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 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

The ISO System

GOVERNANCE

STRATPLAN 2007: Highlights

STRATPLAN 2007: Highlights

STRATPLAN 2007: Highlights

STRATPLAN 2007: Highlights

STRATPLAN 2007: Highlights

STRATPLAN 2007: Highlights

STRATPLAN 2007: Highlights

ISO IMPLEMENTATION PLAN OBJECTIVES 5 AND 6

Each ISO player contributes to the performance ISO Code of ethics Each ISO player contributes to the performance

CODE OF ETHICS Promoting the implementation of International Standards and associated good conformity assessment practices. Promoting the implementation of International Standards to support the dissemination of technology, good practice and sustainable development, and to reduce barriers to trade Contributing to the development and promoting their adoption and fair use, in particular as far as requirements for integrity, objectivity and impartiality are concerned Implementing the requirements of (ISO/IEC) conformity assessment standards and guides in their own conformity assessment activities if they, or a body related to them, undertake such activities.

Process approach and structure

Study and Policy Chairman’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”)

ISO/CASCO CPC constitution MEMBERS: IEC/CAB President 7 CASCO “P” members: ABNT, DIN, ICONTEC, ISIRI, ON, SABS, SAC CASCO Chairman

CASCO: Promotion and Support 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

Use of ISO/IEC standards of CASCO 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

The Technical Work During the 2003-2006 period, many new ISO/IEC Guides were approved (most of them coming from previous years) ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles ISO PAS 17001:2005 Conformity assessment – Impartiality – Principles and requirements ISO PAS 17002:2004 Conformity assessment – Confidentiality – Principles and requirements ISO PAS 17003:2004 Conformity assessment – Complaints and appeals – Principles and requirements ISO PAS 17004:2005 Conformity assessment – Disclosure of information – Principles and requirements ISO/IEC 17011:2004 Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies

The Technical Work ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems ISO/IEC 1724:2003 General requirements for bodies operating certification of persons ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories ISO/IEC 17030:2003 General requirements for third-party marks of conformity ISO/IEC 17040:2005 Conformity assessment – General requirements for peer assessment of conformity assessment bodies and accreditation bodies ISO/IEC 17050-1:2004 Conformity assessment – Supplier’s declaration of conformity – Part 1: General requirements ISO/IEC 17050-2:2004 Conformity assessment – Supplier’s declaration of conformity – Part 2: Supporting documentation

ISO/IEC Guide 23:1982 (reconfirmed in 2003) The Technical Work ISO/IEC Guide 23:1982 (reconfirmed in 2003) Methods of indicating conformity with standards for third-party certification systems ISO/IEC Guide 28:2004 Conformity assessment – Guidance on a third-party certification system for products ISO/IEC Guide 53:2005 An approach to the utilization of a supplier’s quality system in third party product certification ISO/IEC Guide 60:2004 Conformity assessment – Code of good practice

The Technical Work On the road ISO/IEC 17021 Part 2 (CASCO WG 21) Conformity assessment – Requirements for third-party auditing of management systems – Management of the competence of audit teams. ISO PAS 17005 (CASCO WG 23) Conformity assessment – Use of management systems in conformity assessment – Principles and requirements ISO/IEC 17007 (CASCO WG 27) Conformity assessment – Guidelines for drafting standards and specified requirements suitable for use for conformity assessment ISO/IEC 17043 -1 (CASCO WG 28) Proficiency testing by interlaboratory comparisons – Part 1: Development and operation of proficiency testing schemes ISO/IEC 17043-2 (CASCO WG 28) Selection and use of proficiency testing schemes by laboratory accreditation bodies.

The Technical Work: the JWG with TCs On the road (almost finished) ISO 22003 (Joint CASCO-ISO/TC 34 WG 11) Food safety management systems – Requirements for bodies providing audit and certification of food safety management systems. ISO 14065 (Joint CASCO-ISO/TC 207 WG 6) Greenhouse gases – Requirements for validation and verification bodies for use in accreditation and other forms of recognition.

