ISO Focus

The Magazine of the International Organization for Standardization

Volume 1, No. 2, February 2004, ISSN 1729-8709

The Confidence
Business
UNIDO Director-General
charts the course ahead
Reliability for contraceptives
 Contents
1 Comment Mario Wittner, ISO/CASCO Chair
Looking outwards
2 World Scene
Highlights of events from around the world
3 ISO Scene
Highlights of news and developments from ISO members
4 Guest View
Carlos Magariños, Director-General, UNIDO
7 Main Focus
ISO Focus is published 11 times
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Editor : Giles Allen The Confidence Business
Contributing Editor : Elizabeth • What is accreditation?
Gasiorowski-Denis • The role of the International Accreditation Forum
Artwork : Pascal Krieger and • The role of the International Laboratory Accreditation
Pierre Granier
ISO Update : Dominique Chevaux • Cooperation
• The life of a peer assessor
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ISO Central Secretariat
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• Fundamentals of product certification
Telephone + 41 22 749 03 36
Fax + 41 22 749 09 47 • Trusting in a Supplier’s Declaration of Conformity
E-mail sales@iso.org • Certification in developing countries
• Fishing for Quality nets profits in Uganda
© ISO, 2004. All rights reserved. 30 Developments and Initiatives
The contents of ISO Focus are copyright • Mechanical contraceptives are far from static
and may not, whether in whole or in
part, be reproduced, stored in a retrieval • The Kids’ ISO 14000 Programme
system or transmitted in any form or
by any means, electronic, mechanical, 35 New this month
photocopying or otherwise, without • Lighting fires without burning down the house
written permission of the Editor.
• Freight container seals to combat terrorism
• ISO 9001:2000 guidelines for the education sector
ISSN 1729-8709
Printed in Switzerland 37 Coming up
Cover photo : ISO Highlights of upcoming articles
ISO Focus February 2004
Comment
Looking outwards
T
he ISO Committee for conformity
assessment (CASCO) has a dual
function : developing Guides and
International Standards and simultane-
ously playing a “ policy ” role. Last
year, the Chairman’s Advisory Group
agreed on a new structure for CASCO,
giving more visibility to its policy role.
This restructuring concerns both internal
policies – where the group, together with
the CASCO Secretariat, is responsible
for the surveillance and respect by the
working groups of the policy laid down
at CASCO plenaries – as well as the
external policy of ISO for conformity
assessment.
“ Inclusiveness
represents a key
element in ISO’s strategy :
we are doing
our best to include all
interested stakeholders
in our work.”
This external policy involves the
relationship with other technical entities
as well as with the different stakeholders :
regulators, consumers, and industry. And
CASCO is the ISO focal point for this.
We have now begun to meas-
ure the impact of our committee’s work
through surveys on the adoption and use
of our Guides and International Stand-
ards. The results have encouraged us
to move forward : many countries have
adopted them as national standards;
more, they are using them for regula-
tory purposes, for accreditation, as a
basis of mutual recognition agreements
and arrangements and in sector initia-
tives. The Asia-Pacific Economic Coop-
eration survey, for instance, shows that
13 countries of the area have adopted
ISO Guides and International Standards,
while the Pan American Standards Com-
mission demonstrates similar results.
The same goes for member countries
in European Committee for Standardi-
zation. To take the case of a sector ini-
tiative, we could cite the example of
EUREP-GAP, a certification system
for fresh fruits and vegetables, where
accreditation and recognition are carried
out on the basis of the ISO/IEC Guide on
general requirements for bodies operat-
ing product certification systems.
Recent presentations of our
work on mutual recognition agree-
ments and on general vocabulary relat-
ing to conformity assessment given to
the WTO/TBT (Technical Barriers to
Trade) committee shows the interest in
our documents abroad within the regu-
latory community.
Inclusiveness represents a key
element in ISO’s strategy : CASCO is
doing its best to include all the interest-
ed stakeholders in its working groups.
