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International Organization for Standardization. www.iso.org. 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.
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International Organization for Standardization www.iso.org
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
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
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
An increasing demand for consensus basedinternational 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
World Trade Report 2005 Exploring the links between trade, standards and the WTO
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
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
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
The World Standards Cooperation (WSC) The leading international standardization organizations Multi-discipline and cross-sector For electrotechnology For telecommunications Collaborate to meet the challenges of converging technologies
The ISO system At January 2006 156 national members • IT tools • Standards development procedures • Consensus building • Dissemination 179 active TCs 3000 technical bodies 50 000 experts Central Secretariatin Geneva 150 staff
Yearly production of new and revised standards2001 – 2005 1 247 1 240 414 481 995 889 813 397 323 833 304 759 598 566 509 184 113 79 67 41 Revised standards New standards Standards withdrawn
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
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
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
Thank you for your attention ! http://www.iso.org