ISO INTERNATIONAL STANDARD 17034 First edition 2016-11-01 General requirements for the competence of reference material producers Exigences generales pour la competence des producteurs de materiauxdereference Reference number ISO 17034:2016(E) ISO @IS0 2016 IS017034:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, Published in Switzerland 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 requcsted from cither iso at thc address below or Iso's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8. CP 401 CH-1214 Vernier, Geneva, Switzerland Tel.+4122 749 0111 Fax +41227490947 [email protected] www.iso.org ii IS02016-All rights reserved IS0 17034:2016(E) Contents Page Foreword .v Introduction. 1 Scope. 2 Normative references. 3 Terms and definitions. 4 General requirements. 3 4.1 Contractual matters 3 4.2 Impartiality 3 4.3 Confidentiality. 4 5 Structural requirements 4 6 Resource requirements 5 6.1 Personnel 5 6.2 Subcontracting. 6.3 Provision ofequipment, servicesand supplies 6 6.4 Facilities and environmental conditions 7 Technical and production requirements 7.1 General requirements 7.2 Production planning 7.3 Production control 8 7.4 Material handling and storage 8 7.5 Material processing. 9 7.6 Measurement procedures. 7.7 Measuring equipment. 10 7.8 Data integrity and evaluation. 10 7.9 Metrological traceability of certified values 10 7.10 Assessment of homogeneity. 11 7.11 Assessment and monitoring of stability. 11 7.12 Characterization 12 7.13 Assignment ofpropertyvalues and their uncertainties 13 7.14 RM documents and labels 14 7.15 Distribution service 15 7.16 Control ofquality and technical records 16 7.17 Management of non-conforming work 16 7.18 Complaints.... 17 8 Management system requirements 18 8.1 Options. 18 8.1.1 General... 18 8.1.2 OptionA 18 8.1.3 OptionB 18 8.2 Quality policy (Option A) 18 8.3 General management system documentation (Option A) 19 8.4 Controlofmanagement system documents (OptionA) 19 8.5 Control of records (Option A) 19 8.6 Management review (OptionA) 20 8.7 Internal audit (Option A) 20 8.8 Actions to address risks and opportunities (Option A) 21 8.9 Correctiveactions (OptionA) 21 8.9.1 General. 21 8.9.2 Cause analysis... .21 8.9.3 Selection and implementationof correctiveactions 21 8.9.4 Monitoring of corrective actions. 22 @ IS0 2016 - All rights reserved iii