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www.iso.orgwww.iso.org

International Organization International Organization for Standardizationfor Standardization

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International Standards and International Standards and

Good regulatory PracticeGood regulatory Practice

by Alan Brydenby Alan BrydenISO Secretary-GeneralISO Secretary-General

Presentation at the UN/ECE International Forum on Presentation at the UN/ECE International Forum on

““Common regulatory language for global trade”Common regulatory language for global trade”

Geneva, 20 June 2006 Geneva, 20 June 2006

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Outline of presentationOutline 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

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A new global framework A new global framework for technical harmonizationfor 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

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An increasing demand for consensus basedAn increasing demand for consensus basedinternational standardsinternational 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

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World Trade Report 2005World Trade Report 2005

Exploring the links between trade, standards and the

WTO

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Technical regulations address issues such as 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

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Complementarity between technical regulations Complementarity between technical regulations and standardsand 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

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Standards: a toolbox for the regulatorsStandards: 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

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The World Standards Cooperation (WSC)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

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The ISO systemThe ISO system

At January 2006

• IT tools• Standards

development procedures

• Consensus building

• Dissemination

156 national members

179 active TCs3 000 technical bodies50 000 experts

Central Secretariatin Geneva150 staff

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YYearly production of new and revised standardsearly production of new and revised standards 20012001 – 2005 – 2005

0

200

400

600

800

1 000

1 200

1 400

2001 2002 2003 2004 2005

Standards withdrawnNew standardsRevised standards

813889

995

1 247 1 240

304323

397

414 481

509566

598

833759

41

184

79 67113

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Examples of complementarity of ISO standards Examples of complementarity of ISO standards with regulationswith 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

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Involving and assisting the regulatorsInvolving 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

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The future ISO/IEC Guide on the use of ISO and The future ISO/IEC Guide on the use of ISO and IEC standards in relation with regulationsIEC 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

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http://www.iso.org

Thank you for your attention !