Standards and Standardisation A practical guide for researchers Research and Innovation Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed. More information on the European Union is available on the Internet (http://europa.eu). Cataloguing data can be found at the end of this publication. Luxembourg: Publications Office of the European Union, 2013 ISBN 978-92-79-25971-5 doi: 10.2777/10323 © European Union, 2013 Reproduction is authorised provided the source is acknowledged. Cover image: © Andrea Danti, #12386685, 2012. Source: Fotolia.com Printed in Luxembourg EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR RESEARCH & INNOVATION Directorate G - Industrial technologies Standards A practical and Standardisation guide for researchers Author Dr. Peter Hatto LEGAL NOTICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. The views expressed in this publication are the sole responsibility of the author and do not necessarily reflect the views of the European Commission. More information on the European Union is available on the Internet (http://europa.eu). EUROPEAN COMMISSION Directorate-General for Research & Innovation Directorate G – Industrial Technologies Unit G1 – Horizontal Aspects E-mail: [email protected] Contact: Romain Bouttier European Commission Office CDMA 06/10 B-1049 Tel. (32-2)29-92153 Fax (32-2)9-67023 E-mail: [email protected] Contents 1 Introduction 6 1.1 Purpose of the guide ..............................................................................................................................................................................6 1.2 Roles of standards in modern society ...........................................................................................................................................6 1.3 Who makes standards and why ......................................................................................................................................................7 1.4 Standards and regulations ..................................................................................................................................................................8 1.5 Formal and informal standards ........................................................................................................................................................8 1.6 Types and examples of documents from formal standards bodies...............................................................................9 1.7 Standards as a means of disseminating and implementing the results of research.........................................12 2 Preparing for standardization 14 2.1 Recognising needs and opportunities for standardization ...............................................................................................14 2.2 Research results appropriate for standardization ................................................................................................................14 2.3 Standards versus patents – which option and why? ...........................................................................................................15 2.4 What is needed before starting? Verification and validation. .........................................................................................16 2.5 Which type of standard deliverable? ...........................................................................................................................................16 2.6 Under which standards organisation should a standard be developed? .................................................................17 2.7 Joint working between committees and between standards organisations. .........................................................18 2.8 Standardization project characterization template .............................................................................................................19 2.9 The new work item proposal and approval processes .......................................................................................................19 3 The standards development process 21 3.1 The ISO/IEC Directives and CEN/CENELEC Internal Regulations ....................................................................................21 3.2 The standards development substructure ................................................................................................................................21 3.3 The role of experts, commitment required, and the role of consensus .....................................................................23 3.4 Elements of a standard .....................................................................................................................................................................28 3.4.1 Normative and informative elements .......................................................................................................................24 3.4.2 Structural elements ............................................................................................................................................................24 3.4.3 Words with specific meaning in a standard ............................................................................................................26 3.5 Document development and review checklist .......................................................................................................................29 4 The approval and review process 28 4.1 Who, when and how ............................................................................................................................................................................28 4.2 The commenting template and types of comment.............................................................................................................29 4.3 Voting options and approval requirements ..............................................................................................................................29 4.4 Resolution of comments ...................................................................................................................................................................30 4.5 Publication ................................................................................................................................................................................................31 4.6 Systematic review – what, when and how ..............................................................................................................................31 5 Examples of successful standardization resulting from Framework Projects 33 Annex A 34 Standardization project characterization template ...........................................................................................................................34 Annex B 36 ISO and CEN NWIP forms ................................................................................................................................................................................36 ISO Form 4 .............................................................................................................................................................................................................36 CEN Form N ............................................................................................................................................................................................................39 Annex C 41 Glossary of terms ................................................................................................................................................................................................41 Annex D 43 ISO/TC 229 Welcome letter and guidance notes for PLs ..............................................................................................................43 Welcome letter .......................................................................................................................................................................................43 ISO/TC 229 Guidance for Project Leaders ..............................................................................................................................................45 Annex E 48 Document development and review checklist .....................................................................................................................................48 Annex F 54 ISO commenting template .............................................................................................................................................................................54 1 Introduction 1.1 Purpose of the guide providing agreed ways of naming, describing and specifying, measuring and testing, managing and re- This guide has been prepared for participants and pro- porting, standards provide: spective participants in EU-funded research projects and other research projects to help them identify, and ▶ basic support for commercialisation, markets and make informed choices about, opportunities to use market development; standardization for disseminating and/or implement- ▶ a recognised means for assuring quality, safety, in- ing relevant outputs from