ISO-IEC_170257Bed2.07Den.pdf

Reference numberISO/IEC 17025:2005(E)ISO 2005 INTERNATIONAL STANDARD ISO/IEC17025Second edition2005-05-15General requirements for the competence of testing and calibration laboratories Exigences gnrales concernant la comptence des laboratoires dtalonnages et dessais ISO/IEC 17025:2005(E)PDF disclaimer This PDF file may contain embedded typefaces.In accordance with Adobes licensing policy,this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing.In downloading this file,parties accept therein the responsibility of not infringing Adobes licensing policy.The ISO Central Secretariat accepts 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-creation parameters were optimized for printing.Every care has been taken to ensure that the file is suitable for use by ISO member bodies.In the unlikely event that a problem relating to it is found,please inform the Central Secretariat at the address given below.ISO 2005 All 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 or ISOs member body in the country of the requester.ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel.+41 22 749 01 11 Fax +41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2005 All rights reserved ISO/IEC 17025:2005(E)ISO 2005 All rights reserved iii Contents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.2 3 Terms and definitions.2 4 Management requirements.2 4.1 Organization.2 4.2 Management system.3 4.3 Document control.4 4.3.1 General.4 4.3.2 Document approval and issue.4 4.3.3 Document changes.5 4.4 Review of requests,tenders and contracts.5 4.5 Subcontracting of tests and calibrations.6 4.6 Purchasing services and supplies.6 4.7 Service to the customer.6 4.8 Complaints.7 4.9 Control of nonconforming testing and/or calibration work.7 4.10 Improvement.7 4.11 Corrective action.8 4.11.1 General.8 4.11.2 Cause analysis.8 4.11.3 Selection and implementation of corrective actions.8 4.11.4 Monitoring of corrective actions.8 4.11.5 Additional audits.8 4.12 Preventive action.8 4.13 Control of records.9 4.13.1 General.9 4.13.2 Technical records.9 4.14 Internal audits.9 4.15 Management reviews.10 5 Technical requirements.10 5.1 General.10 5.2 Personnel.11 5.3 Accommodation and environmental conditions.12 5.4 Test and calibration methods and method validation.12 5.4.1 General.12 5.4.2 Selection of methods.13 5.4.3 Laboratory-developed methods.13 5.4.4 Non-standard methods.13 5.4.5 Validation of methods.14 5.4.6 Estimation of uncertainty of measurement.14 5.4.7 Control of data.15 5.5 Equipment.15 5.6 Measurement traceability.17 5.6.1 General.17 5.6.2 Specific requirements.17 5.6.3 Reference standards and reference materials.18 5.7 Sampling.19 ISO/IEC 17025:2005(E)iv ISO 2005 All rights reserved 5.8 Handling of test and calibration items.19 5.9 Assuring the quality of test and calibration results.20 5.10 Reporting the results.20 5.10.1 General.20 5.10.2 Test reports and calibration certificates.20 5.10.3 Test reports.21 5.10.4 Calibration certificates.22 5.10.5 Opinions and interpretations.22 5.10.6 Testing and calibration results obtained from subcontractors.23 5.10.7 Electronic transmission of results.23 5.10.8 Format of reports and certificates.23 5.10.9 Amendments to test reports and calibration certificates.23 Annex A(informative)Nominal cross-references to ISO 9001:2000.24 Annex B(informative)Guidelines for establishing applications for specific fields.26 Bibliography.27 ISO/IEC 17025:2005(E)ISO 2005 All rights reserved v Foreword ISO(the International Organization for Standardization)and IEC(the International Electrotechnical Commission)form the specialized system for worldwide standardization.National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity.ISO and IEC technical committees collaborate in fields of mutual interest.Other international organizations,governmental and non-governmental,in liaison with ISO and IEC,also take part in the work.In the field of conformity assessment,the ISO Committee on conformity assessment(CASCO)is responsible for the development of International 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 International Standard requires approval by at least 75%of the n