International Organization for
Standardization (ISO)
SEVAL 2010
Berne
10 September 2010
Sean Mac Curtain
ISO Head of Conformity Assessment
CASCO Secretary
Outline
 Introduction and megatrends
 ISO System
 ISO’s international network
 Some key principles
 Types of standards
 A world in turmoil
 Emerging areas
 Topical standards areas
 Examples of standards in key issues
 Conformity assessment
 ISO Award
Introduction: - A World in turmoil and new paradigms

Volatile financial markets and
economies in recession / fragile
recovery?

Aspiration for sustainable development.
Inter-related issues of climate change,
energy, food and water

UN Millenium Goals and developing
countries

Converging technologies

Speed to market and new ways of
getting information

World trade and who leads ?
Who benefits from standards
 States and communities – Economic competitivity and
access to world markets, regulation, sustainable
development, loyal competition, public purchases…
 Companies – Technology transfer, market knowledge,
good management practices, quality recognition…
 Consumers – Products and services comparison, quality
improvement, information on performance, security and
impact on environment
 Researchers – Measurements, risk assessment,
dissemination of innovation, not re-inventing the wheel!
Standards help business thrive
 Impact internal business quality
culture and product reliability give competitive edge
 Help business adopt sustainable
development practices (e.g.
environmental management,
social responsibility, life cycle
assessment for products, energy
efficiency and management, etc.)
 Assists efficient resource
allocation (e.g. government
procurement, public works,
services, etc.)
 Bridge the knowledge gap and
enhance innovation
The ISO system - Governance
6
The ISO System
163 national members
98% of world GNI
97% of world population
1 038 standards
Collection of 18 083
ISO Standards
195 active TCs
3 238 technical
bodies
50 000 experts
As of 3 June 2010
• IT tools
• Standards
development
procedures
• Consensus
building
• Dissemination
produced in 2009
Central
Secretariat
in Geneva
153 FTE staff
Extent of ISO System
18083
ISO Standards
153 full-time posts
Secretary
Chairman
737 Secretariats
held by
39 countries
About 210 TCs
(195 active)
Ch
519 SCs
Convenor
C
3769 active projects at 2009-12-31
2 443 WGs
Standards generation

ISO Standard

A normative document, developed according to consensus
procedures, which has been approved by the ISO membership
and P-members of the responsible committee in accordance with
Part 1 of the ISO/IEC Directives as a draft International Standard
and/or as a final draft International Standard and which has been
published by the ISO Central Secretariat

ISO/PAS Publicly available specification

A normative document representing the consensus within a
working group.

ISO/TS Technical specification

A normative document representing the technical consensus
within an ISO committee

ISO/TR Technical report

An informative document containing information of a different
kind from that normally published in a normative document.

International Workshop Agreement (IWA)

An IWA is an ISO document produced through workshop
meeting(s) and not through the technical committee process.

ISO Guide

Guides provide guidance to technical committees for the
preparation of standards, often on broad fields or topics
The World Standards Cooperation (WSC)
The leading international standards organizations
Multi-discipline and cross
sector
For electrotechnology
For telecommunications
Collaborate to meet the challenges of converging
10
technologies
ISO’s international network
 WTO : TBT, SPS and GATS (services) agreements
 UN and UN agencies: CODEX, ILO, IMO, ITC, UNECE, UNEP,
UNGC, UNIDO, WHO, etc
 591 liaisons with international organizations
in technical work
 Links with six regional bodies (ACCSQ, AIDMO, ARSO, CEN,
COPANT, EASC) and PASC
 Economic actors: Accreditation: IAF and ILAC, Consumers
International, ICC, IFAN, World Economic Forum, etc…
Formal International Standardization
Some key principles
 Transparency *
 Openness *
 Consensus and impartiality *
 Market relevance and effectiveness *
 Coherence *
 Development dimension *
 Stakeholder engagement
 Due process
 National implementation/adoption

* explicit principles for the “development of international standards, guides and
recommendations with relation to articles 2, 5 and Annex 3 of the WTO/TBT agreement”
Different types of ISO International Standards

Terms and definitions

Graphical symbols, pictograms and labeling

Measurement, analysis and test methods

Interoperability requirements

Processing, validation and exchange of data

Performance characteristics for safety, security, health,
environmental requirements

Organizational and management practices

Packaging and labeling

Conformity assessment
Topical standards areas in ISO
 Oil and gas
 Industrial engineering
 Automobile
 Ships and marine
technology
 Food and nutrition
 Healthcare
 Building and
construction
 Security
 Climate change
 Consumer protection and information
 Energy efficiency
 Services
 Water
 Social responsibility
 Finance
 Sustainability
 Biotechnology
 Quality management
 Information technologies
 Conformity assessment
Examples of standardization in key sectors
The oil and gas industry


ISO/TC 67 - Materials, equipment and offshore structures for the
petroleum, petrochemical and natural gas industries
–
Products and component
specification and interoperability
–
164 IS and 60 in progress
–
Involvement of and adoption by
CEN and
American Petroleum Institute
ISO/TS 29001: application of
ISO 9001 for suppliers of the
oil and gas industry
Examples of standardization in key sectors
Automobiles
 ISO/TC 22 on motor vehicles
‒ Collaboration with regulators:
WP.29 of UNECE
‒ Testing for safety, noise and
environmental impact
‒ Ergonomics and graphical symbols
 Quality management:
ISO 16949 and the IATF
 Road traffic safety management:ISO/TC 241
 Intelligent Transport Systems : ISO/TC 204
 Battery Technology
 Natural gas fuelling stations for vehicles:
PC 252
Example of standardization on key issues
Responding to climate change

Environmental management:
the ISO 14000 series

ISO 14064/65: Greenhouse gas (GHG)
quantification, verification, validation - ‘GHG
Protocol’ and ‘Voluntary Carbon Standard’
real-life implementations

Others in ISO 14000 series on environmental
management, lifecycle assessment, labelling
…

“Carbon Footprint” investigations underway

FAO/WMO with ISO/TC 211 to help track
‘essential climate variables’

ISO at Bali UNFCCC, at COP 15 in
Copenhagen

Expanding cooperation with UNEP
Example of standardization on key issues
Energy

Over 20 ISO Technical Committees
involved in aspects of energy
efficiency and renewables

ISO SAG on Energy efficiency
and renewable sources
(SAG-E)

Joint ISO/IEC PC on international terminology for energy efficiency and
renewable energy sources

Significant progress on energy management systems (ISO 50001, ISO/PC 242)

Industrial energy efficiency (SAG-E recommendation)

Increase of efficiency and emission reduction of road vehicles (ISO/TC 22,
partnership with UNECE WP 29 and ITF)

Sustainability in construction and energy efficiency of buildings

New committees on biofuels including sustainability of biofuels

Cooperation with IEA, WEC, IEC, ITF and UNIDO
Updated Sept. 2009
Example of standardization on key issues
The water challenge
 ISO/TC 30 – important work on “water
metering” in closed conduits in close
collaboraton with CEN and OIML
 ISO/TC 113, Hydrometry: open channels &
groundwater: assessment of water resources
possible only by its proper measurement
 ISO/TC 147, Water quality – 245 published
standards: sampling and measurement of
physical, (bio-)chemical, (micro-)biological
water characteristics
 ISO/TC 224, Water treatment and drinking
water – quality of services – providing
confidence in areas of public/private transition
 NWIP on «Treated wastewater
reuse implementation» accepted
Updated Sept. 2009
Example of standardization on key issues
Food, agriculture and nutrition

ISO/TC 34, Food products
•
756 standards
• Food safety (ISO 22000 series)
• Detection of GMOs
• Food traceability systems
• Good manufacturing practices
• Quality management systems for crop production
• Irradiation of food
• Microbiological examination methods
• Many test methods for seeds, fruits and
vegetables, cereals, milk, meat and poultry,
spices, coffee, tea ..
 ISO/TC 93 on starch – established test methods
 ISO/TC 234 on fishery and aquaculture – ensuring sound ‘farmed fish’
production

Relations with WHO/FAO (Codex Alimentarius ), OECD, UN-ECE + WTO/SPS +
Retailers + Consumers
Example of standardization on key issues
Security
 Supply chain: ISO 28000 series
 Societal security: ISO/TC 223
 Information security: ISO 27000
 Biometrics
Example of standardization on key issues
Information and Communication Technologies
 Information security:
the ISO/IEC 27000 series
 Quality of IT services:
the ISO/IEC 20000 series
 Enabling e-business and supporting
financial services
 IT in buildings: building control
systems design
Example of standardization on key issues
Health and safety

