The Impact of Standardization on Multilateral Trade Regulation
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The Impact of Standardization on Multilateral Trade Regulation. Mario O. Wittner Chairman of CASCO INMETRO Xerem, Rio de Janeiro Brazil December 11-12, 2006. MAIN ISSUES OF THE PRESENTATION. ISO Strategic Plan 2005-2010 ISO Code of Ethics

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The Impact of Standardization on Multilateral Trade Regulation

Mario O. Wittner

Chairman of CASCO

INMETRO

Xerem, Rio de Janeiro Brazil

December 11-12, 2006


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MAIN ISSUES OF THE PRESENTATION Regulation

  • ISO Strategic Plan 2005-2010

  • ISO Code of Ethics

  • CASCO – Committee on Assessment of Conformity –

    Process Approach and Structure

  • ISO/IEC CASCO documents: adoptions to facilitate

    regulatory and voluntary trade agreements

  • The future and some concerns: “open” and “close”

  • The OECD report on Conformity Assessment


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The ISO System Regulation


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GOVERNANCE Regulation









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ISO IMPLEMENTATION PLAN RegulationOBJECTIVES 5 AND 6


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ISO Code of ethics Regulation


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CODE OF ETHICS Regulation

Promoting the implementation of International Standards and associated good conformity assessment practices.



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Study and Policy RegulationChairman’s Policy and Coordination Group (CASCO CPC)

MAIN TASKS

  • To receive mandates or requests from ISO Council, and CASCO members and other interested parties

  • To create recommendations on policies

  • To ensure fulfillment of the policies and directives

  • approved (the “Standardization Framework”)

  • To plan and assign priorities for the development

  • of standards (the “Standardization Framework”)


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ISO/CASCO CPC constitution Regulation

MEMBERS:

IEC/CAB President

7 CASCO “P”

members:

ABNT, DIN,

ICONTEC, ISIRI, ON,

SABS, SAC

CASCO Chairman


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CASCO: Promotion and Support Regulation

Regulators Interface

Group (RIG)

Vinculation with

regulators

Promotion of wider use of

CASCO documents in

Technical Regulations

context

Conformity Assessment

Promotion and Support

(CAPS)

Active role in

promoting CASCO activities

Supporting to the ISO and IEC

Technical Committes for

sectorial applications of CASCO

documents


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Use of ISO/IEC standards of CASCO Regulation

Market Feedback

Pannel (MFP)

Making surveys

on the use of

CASCO documents

Responses (yes/no) to

inquiries on

interpretation on the

appropriate use

of standards


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The Technical Work Regulation

During the 2003-2006 period, many new ISO/IEC Guides were approved (most of them coming from previous years)


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The Technical Work Regulation


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The Technical Work Regulation


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The Technical Work RegulationOn the road


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The Technical Work: the JWG with TCs RegulationOn the road (almost finished)


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ISO/IEC standards on conformity assessment Regulation

a common language to support regulatory trade agreements

through their adoption at national, regional, international and industry levels


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C A S C O D O C U M E N T S RegulationNATIONAL ADOPTIONS(CASCO/MFP Survey 2006)


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SOME EXAMPLES: Regulation

APEC – Asia Pacific Economic Cooperation

Report on the result of the 2003 VAP (Voluntary Action Plan)

Alignment (100%) with CASCO guides and standards as national standards

APEC COUNTRIES

Australia

Brunei Darussalam

Canada

Chjnese Taipei

Hong Kong China

Indonesia

Japan

Korea

Malaysia

New Zealand

Philipines Singapore

Thailand

ADOPTION OF ISO/IEC DOCUMENTS ON CONFORMITY ASSESSMENT


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COPANT/ISO/IEC 17000:2005 Regulation

COPANT/ISO/IEC 17011:2004

COPANT/ISO/IEC 17020:2002

COPANT/ISO/IEC 17024:2003

COPANT/ISO/IEC 17030:2003

COPANT/ISO/IEC 17040:2005

COPANT/ISO/IEC 17050-1:2005

COPANT/ISO/IEC 17050-2:2005

GUÍA COPANT/ISO/IEC 53:2005

GUÍA COPANT/ISO/IEC 60:2005

GUÍA COPANT/ISO/IEC 66:2002

GUÍA COPANT/ISO/IEC 67:2005

GUÍA COPANT/ISO/IEC 68:2002

REGIONAL ADOPTIONSCOPANT standards on Conformity Assessment


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Mercosur Association for Standardization Regulation

[email protected]

www.iram.org.ar

www.unit.org.uy

www.abnt.org.br

www.intn.gov.py


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Mercosur Association for Standardization Regulation

BANCO INTERAMERICANO

DE DESARROLLO

Fondo Multilateral

de Inversiones

Agreement for Regional Technical Cooperation “Project for Market Access and Integration through Standardization”


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Mercosur standards on Conformity Assessment Regulation