This effort begins right at grass roots
level with keeping the national “ mirror
committees ” in the loop, and continues
through at all levels of the work, with,
for instance, “ liaison ” members, spe-
cifically within our ISO committees on
the environment and on quality (TC 176
and TC 207).
“ Inclusiveness ” in the sense of
including developing countries in con-
formity assessment work was always a
goal of the committee’s past Chairman,
John Donaldson. New efforts have been
made in this direction, including the
recent re-establishment of a joint work-
ing group made up from members from
our committee and from those of the
ISO committee for developing country
matters. This idea was relaunched in the
course of a joint workshop between the
two committees on certification in 2003.
In view of the success of this latter
event, Mr. Alan Bryden, ISO Secretary-
General, announced a possible repeat of
the workshop in different regions in the
world. Selected working groups may
also in future hold meetings in those
developing countries with strong par-
ticipation in CASCO.
ILAC (International Laboratory
Accreditation Cooperation) and IAF
(International Accreditation Forum)
representatives are participating as con-
venors or members in all CASCO
working groups – a most happy devel-
opment, and I would like to pay particu-
lar tribute to this cooperation. The joint
ILAC-IAF-CASCO working group has
produced a number of important com-
munications on such matters as the dif-
ference between accreditation and certi-
fication of laboratories, as well as con-
firming recently the end of certification
to ISO 9000 based on the 1994 stan-
dards. Moreover, this trilateral coopera-
tion between the three international
bodies engaged in conformity assess-
ment is to be upgraded through a formal
agreement due to be signed this year.
Finally, a confirmation of the
importance ISO gives to conformity
assessment : one specific question was
included in the recent strategy consul-
tation ISO Horizon 2010, dealing with
the expectations of the standards com-
munity as to ISO’s role in conformity
assessment.
A stronger committee on con-
formity assessment will contribute to
developing the desired role that emerges
from the consultation.
Mario Wittner,
Chair of the ISO Committee
for conformity assessment
ISO Focus February 2004 1
World Scene
World Standards Day
2004
ISO, the IEC (International
Electrotechnical Commission)
and ITU (International
Telecommunication Union)
have announced “ Standards
connect the world ” as the theme
for this year’s World Standards
Day.
World Standards Day 2004
will celebrate the role played
by standards in connecting the
world, from providing the tech-
nological and scientific bases
underpinning health, safety and
environmental legislation to the
worldwide compatibility of
technology. Standards make an
enormous contribution to most
aspects of our lives, and this
year’s World Standards Day is
designed to raise awareness to
the extent of this contribution
and its importance.
Each year on 14 October, the
members of ISO, the IEC and
ITU celebrate World Standards
Day, which is a means of pay-
ing tribute to the collaborative
efforts of the thousands of
experts worldwide who develop
the voluntary technical agree-
ments that are published as
international standards.
ISO members commemorate
World Standards Day by organ-
izing special gatherings and
events, ranging from confer-
ences, exhibitions, and seminars
to film shows, TV and radio
interviews, and full “ standards
weeks ” around the date.
Road safety
The World Health Organization
(WHO) has announced that
World Health Day 2004 will be
dedicated to “ Road safety ” to
be commemorated on 7 April.
The day will be a unique
opportunity to increase aware-
ness about and action around
preventing road traffic injuries,
which claims the lives of 1,2
million people each year.
Because of the enormous social
and economic costs associated
with road traffic injuries, they
are a major global public health
and development concern.
2 ISO Focus February 2004
World Health Day 2004, with
the motto “ Road Safety is No
Accident ”, could become the
starting point for additional road
safety initiatives.
ISO technical committee ISO/
TC 22, Road vehicles, develops
International Standards for the
world automobile industry –
among them, child restraint sys-
tems, antilock breaking systems
(ABS) and airbags – that help to
prevent road crashes and ensure
road safety.
