ISO_IEC_17043-2010.pdf

INTERNATIONALISO/IECSTANDARD17043First edition2010-02-01Conformity assessment-Generalrequirements for proficiency testingEvaluation de la conformite-Exigences generales concernant lesessais daptitudeReference number1S0/1EC17043:2010(E)ISoIEC1S020101S0/川EC17043:2010(E)PDF disclaimerThis PDF file may contain embedded typefaces.In accordance with Adobes licensing policy,this file may be printed or viewed butshall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.Indownloading this file,parties accept therein the responsibility of not infringing Adobes licensing policy.The ISO Central Secretariataccepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be found in the General Info relative to the file;the PDF-creationparameters were optimized for printing.Every care has been taken to ensure that the file is suitable for use by ISO member bodies.Inthe unlikely event that a problem relating to it is found,please inform the Central Secretariat at the address given below.COPYRIGHT PROTECTED DOCUMENTIS02010All rights reserved.Unless otherwise specified,no part of this publication may be reproduced or utilized in any form or by any means.electronic or mechanical,including photocopying and microfilm,without permission in writing from either ISO at the address below orISOs member body in the country of the requester.ISO copyright officeCase postale 56.CH-1211 Geneva 20Tel.+41227490111Fax+41227490947E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandiiISO 2010-All rights reserved1S0/1EC17043:2010(E)ContentsPageForeword.VIntroduction.V1.12Normative references.13Terms and definitions.14Technical Requirements.44.1General.4.2.4PerS0n门e4.3Equipment,accommodation and environment.54.4Design of proficiency testing schemes.,64.5Choice of method or procedure.4.610Operation of proficiency testing schemes.14.7Data analysis and evaluation of proficiency testing scheme results.124.8Reports.4.9Communication with participants.134.10.145Management requirements.155.15.2Management system.5.3165.4Review of requests,tenders and contracts.185.5Subcontracting services.195.6Purchasing services and supplies.15.7Service to the customer.205.8Complaints and appeals.205.9Control of nonconforming work.5.10205.1120C0 rrective actions.215.12Preventive actions.215.13Control of records225.14Internal auditS225.15Management reviews.23Annex A(informative)Types of proficiency testing schemes.24Annex B(informative)Statistical methods for proficiency testing.28Annex C(informative)Selection and use of proficiency testing.3539ISO 2010-All rights reservediiiIS0/川EC17043:2010(E)ForewordISO(the International Organization for Standardization)and IEC(the International ElectrotechnicalCommission)form the specialized system for worldwide standardization.National bodies that are members ofSO or IEC participate in the development of International Standards through technical committeesestablished by the respective organization to deal with particular fields of technical activity.ISO and IECtechnical committees collaborate in fields of mutual interest.Other international organizations,governmentaland non-governmental,in liaison with ISO and IEC,also take part in the work.In the field of conformityassessment,the ISO Committee on conformity assessment(CASCO)is responsible for the development ofInternational Standards and Guides.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,Part 2.Draft International Standards are circulated to the national bodies for voting.Publication as an InternationalStandard requires approval by at least 75%of the national bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights.ISO shall not be held responsible for identifying any or all such patent rights.ISO/IEC 17043 was prepared by the ISO Committee on conformity assessment(CASCO).It was circulated for voting to the national bodies of both ISO and IEC,and was approved by bothorganizations.This first edition of ISO/IEC 17043 cancels and replaces ISO/IEC Guide 43-1:1997 andISO/IEC Guide 43-2:1997,which have been technically revised.ivIs02010一All rights reserved1S0/1EC17043:2010(E)IntroductionInterlaboratory comparisons are widely used for a number of purposes and their use is increasinginternationally.Typical purposes for interlaboratory comparisons include:a)evaluation of the performance of laboratories for specific tests or measurements and monitoringlaboratoriescontinuing performance;b)identification of problems in laboratories and initiation of actions for improvement which,for example,maybe related to inadequate test or measurement procedures,effectiveness of staff training and supervision,or calibration of equipment;c)establishment of the effectiveness and comparability of test or measurement methods:dprovision of additional confidence to laboratory customers;e)identification of interlaboratory differences;f)education of participating laboratories based on the outcomes of such comparisons;9validation of uncertainty claims;h)evaluation of the performance characteristics of a method-often described as collaborative trials;Dassignment of values to reference materials and assessment of their suitability for use in specific test ormeasurement procedures;andsupport for statements of the equivalence of measurements of National Metrology Institutes through keycomparisonsand supplementary comparisons conducted on behalf of the International Bureau ofWeights and Measurement(BIPM)and associated regional metrology organizations.Proficiency testing involves the use of interlaboratory comparisons for the determination of laboratoryperformance,as listed in a)to g)above.Proficiency testing does not usually address h),i)and j)becauselaboratory competence is assumed in these applications,but these applications can be used to providendependent demonstrations of laboratory competence.The requirements of this International Standard canbe applied to many of the technical planning and operational activities for h),i)and j).The need for ongoing confidence in laboratory performance is not only essential for laboratories and theircustomers but also for other interested parties,such as regulators,laboratory accreditation bodies and otherorganizations that specify requirements for laboratories.ISO/IEC 17011 requires accreditation bodies to takeaccount of laboratoriesparticipation and performance in proficiency testing.There is a growing need forproficiency testing for other conformity assessment activities,such as inspection or product certification.Mostof the requirements in this International Standard apply to those evolving areas,especially regardingmanagement,planning and design,personnel,assuring quality,confidentiality,and other aspects,asappropriateThis International Standard has been prepared to provide a consistent basis for all interested parties todetermine the competence of organizations that provide proficiency testing.In doing so it replaces both partsof ISO/IEC Guide 43:1997.ISO/IEC Guide 43 included not only guidance on development and operation ofproficiency testing and selection and use of proficiency testing by laboratory accreditation bodies,but alsouseful descriptions of typical types of proficiency testing.This International Standard has preserved andupdated the principles for the operation of proficiency testing described in ISO/IEC Guide 43 and has retainedin Annexes A to C information on typical types of proficiency testing schemes,guidance on appropriatestatistical methods,selection and use of proficiency testing schemes by laboratories,accreditation bodies,regulatory bodies,and other interested parties.ISO 2010-All rights reserved