  • NM-ISO/IEC 17000

  • NM Guía ISO/IEC 60

  • NM-ISO/IEC 17011

  • NM Guía ISO/IEC 66

  • NM-ISO/IEC 17024

  • NM-ISO/IEC 17020

  • NM-ISO/IEC 17025

  • NM Guía ISO/IEC 65

  • NM Guía ISO/IEC 28

  • NM Guía ISO/IEC 68


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EN 45010:1998 Regulation

EN 45011:1998

EN 45012:1998

EN ISO/IEC 17000:2004

EN ISO/IEC 17011:2004

EN ISO/IEC 17020:2004

EN ISO/IEC 17024:2003

EN ISO/IEC 17025:2005

EN ISO/IEC 17040:2005

EN ISO/IEC 17050-1:2004

EN ISO/IEC 17050-2:2004

REGIONAL ADOPTIONSEuropean Standards (EN)(and therefore … national standards)


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NATIONAL ADOPTIONS RegulationUse in regulations - Argentina


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COPANT – PAN AMERICAN STANDARDS COMMISSION Regulation

SURVEY ON MANDATORY ELECTRICAL SAFETY CERTIFICATION

(1999)

REGIONAL ADOPTIONSUse in regulations


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REGIONAL ADOPTIONS RegulationUse in regulations

MERCOSUR – Subgroup Nº 3 – Technical Regulations and Conformity Assessment

  • Nº 5/92

    It recommends promotion and use of ISO 9000 Standards and ISO/IEC Guides on certification, inspection and tests

  • Nº 19/92

    It recommends use of models of ISO Certification

  • Nº 40/93

    Requirements to fulfill by product certification, processes, services and quality system bodies on the basis of ISO/IEC Guides and ISO Standards


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Use in industry sectors Regulation(just examples)




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The future and some concerns RegulationSectorial approaches in conformity assessment

(examples)

The Framework

ISO/IEC 17021

Management System

Certification Bodies

ISO 22003

Food Safety Certification

ISO/IEC FDIS 27006

Requirements for Certification

Bodies for Information

Security Management

System

ISO/IEC 28003

Supply Chain Security

Certification


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The future and some concerns RegulationWhy sectorial approaches?

  • The TCs are developing them: it is supposed they need them

  • Is there a danger of proliferation of MS standards and their certification schemes?

  • Some implications:

    • Expansion of multiple certifications

    • Need for multiple accreditations

    • New competences for management systems assessors/experts

    • The new MSS Group in ISO


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The future and some concerns RegulationNeed for revision of Guide ISO/IEC 65 - Results of the survey

ONE OF THE MAIN CRITICISM TO THE PRESENT “65” ISTHE DIFFICULT FOR USE ON THE ASSESSMENT OF SERVICES

The request to

CASCO members

(Resolution 16/2005)

22 approval

4 disapproval

The “new 65” will open a new framework for

services and products with multiple

derivations like the ones we are having now

with the 17021

If a Working Group begin to

work in 2007 the “new 65”

will be approved by

2009/2010

22nd CASCO Plenary (Buenos Aires): Revision was approved


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The future and some concerns RegulationCredibility of ISO 9001 certificationISO/IEC letter to IAF (December 1997)

  • Dear Mr. Gundlach:

  • … At the recent ISO General Assembly meeting great desappointment was expressed at the suspension of QSAR activities, as it was considered that the participation of ISO and IEC in QSAR would add international credibility to certification activities.

  • … ISO and IEC representation on your Board would provide many benefits to the international conformity assessment community as a whole, including the following:

    • It will ensure very close links between the IAF and the two organizations jointly responsible for producing the International Standards and Guides forming the basis of IAF activities, and facilitate more rapid transfer of ideas and recommendations regarding these documents.

    • It will broaden the base of the IAF and increase its authority.

    • The international status of ISO and IEC will enhance the reputation of the IAF.

    • Should the IAF consider proposing that ISO and IEC grant official recognition by permiting the use of the ISO and IEC logos, such representation would be an important consideration.


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CREDIBILITY OF ISO 9001 QUALITY Regulation

SYSTEM CERTIFICATION

  • Most complaints received in ISO are related to ISO

    9000 certification

    • They include accredited and non-accredited

      organizations

    • They include supplier’s declaration of conformity

      with ISO 9001 (without certification)

    • Auditors: the new standard (9001:2000) requires

      a greater level of competence (knowledge of the

      national quality award, strategic planning, etc.)


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CREDIBILITY OF ISO 9001 QUALITY RegulationSYSTEM CERTIFICATION

ISO Initiatives

  • ISO 9000 Advisory Group: TC 176, CASCO, COPOLCO, IAF – Brochure for purchasers – Cause analysis.

  • Ethical code for ISO and its members.

  • New ISO 17021 standard for management system certification.