For more information :
www.who.int/world-health-day
/2004/en/.
Technical barriers
to trade
The Third Triennial Review of
the World Trade Organization’s
Technical Barriers to Trade
(WTO TBT) Agreement, which
Cheese-making
The fourth International Dairy
Federation (IDF) Symposium
on Cheese will be held in
Prague, Czech Republic, from
21 to 25 March 2004. This
symposium will explore
challenges and opportunities
in the fields of cheese ripening,
microbiology, characterization,
flavour formation and tech-
nology.
Twelve sessions will deal in
detail with a wide range of
scientific and technological
aspects of cheese and cheese
making. The object is to
exchange information, ideas and
strives to ensure that regula-
experiences between people in
tions, standards, testing and
research and people in practical
certification procedures do not
cheese making from many
create unnecessary obstacles to
countries. Symposium and
commerce, has recently been
registration details are available
concluded.
at www.conference.cz/IDF/
Recommendations were adopted
in relation to : the implementa-
tion and administration of the
agreement ; the promotion of
good regulatory practices ; the
transparency of procedures for
developing technical regula-
tions through better access to
information and improvement in
notifications ; the exchange of
experience in certification and
accreditation activities ; and the
optimization of technical assist-
ance to developing countries.
The Committee encouraged
WTO members to promote the
development of standards by
standardizing bodies having
accepted the Code of Good
Practice for the preparation,
adoption and application of
standards. Concerns were
expressed in relation to label-
ling.
In the course of this review,
ISO highlighted its contribution
to the aims of the TBT agree-
ment. In view of the subject
matter under review, the rele-
vance of the CASCO “ toolbox ” ISO technical committee ISO/
for conformity assessment and TC 34, Food products, subcom-
the ISO action plan for develop- mittee SC 5, Milk and milk
ing countries were particularly products, cooperates with IDF
emphasized. in developing International
Standards for the world dairy
For more information : industry. The close cooperation
www.wto.org between ISO and IDF extends
to joint publications bearing the
logos of both organizations.
ISO Scene
Consumers want to know
more about standards
and legislation
ISO’s Committee on consumer
policy (COPOLCO) is bringing
together government and busi-
ness experts as well as consum-
ers to explore the theme of
“ Self-regulation – Who’s at risk?
Standards and legislation, part-
ners in consumer protection ”,
at its workshop on 14 May
2004 in Prague, Czech Republic.
The balance between what is
regulated, what is partly or
co-regulated and what is self-
regulated is changing in many
countries. Speakers and partici-
pants will examine how volun-
tary standards interact with
regulatory regimes to ensure
that products and services meet
consumers’ expectations for
safety, performance, fitness for
purpose, pricing, redress and
other criteria.
International Standards are
becoming increasingly relevant
and useful in a “ global vil-
lage ”, as they provide a level
of consensus that transcends
national borders. They can
therefore credibly support
national policy goals and be
relevant in the different markets.
This workshop aims to explore
the validity of these concepts ;
e-commerce and environmental
protection are two subjects that
will receive particular atten-
tion. Participants will also
address specific examples of
alternative mechanisms such as
on-line alternative dispute res-
olution systems and standards
that underpin them, in the hope
of deriving particular recom-
mendations about best practices
for customer satisfaction.
The workshop is open to the
public. It will be followed by
a training session and the
COPOLCO plenary on 17 and
18 May.
For more information :
copolcoworkshop@iso.org
Award of excellence
Dr. Christian Favre, the former
Secretary-General of ISO, and
Mr. Gerhard Senk, the former
Secretary of Ausschuss
Normenpraxis in DIN (the
German standards users body),
were recently presented with
the Georges Garel Award for
their exceptional service to the
international community of
standards users.
