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ISOINTERNATIONALThis is a preview of "ISO 17034:2016". Click here to purchase the full version from the ANSI store.STANDARD17034First edition2016-11-01General requirements for thecompetence of reference materialproducersExigences générales pour la compétence des producteurs dematériaux de référenceReference numberISO 17034:2016(E) ISO 2016
ISO 17034:2016(E) This is a preview of "ISO 17034:2016". Click here to purchase the full version from the ANSI store.COPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any formor by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without priorwritten permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country ofthe requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. 41 22 749 01 11Fax 41 22 749 09 47copyright@iso.orgwww.iso.orgii ISO 2016 – All rights reserved
ISO 17034:2016(E) This is a preview of "ISO 17034:2016". Click here to purchase the full version from the ANSI store.Contents PageForeword.vIntroduction. vi12345678Scope. 1Normative references. 1Terms and definitions. 1General requirements. 34.1Contractual matters. 3Impartiality. 34.24.3Confidentiality. 4Structural requirements. 4Resource requirements. 56.1Personnel. 56.2Subcontracting. 5Provision of equipment, services and supplies. 66.36.4Facilities and environmental conditions. 7Technical and production requirements. 7General requirements. 77.17.2Production planning. 7Production control. 87.37.4Material handling and storage. 87.5Material processing. 9Measurement procedures. 97.67.7Measuring equipment. 10Data integrity and evaluation. 107.87.9Metrological traceability of certified values. 107.10 Assessment of homogeneity. 117.11 Assessment and monitoring of stability. 117.12 Characterization. 127.13 Assignment of property values and their uncertainties. 137.14 RM documents and labels. 147.15 Distribution service. 157.16 Control of quality and technical records. 167.17 Management of non-conforming work. 167.18 Complaints. 17Management system requirements.188.1Options. 188.1.1General. 188.1.2Option A. 188.1.3Option B. 188.2Quality policy (Option A). 188.3General management system documentation (Option A). 198.4Control of management system documents (Option A). 198.5Control of records (Option A). 198.6Management review (Option A). 208.7Internal audit (Option A). 208.8Actions to address risks and opportunities (Option A). 218.9Corrective actions (Option A). 218.9.1General. 218.9.2Cause analysis. 218.9.3Selection and implementation of corrective actions. 218.9.4Monitoring of corrective actions. 22 ISO 2016 – All rights reserved iii
ISO 17034:2016(E) This is a preview of "ISO 17034:2016". Click here to purchase the full version from the ANSI store.8.108.118.9.5Additional audits. 22Improvement (Option A). 22Feedback from customers (Option A). 22Annex A (informative) Summary of production requirements for RMs and CRMs.23Bibliography. 24iv ISO 2016 – All rights reserved
ISO 17034:2016(E) This is a preview of "ISO 17034:2016". Click here to purchase the full version from the ANSI store.ForewordISO (the International Organization for Standardization) is a worldwide federation of national standardsbodies (ISO member bodies). The work of preparing International Standards is normally carried outthrough ISO technical committees. Each member body interested in a subject for which a technicalcommittee has been established has the right to be represented on that committee. Internationalorganizations, governmental and non-governmental, in liaison with ISO, also take part in the work.ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters ofelectrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance aredescribed in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for thedifferent types of ISO documents should be noted. This document was drafted in accordance with theeditorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details ofany patent rights identified during the development of the document will be in the Introduction and/oron the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does notconstitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in theTechnical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.ISO 17034 was prepared by the ISO Committee on Conformity Assessment (CASCO), in collaboration withthe ISO Committee on Reference Materials (REMCO).This first edition of ISO 17034 cancels and r
the design of characterization, homogeneity and stability studies) is provided in ISO Guide 31 and ISO Guide 35. While the approaches outlined in ISO Guide 31 and ISO Guide 35 meet the relevant requirements of this International Standard, there might be alternative ways to achieve compliance to this International Standard.