ISO/IEC standards on conformity assessment a common language to support regulatory trade agreements through their adoption at national, regional, international and industry levels

C A S C O D O C U M E N T S NATIONAL ADOPTIONS (CASCO/MFP Survey 2006) Standards % of countries that adopt the standard % of countries that use the adopted the standard % of countries that use the ISO documents directly Main reason(s) for adoption ISO/IEC 17025:1999 85.0 50.0 CASCO document is directly used ISO/IEC 17020:1998 60.0 35.0 ISO/IEC 17024:2003 80.0 55.0 25.0 ISO/IEC Guide 65:1996 75.0 65.0 30.0 CASCO document is directly used ISO/IEC Guide 62:1996 70.0 ISO/IEC 17011:2004 40.0

ADOPTION OF ISO/IEC DOCUMENTS ON CONFORMITY ASSESSMENT SOME EXAMPLES: 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

REGIONAL ADOPTIONS COPANT standards on Conformity Assessment COPANT/ISO/IEC 17000:2005 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

Mercosur Association for Standardization secretaria@amn.org.br www.iram.org.ar www.unit.org.uy www.abnt.org.br www.intn.gov.py

Mercosur Association for Standardization BANCO INTERAMERICANO DE DESARROLLO Fondo Multilateral de Inversiones Agreement for Regional Technical Cooperation “Project for Market Access and Integration through Standardization”

Mercosur standards on Conformity Assessment 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

REGIONAL ADOPTIONS European Standards (EN) (and therefore … national standards) 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

NATIONAL ADOPTIONS Use in regulations - Argentina Nº/Year Product Category CASCO documents cited Product Standards 92/98 Low voltage electrical equipment - ISO/IEC 28 - System Nº 5 – Accreditation: - ISO/IEC 65: Certification bodies ISO/IEC 25: Laboratories (today 17 025) IRAM (Argentina) or IEC 851/98 Safety of toys Same IRAM, COPANT, EN, ISO 319/99 Energy performance (efficiency) for refrigerators, etc. IRAM (based on ISO or IEC) 404/99 Steel products for building structures IRAM or Mercosur 896/99 Personnel Protection Equipment IRAM, Mercosur, EN, ISO

REGIONAL ADOPTIONS Use in regulations COPANT – PAN AMERICAN STANDARDS COMMISSION SURVEY ON MANDATORY ELECTRICAL SAFETY CERTIFICATION (1999) REGIONAL ADOPTIONS Use in regulations

REQUIREMENTS FOR CERTIFICATION BODIES REQUIREMENTS FOR LABORATORIES COUNTRY REGULATORY PURPOSE REQUIREMENTS FOR CERTIFICATION BODIES REQUIREMENTS FOR LABORATORIES ARGENTINA All electrical materials and household appliances Guide ISO/IEC 65 Guide ISO/IEC 28 Guide ISO/IEC 25 BRAZIL Fuses, wires and cables, medical equipment, explosive atmosphere equipment CANADA All electrical equipment CAN-P-3F (based on Guide 65) CAN-P-4C (based on Guide 25) COLOMBIA Household appliances Resolution 140 MEXICO All electrical materials, lighting and household appliances

REGIONAL ADOPTIONS Use 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

Use in industry sectors (just examples) Responsible Body ISO/IEC document Automotive IATF Guide 62 and own documents Foods EurepGap Guide 65, ISO/IEC 17 025 and own documents Telecommunications Quest Forum

Use in accreditation

Use in Peer Assessment

The future and some concerns Sectorial 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

The future and some concerns Why 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

The future and some concerns Need for revision of Guide ISO/IEC 65 - Results of the survey ONE OF THE MAIN CRITICISM TO THE PRESENT “65” IS THE 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

The future and some concerns Credibility of ISO 9001 certification ISO/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.

CREDIBILITY OF ISO 9001 QUALITY 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.)

CREDIBILITY OF ISO 9001 QUALITY SYSTEM 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)

The future and some concerns Market 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

The future and some concerns “open systems” vs “close systems” “OPEN” means: 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 conformity assessment schemes and facilitation of trade 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.

Open conformity assessment schemes and facilitation of trade … 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

…The CASCO/DEVCO Worshops … and “OPEN” means AWARENESS

…The CASCO/DEVCO Worshops … and “OPEN” means AWARENESS

Open conformity assessment schemes and facilitation of trade … and “OPEN” means PARTICIPATION … and 10 “liaisons” A

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

Organization for Economic Cooperation and Development 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.

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.

Survey on Conformity Assessment Practices and Barriers to Trade Some Exporters responses 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

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

Muito obrigado ! 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