In presenting this year’s award
to Dr. Favre, Neil Reeve,
President of IFAN, the
International Federation of
Standards Users, recognized
his outstanding contribution in
the development of internation-
al standardization and to the
activities of IFAN. Gerhard
Senk was praised for his dedi-
cated and outstanding contribu-
tion to the activities of IFAN
and its national member in
Germany, Ausschuss Normen-
praxis im DIN. The ceremony
took place during the IFAN
Members’ Assembly, which
was held in Paris in October
2003.
Award winners Dr. Christian
Favre (left) and Mr. Gerhard
Senk (right) with IFAN
President, Neil Reeve (centre).
The Georges Garel Award was
instituted by IFAN in Paris in
1979 in commemoration of its
first president, Georges Garel.
To date, only 12 people, from
France, Germany, Holland,
Sweden, Switzerland, United
Kingdom and USA, have
received the award.
For more information :
www.ifan.org
Supply chain security
Supply chain security demands
global solutions, and ISO tech-
nical committee ISO/TC 8,
Ships and marine technology,
is at the forefront of improving
security and increasing produc-
tivity of the freight container
transportation system.
Against this background, dele-
gates of ISO/TC 8 met in the
Republic of Panama, where an
opening session was high-
lighted by remarks from her
Excellency, Mireya Moscoso,
President of the Republic of
Panama : “ In the country of
Panama, individuals from the
public and the private sectors
are working with dedication
and diligence, hand in hand
with prestigious world class
international organizations, in
transforming the maritime sec-
tor in Panama and the region
through education, training and
research…”
ISO/TC 8 meeting in
Panama, from left to right :
Jorge Arosemena, Executive
Director, City of Knowledge ;
Bertilda Garcia, Administrator,
Panama Maritime Authority ;
Capt. Charles Piersall, Chair
of ISO/TC 8 ; His Excellency
Jerry Salazar, Minister of
Canal Affairs.
The meeting brought together
major industry and government
stakeholders in an effort to
address security gaps as well as
propose solutions to those secu-
rity concerns through the devel-
opment of standards for the
international trade community.
Workshops for the establish-
ment of the International
Maritime University in Panama
(UMIP), strategic planning for
integral safety programme, and
sessions on maritime security,
environmental security and port
security were also held during
the week-long conference.
ISO/TC 8 is the “ linking
instrument ” between the
International Maritime
Organization (IMO), which
sets the requirements and regu-
lations, and the international
shipping and shipbuilding
industry.
Identifying audiovisual
works
The ISAN International
Agency, the organization
responsible for administering
the International Standard
Audiovisual Number (ISAN),
is now available online.
The Agency has been set up to
manage the voluntary number-
ing system for the identifica-
tion of audiovisual works, in
accordance with ISO 15706:
2002, Information and docu-
mentation - International
Standard Audiovisual Number
(ISAN). The standard provides
a unique, internationally recog-
nized and permanent reference
number for each audiovisual
work, from commercials to
newscasts to episodes of indi-
vidual television series. The
use of the code is expected to
assist in the allocation of roy-
alties, information retrieval and
anti-piracy purposes as well as
to help track the use of the
audiovisual work throughout
its life.
In accordance with ISO 15706,
the ISAN International Agency
has the responsibility for the
overall ISAN system mainte-
nance and administration. The
ISAN International Agency
appoints and oversees the work
of ISAN registration agencies
– established to serve specific
countries, group of countries or
specific sectors of the audio-
visual industry – which are
authorized to receive and proc-
ess applications for ISAN and
allocate the actual ISAN num-
bers to the audiovisual works.
For more information :
www.isan.org
ISO Focus February 2004 3
Guest View
Carlos Magariños
C
arlos Alfredo Magariños,
Argentinian, economist,
is the Director-General
of the United Nations Industrial
Development Organization
(UNIDO). He was first elected in
December 1997, making him, at only
35, the youngest person to ever head
a United Nations specialized agency.
In December 2001, he was re-elected
as Director-General for a further
period of four years.
Mr. Magariños’s experience in
industry and trade goes back well
before his entry into the international
arena. At the age of 31, he became
State Secretary for Industry and
Mining of Argentina during the first
UNIDO
term of President Carlos Menem.
Previously he occupied the position
of National Director for Foreign
Trade – awarded through public
competition – and Under-Secretary
of State for Industry.
In 1996 he became Economic and
Trade Representative of the Argentine
Government in Washington, D.C.,
with the rank of Ambassador and
State Secretary, where he remained
until elected Director-General
of UNIDO.
As Director General of UNIDO,
Carlos Magariños has received four
titles Honoris Causa.
ISO Focus: Mr. Magariños, what are
the main objectives you would like to
achieve during your second mandate
as Director-General of UNIDO ?
Carlos Magariños : To envision
UNIDO’s future, we have to glimpse
the recent past. Being now halfway
into my second mandate, I am pleased
to mention here some of our organiza-
tion’s main accomplishments.
At field level, the impact of our
programmes has grown considerably.
Technical cooperation delivery in 2003
reached USD 94 million, compared to
4 ISO Focus February 2004
USD 68 million in 2000, and we want
to consolidate this result.
The focus of our technical activi-
ties has been sharpened : our technical
cooperation for low-income countries
accounted for 70 % of our portfolio last
year, in comparison to only 48 % in
1996. In the past three years only, the
level of voluntary government funding
almost doubled, from USD 25 million
to USD 45 million, and we will strive
to maintain this course.
“ UNIDO has concrete
priorities aiming
at enhancing
the competitiveness
of developing countries.”
Yet there are still many challenges
lying ahead. To increase productiv-
ity in developing countries, we must
focus more on the promotion of the
private sector, of investments, of agro-
industrial development and on ensur-
ing improved market access and trade
capacity building. Equally important
are the management of technology,
dealing with environmental problems
and ensuring efficient energy and
water use. UNIDO has concrete medi-
um-term priorities aiming at enhanc-
ing the competitiveness of developing
countries, their potential to attract
investors and capability to overcome
market failures.
ISO Focus: As a specialized agency of
the United Nations, how do you ensure
that UNIDO is effectively coordinated
and known around the world ?
Carlos Magariños : UNIDO alone
cannot win the fight against poverty
and marginalization. Therefore, inter-
national cooperation and partnerships
will continue to be of strategic impor-
tance. We recently signed an agree-
ment with the WTO, as well as with
ISO. We are closely discussing with
your organization the launching of an
e-learning programme for standardiza-
tion. UNIDO will also participate in
UNCTAD XI 1).
We take part in most of the major
international fora (UN General Assem-
bly, ECOSOC, etc.) and initiatives
(such as the New Partnership for Afri-
ca’s Development, the Commission of
Human Society, the UN Development
Assistance Framework). UNIDO has
in fact a global forum function, as it
generates and disseminates industri-
al development knowledge and influ-
ences the development agenda by initi-
ating and conducting debates on these
matters.
ISO Focus: In addition to the almost
600 staff members at the UNIDO head-
quarters in Vienna, you have some 120
staff working in the field worldwide 2).
What sort of activities do they under-
take?
Carlos Magariños : Through its field
operations, UNIDO transforms its
member states’ financial support into
concrete development projects, into
practical reality. The organization’s
field offices establish and maintain
 (Left) UNIDO headquarters
(right-hand building) in
Vienna, Austria.
Chair making (Below)
Strengthening the micro,
small- and medium-
scale enterprises in
Peten, Guatemala.
The Centre provides
technical training and
assistance to small
entrepreneurs in market-
ing, quality improvement
of products and legal
aspects of business
development.
UNIDO

UNIDO Integrated Programme,

Guatemala

“Efforts have been made,

in cooperation with ISO
and IAF, to help
accreditation bodies in
developing countries
be recognized
internationally.”
institutional and political relations
with national counterparts and gov-
ernments, and maintain dialogue on
cooperation projects. They participate
in local UN-coordination activities
and programming mechanisms as
well, such as the Common Country
Assessment, the United Nations
Development Assistance Framework
and the Poverty Reduction Strategy
Paper. Our field offices also take part
in programme and project planning
UNIDO

subsequent to identifying and assess-

ing country needs. Working with
local donors to mobilize funding is
1) UNCTAD XI is the 11th General Conference
of the United Nations Conference on Trade and
Development, to take place in June 2004 in
Brazil, gathering around 3 000 participants from
190 countries.
2) UNIDO is represented in 35 countries
by 10 Regional Offices, 19 Country Offices
and 6 Focal Points. It also has 13 Investment
and Technology Promotion Offices (ITPOs),
five Investment Promotion Units (IPUs), 27
National Cleaner Production Centres (NCPCs),
established in cooperation with UNEP, and
10 International Technology Centres (ITCs),
that collaborate with the ITPOs.
another important function they per-
form. Finally, they manage, monitor
and support the implementation and
reporting processes of all our activi-
ties at local level.
UNIDO’s decentralization pro-
cess gradually shifts more emphasis
towards the field, and we have made
good progress in this direction. Conse-
quently, we will be able to better adapt
to the circumstances and conditions of
each region, to the benefit of our cli-
ents and partners.
ISO Focus: UNIDO’s contribution
to trade capacity building offers
assistance to selected enterprises that
want to implement ISO 9000, ISO
14000 and other ISO International
Standards. What have been the success
stories from such initiatives ?
Carlos Magariños : UNIDO has
been involved with standardiza-
tion and related matters since its
inception in 1962 as the Centre for
Industrial Development and most of
the standards bodies in developing
ISO Focus February 2004 5
UNIDO
countries have been set up by our
organization.
UNIDO itself has been assess-
ing how to implement ISO 9000 to
further improve its efficiency and
the effectiveness of its services, and
our member states are now becoming
strong supporters of this idea.
By offering assistance in imple-
menting ISO 9000 and ISO 14000, we
give greater opportunities to the devel-
oping world to be integrated in global
value chains. UNIDO also supported,
together with ISO, other actions such
as the surveys on trade implications
of ISO 9000, ISO 14000 and eco-
labels. To enable certified enterprises
in developing countries to be accepted
abroad, efforts have been made, in
cooperation with your organization
and the International Accreditation
Forum, to help accreditation bodies
in these countries to be recognized
internationally.
I would like to mention just a
few recent success stories. In Brazil,
we offered training and assistance
to companies in the textile and gar-
ment industry for obtaining ISO 9000
certification. In Bahrain, we created
institutional capacity at the Ministry
of Commerce to advise enterprises
on total quality management methods
6 ISO Focus February 2004
“ UNIDO and ISO can
jointly elaborate solutions
to problems
developing countries
face in accessing
international markets.”
and ISO 9000 standards. Within our
integrated programme in Sri Lanka,
we supported the launching of the ISO
14000 implementation.
ISO Focus: The UNIDO and ISO
partnership, as confirmed in a recent
Memorandum of Understanding 3),
aims to assist developing countries and
economies in transition to participate
effectively in world trade. What does
this involve in concrete terms ?
Carlos Magariños : Let me say first
how pleased I was by the participa-
tion of Mr. Alan Bryden at the Round
Table on Trade during our General
Conference in December. It was a con-
crete way in which UNIDO and ISO
can cooperate, namely to conceptual-
ize and jointly elaborate solutions to
the key problems these countries are
facing in accessing international mar-
kets. This was the first time a Secre-
Training Ugandan women in garment-
making at the Textile Development
Agency (TEXDA).
