1. The Impact of Standardization on Multilateral Trade Regulation
Mario O. Wittner
Chairman of CASCO
INMETRO
Xerem, Rio de Janeiro Brazil
December 11-12, 2006

2. MAIN ISSUES OF THE PRESENTATION
ISO Strategic Plan
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

3. The ISO System

4. GOVERNANCE

6. STRATPLAN 2007: Highlights

7. STRATPLAN 2007: Highlights

8. STRATPLAN 2007: Highlights

9. STRATPLAN 2007: Highlights

10. STRATPLAN 2007: Highlights

11. STRATPLAN 2007: Highlights

12. STRATPLAN 2007: Highlights

13. ISO IMPLEMENTATION PLAN OBJECTIVES 5 AND 6

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

20. 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.

21. Process approach and structure

22. 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”)

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

24. 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

25. 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

26. The Technical Work
During the 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

27. 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 :2004
Conformity assessment – Supplier’s declaration of conformity – Part 1: General requirements
ISO/IEC :2004
Conformity assessment – Supplier’s declaration of conformity – Part 2: Supporting documentation

28. 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

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

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

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

32. 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

33. 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

34. 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 :2005
COPANT/ISO/IEC :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

35. Mercosur Association for Standardization

36. 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”

37. 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

38. 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 :2004
EN ISO/IEC :2004

39. NATIONAL ADOPTIONS Use in regulations - Argentina
Nº/Year
Product Category
CASCO documents cited
Product Standards
92/98
Low voltage electrical equipment
- ISO/IEC System
Nº 5 – Accreditation:
- ISO/IEC 65: Certification bodies
ISO/IEC 25: Laboratories (today )
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

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

41. 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

42. 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

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

44. Use in accreditation

45. Use in Peer Assessment

46. 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

47. 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

48. 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

49. 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.

50. 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.)

51. 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 standard for management system certification.
The common elements
Impartiality (PAS 17001)
Confidentiality (PAS 17002)
Complaints and Appeals (PAS 17003)
Disclosure of Information (PAS 17004)

52. 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

53. 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

54. 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.

55. 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

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

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

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

59. 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 ?

60. 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.

61. 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.

62. 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

63. 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

64. Muito obrigado ! Muchas gracias !
Further information on conformity assessment
can be found at the following link: