1. USAid presentation, Bishkek, Kyrgyzstan
The international technical infrastructure and the International Organization for Standardization (ISO)
Graeme Drake, ISO Central Secretariat, Geneva
12-14 November 2002,
Hyatt Regency Hotel
Bishkek, Kyrgyzstan
The international technical infrastructure - Graeme Drake, ISO

2. 5 topics… Technical infrastructure model
The model at various levels – an example
Reasons why we need it
The role of ISO in the model
Standards and conformity assessment practices

3. Technical infrastructure model
Certification and claims of conformity
This is the process by which a person or company claims a good or service is in compliance with a standard or technical specification
1st party
2nd party
3rd party
After certification or a claim of conformity, at any level, marks of conformity can be issued to the product or service
Testing and inspection activities
Peer assessment and accreditation services
Backup level of check.
Often government or quasi-government bodies 
These bodies have formed regional and international organisations to ensure there is consistency on how peer assessment and accreditation is performed (IAF, ILAC and IEC Schemes)
Basis for MRAs
Regional bodies
Policy
Government Ministry or Department
Technical infrastructures affect:
manage risk;
be economically efficient;
incorporate ‘externalities’ and protect against market failure;
ensure the public's confidence in the economy; and
participate in the free trade of goods and service
WTO Agreements
Regional groupings
Metrology (measurement and physical standards)
Legal metrology
(weights and measures)
Scientific measurement (microbiological, chemical and non legal physical properties) -
Generally a mixture of government owned or private laboratories and research interests
International organisations (BIPM and OIML)
Regional bodies
Documentary standards
A range of organisations may develop documentary standards. In the ISO system each country has one national standards representative
In some sectors government Ministries or Departments make and define documentary standards
International standardisation bodies (ISO, IEC,
ITU,CODEX etc)
Regional bodies

4. Many levels to the technical infrastructure
IEC
ITU-T
CODEX
Agreement on
Technical Barriers to Trade
Australia
New Zealand
Regional
International
IQNet, IIOC
APLMF
Certification bodies
POLICY
METROLOGY
(PHYSICAL STANDARDS)
SCIENTIFIC LEGAL
DOCUMENTARY
STANDARDS
CERTIFICATION
AND CLAIMS OF
CONFORMITY
PEER ASSESSMENT
AND
ACCREDITATION
Regulators
Trading Standards Service
(Legal weights and measures)
Measurement
Standards
Laboratory
Certification bodies

5. The basics… why we need a technical infrastructure?
Internal reasons - Efficient and sustainable domestic economies
Economic development and poverty alleviation – technology transfer
Good regulatory practice (GRP) - OECD, APEC and the European ‘New Approach’ – from prescriptive to performance based laws
Level of government intervention and economic efficiency
Risk management
Address market failure – social, health and safety, environment
Allowing for innovation
Interoperability and interconnectivity – the knowledge economy

6. The basics… why we need a technical infrastructure?
External reasons - Trade – A nation’s competitive advantage
Economic efficiency through competition
International commitments – WTO - Notification
Globalisation and competitive advantage
Private sector requirements
Managerial, owner (shareholder) and consumer confidence
Contractual specifications
Marketing and brand differentiation

7. ISO and its structure ISO is a international technical NGO
140 countries, a mixture of government, semi-government and private bodies
Each national member body is to represent its government, industry and consumer views
Develops international policy and reflects this in international standards and guides
Recognition with related bodies include IEC, ITU and sector specific standardising bodies
Liaison with a number of international bodies
Its special because it produces both sector and horizontal standards and guides

8. ISO standardization in the model
Policy
Metrology (measurement and physical standards)
Documentary standards
Certification and claims of conformity
Accreditation
Peer Assessment
Over 200 technical committees in various sectors, over 2000 subcommitees and working groups
One of the international standardising bodies (IEC, ITU-T, CODEX etc)
Technical committees and standards development managed by individual ISO member bodies in accordance with the ISO/IEC Directives through consensus
Number of possible publications
ISO 9001:2000 one of its biggest standards
Increasing adoption and usage of international standards due to WTO agreements