UNIDO Integrated Programme, Uganda
tary General of ISO attended a UNIDO
General Conference. Another concrete
example relates to technical assistance
for capacity building in standardiza-
tion and related areas, including con-
formity assessment and consumer
awareness. Along these lines, a partic-
ular emphasis should be given to train-
ing. However, we move away more
and more from the traditional approach
to the transfer of know-how. We need
to take advantage of the thriving tech-
nological advances, in particular in the
IT area, and develop tools and method-
ologies, such as e-learning. These will
increase our efficiency and outreach.
3) See ISO Focus, January 2004, page 2.
Main Focus
The Confidence
Business
n international trade, tax barriers
I
are coming down, but at the same
time technical barriers relating to
safety, health and the environment are
going up in many cases (witness the
recent regulations on bioterrorism).
Governments are increasingly being
required to act to improve consumer
protection. There is a manifest need
for a global growth in trust and con-
fidence – and these need to be built
up.
Conformity assessment activi-
ties are growing exponentially, day by
day, all over the world. Why ? Essen-
tially, because of a need for credibili-
ty, since conformity assessment is an
important way to increase credibility
and confidence in the trustworthiness
of goods and services, and thereby to
facilitate trade. Because of this, the
need for clear rules for conformity
assessment activities is increasing in
parallel with this growth.
What precisely is conformity
assessment ? It is the method of deter-
mining compliance with a standard or
regulation.
“ There is a need for
a global growth in trust
and confidence.”
Differing conformity assess-
ment procedures could impede the
exchange of goods and services, and
vigilance is required to ensure that
such procedures should be non-dis-
criminatory, transparent and avoid
unnecessary obstacles to trade.
There has been consider-
able progress towards greater accept-
ance of internationally harmonized
approaches to conformity assessment
through the wider application of ISO/
IEC standards and guides. A related
development has been the evolution
of accreditation-based international
and regional systems of conformity
assessment. These systems continue
to evolve, building confidence for
the users of conformity assessment,
including regulators, and promoting
global acceptance through peer assess-
ment. Similarly the expansion of pri-
vate conformity assessment schemes
and the increased acceptance of
Suppliers’ Declaration of Conformity
(SDoC) represent another dimension
in global standardization trends.
The operation and function-
ing of conformity assessment and
how ISO’s work fits into the global
development of the discipline are not
always well understood, so that Main
ISO Focus February 2004 7
Main Focus
Focus this month seeks first to bring
light to the fundamentals of what
accreditation and conformity assess-
ment consist of, and to stake out the
roles of two actors in the field, IAF and
ILAC, along with that of ISO. At the
same time, it brings together various
facets of ISO work in the conformity
assessment arena : it shows where and
how ISO’s committee on conformity
assessment (CASCO) is evolving to
become more transparent, coherent
and user-friendly, and some specific
and important themes that are being
worked on in the evolving context of
today, and how the notion of inclusive-
ness (see p. 1) is helping to channel
the actions and strategies of the major
actors worldwide towards ever greater
collaboration and coherence.
As an example of links being
forged : IFAN (International Federa-
tion of Standards Users) that is hold-
ing its next assembly in parallel with
the upcoming CASCO plenary (in
Amsterdam), will be represented at
that meeting – an ideal opportunity for
CASCO to hear the voice of industry,
and for IFAN, in turn, to learn of the
developments and needs in conformity
assessment.
By bringing all the actors and
stakeholders closer and encouraging
interaction in the work activities, the
trust in conformity assessment pro-
cesses will grow and the discipline
will progressively become more trans-
parent and clearer globally.
8 ISO Focus February 2004
What is
accreditation ?
By Mr. Hanspeter Ischi, SAS,
Berne, Switzerland
T
he word “ accreditation ” comes
from the Latin credere (to
believe, to be confident in) to
which the word dare, meaning to give
or to offer, is added. “ Accreditation ”
therefore means “ to give confidence ”.
People may be confident that accred-
ited bodies provide their services with
competence and reliability.
Processes are developing
tomorrow’s competence
Conformity assessment bod-
ies (laboratories, inspection and
certification bodies) continuously
developing their competence in a sys-
tematic way have a big advantage on
a more and more competitive market.