  • The common elements

    • Impartiality (PAS 17001)

    • Confidentiality (PAS 17002)

    • Complaints and Appeals (PAS 17003)

    • Disclosure of Information (PAS 17004)


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The future and some concerns RegulationMarket surveillance

  • Governments, consumers, companies preoccupied for fair trade rules, are interested in market surveillance

  • The issue was presented to the CASCO Plenary in Amsterdam 2004, but did not achieve consensus for its consideration

  • Is it or not convenient to have a CASCO document for market surveillance?

  • Some CASCO members consider that this is a matter only for regulatory authorities

  • In my opinion, an International Guide or Standard, establishing unique and clear rules or, at least., orientations, will facilitate the task and contribute to avoid that market surveillance be used as a trade barrier


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The future and some concerns Regulation“open systems” vs “close systems”

  • Based on International Standards for CA systems and bodies

  • Based on International Standards or regional standards or other “consensus” normative documents for the products

  • Based on open certification and accreditation schemes: for instance ABs signatories of the MLAs and their related CBs and laboratories or open Peer Assessment Schemes

“OPEN” means:


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Open conformity assessment schemes and facilitation of trade Regulation

The IAF-ILAC-ISO MOU

(3 open organizations)

  • In March 2004 the IAF-ILAC-ISO Memorandum of Understanding (MoU) was signed by the ISO Secretary General with approval of the ISO Council.

    The MoU:

    • reaffirms ISO/IEC Standards and Guides as the source of requirements for accreditation and conformity assessment bodies and activities;

    • recognizes that IAF and ILAC may establish guidance documents to ensure consistent application by accreditors, without adding requirements;

    • establishes the IAF-ILAC-ISO JWG;

    • confirms the CASCO Secretary as JWG Secretary

    • confirms reciprocal involvement in each others work.


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Open conformity assessment schemes and facilitation of trade Regulation

… and “OPEN” means:

  • Confidence in recognized international structures

  • No “owners” of the CA schemes

  • No discriminatory entrance fees or other conditions

  • Possibility of participation in the management of the CA scheme

    Therefore: OPEN means FACILITATION OF

    TRADE


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RegulationThe CASCO/DEVCO Worshops

… and “OPEN” means AWARENESS


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RegulationThe CASCO/DEVCO Worshops

… and “OPEN” means AWARENESS


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Open conformity assessment schemes and facilitation of trade Regulation

… and “OPEN” means PARTICIPATION

… and 10 “liaisons” A


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Close Conformity Assessment(CA)Schemes Barriers to trade? Regulation

“CLOSE” means:

  • Rules for CA and specifications for the “products” developed by a person, an organization or only one interested party

  • No room for participation and consensus of other interested parties

  • Discriminatory entrance fees and conditions

  • Very difficult access, particularly for developing countries

  • Only a few selected CA bodies (or even only one)

    DOES “CLOSE” FACILITATE TRADE ?


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Organization for Economic Cooperation and Development Regulation

  • OECD Trade Policy Working Paper Nº 37 (B. Fliess and R. Schonfeld) “Trends in C.A. practices and barriers to trade – Final report on survey of CABS and exporters”

    • Responses generally confirm that CABs perceive the growing acceptance of international standards to be the single most important factor in their international expansion. This perception appears to cover both product standards and standards for conformity assessment processes. ISO has allocated much effort in recent years to a comprehensive modernisation of the body of standards which assure integrity of conformity assessment processes (often referred to collectively as CASCO standards), and this survey seems to confirm their value.


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Survey on Conformity Assessment Practices and Barriers to Trade

Some CABs responses

  • A large proportion of the products concerned appear still to be assessed in the import market

  • An important contributing factor appears to be the failure by authorities in destination markets to recognise home-country accreditation of CABs in the producer country

  • Supplier’s Declaration of Conformity (SDoC) is no having a major impact in reducing third party CA

  • The single most important factor in encouraging their cross-border activity is wider use of international standards. The widespread exhortion by governments in international trade discussions to develop and make more use of international standards does appear to have a significant positive impact.


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Survey on Conformity Assessment Practices and Barriers to Trade

  • Conformity assessment in general is not perceived today as a widespread, critical barrier to exports

  • Concern (about) technical products with complex specifications: electrical machinery, telecommunications and IT equipment

  • Complexity and delay involved in obtaining information on CA requirements in the export market targeted

Some Exporters responses


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Survey on Conformity Assessment Practices and Barriers to Trade

CABs and Exporters

  • There is widespread support for the goal of extending SDoC

  • Need of building the infrastructure necessary to make it feasible: strong structures of supplier liability (product liability law) and market surveillance

  • The most frequently mentioned “intermediate solution” is wider recognition of test reports and certificates issued in producer countries

  • The potential solutions include using non-governmental schemes more effectively. Examples of non-governmental schemes include accreditation networks based on international standards and strong peer assessment processes.

  • The potential relevance of Good Regulatory Practice (GRP) to this field also emerged


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Muito obrigado ! Trade

Muchas gracias !

Further information on conformity assessment

can be found at the following link:

http://www.iso.org/iso/en/comms-markets/conformity/iso+conformity.html


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