Standards provides for an invaluable
resource supporting public health
and safety policies and
infrastructures

Safety requirements are addressd
by a large variety of products
standards

A large number of ISO standards
covers the healthcare sector: e.g.:
‒
Clinical evaluation and testing of
medical devices
‒
Clinical laboratories
‒
Health informatics and
interoperability
‒
Quality management in health
services
Example of standardization on key sectors
Services

Financial services : ISO/TC 68

Tourism : ISO/TC 228

Water services : ISO/TC 224

Education and training : ISO/TC 232

COPOLCO Guide on services
to consumers
Example of standardization on key issues
Consumer information and protection

Safety, quality, comparability of consumer
products and domestic appliances

Integrity of claims and informative labelling
(quality, safety, environment, ethical trade,
and others)

COPOLCO as catalyst for new policy and
standardization areas:
‒ Social
responsibility
‒ Needs of vulnerable populations: elderly,
persons with disabilities, children
‒ Product recall
‒ Customer service (codes of conduct,
complaints handling, dispute resolution)
Example of standardization on key issues
Quality Management

Over 1 million ISO 9001:2000
certificates in 179 countries (in
2009)

Sector implementations of
ISO 9000: automobile, aeronautics,
telecoms, railways, medical
devices…

Market surveillance of certification
to ISO management system
standards
Conformity assessment

Conformity assessment means checking whether products,
services, materials, processes, systems and personnel
measure up to the requirements of standards, regulations or
other specifications.

Conformity assessment benefits manufacturers, service
providers, users, consumers and regulators. It facilitates
international trade and supports sustainable development.

ISO and IEC jointly develop International Standards and
Guides through the ISO Committee on conformity assessment
(CASCO), these documents are referred to as the ‘CASCO
toolbox’.
ISO/CASCO:
The ISO Committee for Conformity Assessment


 The CASCO Toolbox consists of
111 ISO members are
27 documents (IS and Guides)
represented in CASCO, of which
covering:
69 are participating members and
42 observers
‒ Vocabulary, principles and
17 international organizations are
liaison members of CASCO:
BIPM, CAC, CEOC, EOQ,
Eurolab, IAF, IFAN, IFIA, IIOC,
ILAC, INLAC, IPC, IQNet, ITU-T,
OIML, UNFCCC and UILI
common elements of conformity
assessment
‒ Code of good practice
‒ Product, system, and persons
certification
‒ Testing, calibration, inspection,
marks of conformity
‒ Supplier’s declaration of
conformity, accreditation, peer
assessment, and mutual
recognition arrangements
The 1-1-1 Dream
1
Standard
1
Test
Accepted
everywhere
1
Conformity
Assessment
The Conformity Assessment processes
Test done by:
Object
+
Requirements
1st party
(the manufacturer,
service provider)
2nd party
(the purchaser,
the client)
3rd party - independent
(certification body, laboratory,
inspection body...)
Attestation type
SDoC
(Self Declaration
of Conformity)
Contract
Certificate
3rd party bodies can be accredited.
Accreditation bodies are assessed by their pairs
Example of risk based conformity assessment
High risk
(pacemaker, radiotherapy machine…)
Initial test of first
batch of nails
Production
Test
Done by the
manufacturer
Specifications
to be met
No full ISO 9001
system needed
Production
Testing of nails when a
change occurs
(equipment or design)
No accreditation required
Who does the certification
Very low risk, or no risk
Amount of surveillance
Manufacturer of medical devices
Degree of QMS
Manufacturer of nails
Specified
by the
client /
regulator
The quality
of the
production
is
continually
assessed
Accreditation required
Topical issues related to conformity assessment

Product (incl. service and process)
certification (ISO/IEC 17065) +
fundamentals of product
certification (ISO/IEC 17067)

Requirements on inspection bodies
(ISO/IEC 17020)

Certification of persons
(ISO/IEC 17024)

ISO’s neutrality policy

Qualification of assessors (AB) /
auditors specific requirements (CB)

Manual on conformity assessment
and market surveillance
ISO Award on Higher Education in Standardization
THANK YOU !
Sean Mac Curtain
maccurtain@iso.org
www.iso.org