9. ISO conformity assessment in the model
Policy
Metrology (measurement and physical standards)
Documentary standards
Certification and claims of conformity
Accreditation
Peer Assessment
Developing the technical requirements, including the publishing of a standard, is ½ the story
After that, mandatory or voluntary assessment of the product, system or service may be required, and sometimes a mark of conformity as well
This has the potential to either increase or decrease costs, or enhance or retard international trade
ISO/CASCO has developed international guides and standards on how to undertake this assessment function – i.e. assessment of conformity – conformity assessment
Conformity
assessment

10. Types of assessment of conformity
Declaration of conformity by 1st party
Suppliers declaration of conformity (SDoC)
CASCO future standards and 17049
Assessment of conformity by 2nd party
Procurement chain contracts
Government purchasing
Assessment of conformity by 3rd party
Product certification
Management systems certification
Mandatory or voluntary conformity assessment

11. Specific CASCO documents
Current document
New document
Group
Date
1st
Party
ISO/IEC Guide 22:1996
General criteria for supplier’s declaration of conformity
ISO/IEC and 17049
WG 24
SDoC
Aug
2004
2nd Party
No specific documents
3rd Party
ISO/IEC Guide 23:1982
Methods for indicating conformity with standards for third-party certification systems
Systematic review
2003
ISO/IEC Guide 28:1982
General rules for a model third-party certification system for products
ISO/IEC
Guide 28
WG14
Apr 2005
ISO/IEC Guide 53:1998
An approach to the utilization of a supplier's quality system in third party product certification
Guide 53
Adhoc Group on Guide 53
May 2004

12. Specific CASCO documents (2)
3rd Party
ISO/IEC Guide 65:1996
General requirements for bodies operating product certification systems
ISO/IEC Guide 62:1998
General requirements for bodies operating assessment and certification/registration of quality systems
ISO/IEC 17021
General requirements for bodies operating assessment and certification of management systems
WG 21
Management systems
2005
ISO/IEC Guide 66:1999
General requirements for bodies operating assessment and certification/registration of environmental management systems (EMS)
ISO/IEC Guide 67
Fundamentals of product certification
WG 14
Product certification
April 2005
ISO/IEC 17024
General requirements for bodies operating certification of persons
WG 17
Personnel certification
July 2003

13. Supporting processes
Regardless of what type of assessment of conformity is being employed there are some fundamental process steps
Current document
New document
Group
Date
Testing
Methods of test stipulated by TCs
ISO/IEC 17025:1999
General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025:1999 AMD1
WG 25
Jun 2004
Inspection
ISO/IEC 17020:1998
General criteria for the operation of various types of bodies performing inspection
Auditing
ISO/IEC 19011:2002
Guidelines for quality and/or environmental management systems auditing

14. Accreditation and Peer Assessment
Current document
New document
Group
Date
Accreditation
ISO/IEC Guide 53:1993
Calibration and testing laboratory accreditation systems -- General requirements for operation and recognition
ISO/IEC 17011
General requirements for bodies providing assessment and accreditation of conformity assessment bodies
WG 18
Feb
2004
ISO/IEC Guide 21:1996
General requirements for assessment and accreditation of certification/registration bodies
ISO/IEC TR 17010:1998
General requirements for bodies providing accreditation of inspection bodies
Peer Assessment
ISO/IEC Guide 43:1997
Parts 1 and 2, Proficiency testing by interlaboratory comparisons
ISO/IEC 17040
General requirements for peer assessment of conformity assessment bodies
WG 19
Dec 2004

15. Marks of conformity assessment
CASCO WG 12 is developing ISO/IEC Third party marks of conformity and their use
Products cannot carry systems related compliance marks
Systematic review will take place of ISO/IEC Guide 27:1983 Guidelines for corrective action to be taken by a certification body in the event of misuse of its mark of conformity in 2003
Implications for the discussion of labelling at the WTO TBT

16. Mutual recognition arrangements
Management System / Product/Personnel/ laboratories and tests
CERTIFICATION BODIES
ISO/IEC Guides and Standards
ISO/IEC Guide 68 MRAs – Dec 2002
DESIGNATES
ACCREDITS
CERTIFIES
ACCREDITATION BODY B
ACCREDITATION BODY A
CONFIDENCE
VOLUNTARY MUTUAL RECOGNITION
REGULATOR
G2G MUTUAL RECOGNITION

17. USAid presentation, Bishkek, Kyrgyzstan
Further information on conformity assessment can be found at the following link:
or Graeme Drake, Head of Conformity Assessment
and Secretary of ISO/CASCO at
The international technical infrastructure - Graeme Drake, ISO