1. 1UN/ECE SG/cta/14112609 Date 2006-06-20 www.iso.org International Organization for Standardization

2. 2UN/ECE SG/cta/14112609 Date 2006-06-20 International Standards and Good regulatory Practice by Alan Bryden ISO Secretary-General Presentation at the UN/ECE International Forum on “Common regulatory language for global trade” Geneva, 20 June 2006

3. 3UN/ECE SG/cta/14112609 Date 2006-06-20 Outline of presentation A new global framework for technical harmonization Regulations and standards The ISO system Examples of complementarity of ISO standards and regulations Involving and assisting regulators The future ISO/IEC Guide on the use of ISO and IEC standards in relation to regulations

4. 4UN/ECE SG/cta/14112609 Date 2006-06-20 A new global framework for technical harmonization WTO : TBT, SPS and GATS (services) agreements Multiplication of regional and bilateral trade agreements: more than 200 identified by WTO Major new emerging economies (China, India, Brazil, CIS, ASEAN countries…) and regulatory reforms Good regulatory practices and reference to standards, as components of good public governance Global companies Increasing impact of societal NGOs

5. 5UN/ECE SG/cta/14112609 Date 2006-06-20 An increasing demand for consensus based international standards Globalization of trade in products and services Delocalization of procurement and investment Deregulation of public services Public demand for consumer and environmental protection Need for international solidarity to face terrorism, epidemics and natural disasters Deployment of new technologies and innovation

6. 6UN/ECE SG/cta/14112609 Date 2006-06-20 World Trade Report 2005 Exploring the links between trade, standards and the WTO

7. 7UN/ECE SG/cta/14112609 Date 2006-06-20 Technical regulations address issues such as Safety Security Health Environmental impact Accessibility Fairness of trade Consumer, user or worker information Relating to products, processes, plants, building, services or business practices

8. 8UN/ECE SG/cta/14112609 Date 2006-06-20 Complementarity between technical regulations and standards Regulations set mandatory requirements and related conformity assessment deemed necessary by the legislator for protecting citizens, the environment, infrastructures and property (intellectual, physical) Consensus based standards address technicalities and good practices for implementation, developed by a transparent process involving all the interested stakeholders International Standards may reconcile legitimate societal requirements with avoiding unnecessary technical barriers to trade

9. 9UN/ECE SG/cta/14112609 Date 2006-06-20 Standards: a toolbox for the regulators Terms and definitions Graphical symbols, pictograms and labeling Measurement, analysis and test methods Interoperability requirements Processing, validation and exchange of data Performance characteristics for safety, security, health, environmental requirements Organizational and management practices Packaging Conformity assessment

10. 10UN/ECE SG/cta/14112609 Date 2006-06-20 The World Standards Cooperation (WSC) Multi-discipline and cross-sector For electrotechnology For telecommunications The leading international standardization organizations Collaborate to meet the challenges of converging technologies

11. 11UN/ECE SG/cta/14112609 Date 2006-06-20 The ISO system At January 2006 IT tools Standards development procedures Consensus building Dissemination 156 national members 179 active TCs 3 000 technical bodies 50 000 experts Central Secretariat in Geneva 150 staff

12. 12UN/ECE SG/cta/14112609 Date 2006-06-20 Yearly production of new and revised standards 2001 – 2005 Standards withdrawnNew standardsRevised standards 813 889 995 1 247 1 240 304 323 397 414 481 509 566 598 833 759 41 184 79 67 113

13. 13UN/ECE SG/cta/14112609 Date 2006-06-20 Examples of complementarity of ISO standards with regulations Safety and motor vehicles: UN/ECE WP29 and ISO/TC22 Food safety: CODEX, WTO/SPS and the ISO 22000 series (and 300+ ISO Standards on test methods used by CODEX) Supply chain security: WCO, WMO and the ISO 28000 series Medical devises: Global Harmonization Task Force and ISO 13485 (QMS for medical device suppliers) Biometrics: ICAO, ILO and the suite of ISO standards for biometric data acquisition and interchange Conformity assessment: WTO and the ISO 17000 series

14. 14UN/ECE SG/cta/14112609 Date 2006-06-20 Involving and assisting the regulators ISO TC business plans National mirror committees ISO networking with the UN, its agencies and other International Intergovernmental Organizations Legislative reform in developing countries and economies in transition Guidance

15. 15UN/ECE SG/cta/14112609 Date 2006-06-20 The future ISO/IEC Guide on the use of ISO and IEC standards in relation with regulations Being developed under ISO/TMB and IEC/SMB Target date for publication: 2007 Typology of International Standards (IS) useful for regulators Benefits from the use of International Standards Methods for referencing and use Conformity assessment Regional examples

16. 16UN/ECE SG/cta/14112609 Date 2006-06-20 http://www.iso.org Thank you for your attention !