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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
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
CODE OF ETHICS Promoting the implementation of International Standards and associated good conformity assessment practices.
Study and PolicyChairman’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)
The Technical Work: the JWG with TCsOn the road (almost finished)
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)
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 ADOPTION OF ISO/IEC DOCUMENTS 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 REGIONAL ADOPTIONSCOPANT standards on Conformity Assessment
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
EN 45010:1998 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)
COPANT – PAN AMERICAN STANDARDS COMMISSION SURVEY ON MANDATORY ELECTRICAL SAFETY CERTIFICATION (1999) REGIONAL ADOPTIONSUse in regulations
REGIONAL ADOPTIONSUse 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
The future and some concernsSectorial 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 concernsWhy 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 concernsNeed 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
The future and some concernsCredibility 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.
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.)