoal .17 AnnexB (informative)Case study2-Preparation ofgeological ormetallurgical quality control materials (QCMs) 19 AnnexC(informative)Casestudy3-Preparationofawheatflourfortifiedwithfolicacidquality control material (QCM) 26 iii orSta lout license from IHS Not for Resale