1. 1 DSG 2007-10-23 www.iso.org International Organization for Standardization

2. 2 DSG 2007-10-23 Promoting consistency and efficiency in global rule-making Presentation by Kevin McKinley Deputy Secretary-General International Organization for Standardization UN/ECE Symposium on Trade Rules, Regulations and Standards: Different levels of rule-making and their impact Geneva, 23 October 2007

3. 3 DSG 2007-10-23 Outline of presentation The global context for consensus- based standards The contribution of ISO voluntary standards to international ‘rule- making’ International and regional efficiency International Standards and public policies Using and referencing ISO Standards

4. 4 DSG 2007-10-23 Increasing demand for consensus-based International Standards Globalization of trade in products and services Delocalization of procurement and investment Deregulation of public services Response to climate changes and energy efficiency Public demand for consumer and environmental protection and security Need for international solidarity to face terrorism, epidemics and natural disasters Deployment of new technologies and innovation

5. 5 DSG 2007-10-23 World Trade Report 2005 Exploring the links between trade, standards and the WTO

6. 6 DSG 2007-10-23 The World Standards Cooperation (WSC) Multi-discipline and cross sector For electrotechnology For telecommunications The leading international standards organizations Collaborate to meet the challenges of converging technologies

7. 7 DSG 2007-10-23 The ISO system At September 2007 IT tools Standards development procedures Consensus building Dissemination 157 national members 193 active TCs 3 041 technical bodies 50 000 experts Central Secretariat in Geneva 150 staff Collection of 16 455 ISO Standards 1388 standards produced in 2006

8. 8 DSG 2007-10-23 Some topical issues in ISO Food safety Security Environment and climate change Energy efficiency and renewable sources (energy management, bio-fuels) Services Social Responsibility Nanotechnologies Conformity assessment

9. 9 DSG 2007-10-23 ISO and the international scene WTO: observer status and collaboration UN and UN agencies: CODEX, ILO, IMO, ITC, UPU, UN/ECE, UNIDO, WHO, WMO, WTO-OMT and other IGOs (e.g., OECD, Global Harmonization Task Force for medical devices) More than 600 liaisons with international and broadly-based regional organizations Key implementers and users: Accreditors (IAF, ILAC), Consumers (CI), Standards users (IFAN), multinationals (WEF), etc…

10. 10 DSG 2007-10-23 ISO and the regional scene COPANT PASC CEN PASC ACCSQ AIDMO ARSO PASC 2005-09-07 EASC

11. 11 DSG 2007-10-23 ISO & Europe: the Vienna Agreement New Approach for eliminating TBT in the European Economic Area European legislation and importance of European Standards Single European Market Integration of the European Single Market into the global market Vienna Agreement: (signed in 1991) Facilitating the equivalence (whenever possible) of International and European standards

12. 12 DSG 2007-10-23 Increasing number of CEN Standards corresponding to ISO Standards

13. 13 DSG 2007-10-23 “International Standards and Public Policies” ISO Open Session held 20 September 2007 Sergei Ordzhonikidze, Director General, UNOG Jonathan Koppell, Yale School of Management, USA Supporting public policies for sustainable development Patricia Francis, Executive Director, International Trade Centre (ITC) Georg Kell, Executive Director, UN Global Compact (UNGC) Lord Lindsay, Chairman, United Kingdom Accreditation (UKAS) Harsha Singh, Deputy Director General, WTO Björn Stigson, President, WBCSD Masami Tanaka, Japanese Industrial Standards Committee (JISC) Public safety and security policies Marek Belka, Executive Secretary, UNECE Manfred Hennecke, German Institute for Materials Research Larry Kessler, Chairman, Global Harmonization Task Force Amb. Krister Kumlin, Chairman of ISO/TC 223, Societal security Richard Lloyd, CEO, Consumers International

14. 14 DSG 2007-10-23 Some highlights of the Open Session "Internationally agreed standards help to build capacity, open up markets, facilitate trade and nurture technological innovation.” Sergei Ordzhonikidze, Director General, UNOG Illustration of how ISO provides practical tools to support public policies and the three dimensions of sustainable world development Governments should pay attention to the emergence and growing impact of private standards on trade, especially on SMEs in developing countries New information document on “Use of ISO and IEC standards for technical regulations” acknowledged as a useful tool to assist regulators in making the best of the ISO and IEC systems

15. 15 DSG 2007-10-23 Standards and Regulations: Efficient and coordinated rule-making

16. 16 DSG 2007-10-23 Benefits for regulators! ISO Standards: allow products to be supplied and used across different markets facilitate regulatory compliance enhance market access for small enterprises; reflect the state of the art disseminate new technologies/innovative practices;

17. 17 DSG 2007-10-23 Benefits for regulators! ISO standards: consistent with expectations under WTO TBT can be used as a basis for national technical regulations are used for conformity assessment - confidence; avoid duplication / complement the regulation. can become national standards

18. 18 DSG 2007-10-23 How is it done? Success is achieved by: mutual representation at each others' meetings – formal liaison possible the acceptance of standards as a key element in the regulatory infrastructure regular communication regulator highlighting interest at earliest possible stage

19. 19 DSG 2007-10-23 How is it done? Success is achieved by: Using MOUs between appropriate groups Setting up a mechanism for formal requests for a standard Formal endorsement once it is published Synchronized publication of key documents Referring only to published ISO documents.

20. 20 DSG 2007-10-23 How is it done? Each standard should be assessed by the regulator If the standard is not satisfactory, it can be rejected. ISO Committee may revise/improve standards based on regulatory input Regulators can receive drafts of standards and be involved in their development…. …enabling them to influence and avoid having to reject.

21. 21 DSG 2007-10-23 Ships and marine technology Who? International Maritime Organization (IMO) ISO/TC 8, Ships and marine technology What? Long-term working relationship developed Over 80 formal links between IMO work and ISO standards

22. 22 DSG 2007-10-23 Transport of dangerous goods Who is involved? United Nations Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods ISO/TC 58, Gas cylinders ISO/TC 220, Cryogenic vessels

23. 23 DSG 2007-10-23 Medical devices Who is involved? Global Harmonization Task Force (GHTF) ISO/TC 210, Quality management and corresponding general aspects for medical devices

24. 24 DSG 2007-10-23 Road vehicles Who is involved? UN/ECE Working Party 29, World Forum for Harmonization of Vehicle Regulations ISO/TC 22, Road vehicles What? Of the 123 ECE regulations that exist on vehicle regulation, 56 of them now make reference to ISO standards 135 ISO standards are referenced in total

25. 25 DSG 2007-10-23 Food products Who? CODEX Alimentarius Commission ISO/TC 34 Food products What? More than 100 standards by TC 34 have now been endorsed by Codex ISO/TC 34 published ISO 22000, Food safety management systems Based on a management systems approach as well as the Codex (HACCP) system The HACCP system is widely accepted worldwide but has been implemented in different ways

26. 26 DSG 2007-10-23 In closing Many inter-governmental bodies using ISO standards effectively and efficiently Specific benefits for regulators Steps that governments can take to start successfully using ISO standards to support regulations and government initiatives Contact ISO for more information

27. 27 DSG 2007-10-23 ISO International Standards for a sustainable world Thank for your attention! http://www.iso.org