Accreditation recognizes the con-
stant declaration and development of
their competence and service quality.
Competence according to the spirit
of the relevant standards can only be
assured on a long-term basis if accred-
ited organizations – and the accredita-
tion bodies themselves – including all
their staff members go through a per-
manent and conscious process! So far,
accreditation should be seen as a struc-
ture to implement processes leading to
competence, quality and efficiency.
From detailed planning to complex
security checks, systematic processes
ensure cable-car passengers’ safety.
The task of an accredita-
tion service such as SAS, the Swiss
Accreditation Service, is to assess if
a conformity assessment body (CAB)
has the necessary technical compe-
tence and infrastructure to provide
reliable services. The CAB’s proce-
dures should be clearly structured and
controlled in a defined way. CABs
need a specialized know-how and to
develop an adapted structure in order
to allow systematic decisions and
learning processes.
“ In their daily lives,
consumers depend
on reliable analyses
and tests.”
To assess also means to pro-
vide feedback in relation to technical
knowledge, infrastructure and qual-
ity system. With this, accreditation
bodies support CABs in their proc-
esses to maintain and continuously
develop their competence through
competent assessments. Accreditation
will be successful and of big value if
accreditation bodies and their direct
customers are aware of such (learn-
ing) processes and are taking care of
them in a systematic way. As a result,
the European and worldwide economy,
governments and industry will develop
more and more trust in accredited bod-
ies, in their reports and certificates.

In the chain of production and services,
the user can have confidence that the
accredited testing and conformity testing
bodies provide their services in a
competent and reliable manner.
Having a look at how accredi-
tation works makes the significance
evident. Let us take cable transpor-
tation plants and operators as an
example :
• Accredited calibration laboratories
calibrate measuring equipment for
material testing.
• Accredited testing laboratories
test mechanical, hydraulic and
electronic system components and
assess their quality.
• Accredited inspection bodies
inspect final approval of cable
transportation.
• Accredited certification bodies for
products certify security compo-
nents of cable transportation. In
delivering credible conformity
certificates they recognize com-
pliance of such components with
security requirements.
• Accredited certification bodies
evaluate quality and environmen-
tal management systems of cable
transportation manufacturers and
operators.
• Accredited certification bodies for
personnel examine training and
technical competence of special-
ists.
In the entire chain of produc-
tion and services, one must and may
have confidence that accredited testing
and conformity assessment bodies pro-
vide their services in a competent and
reliable manner.
National and international
recognition of competence
Accreditation has an important
function within the present economic
life environment. It creates the con-
dition for international recognition
of testing reports and conform-
ity certificates through the European
Cooperation for Accreditation (EA),
the International Laboratory Accredi-
tation Cooperation (ILAC) and the
International Accreditation Forum
(IAF). These organizations make big
efforts to hamonize assessment prac-
tice worldwide and have established
recognition agreements among their
members which include thorough
evaluation of the accreditation bodies’
own competence through these interna-
tional organizations. Accreditation can
therefore be seen as an international
system recognizing that a conformity
assessment body is competent to carry
out a specific activity with high reli-
ability and in conformance with the
quality required.
“ Consumers and industry
depend on the compliance
of products according
to defined requirements.”
An accreditation service such
as the Swiss Accreditation Service
(SAS) evaluates and assesses the tech-
nical competence and service quality
of calibration and testing laboratories
as well as of inspection and certifica-
tion bodies. This assessment is based
on ISO/IEC standards, developed by
the ISO Committee for conformity
assessment (CASCO), and standards of
the CEN/CENELEC (European Com-
mittee for Standardization/European
Committee for Electrotechnical Stand-
ardization). Accreditation contributes
in an important way to the recogni-
tion and competitivity of these bodies
on globalized markets. The following
examples illustrate the important tasks
fulfilled by accredited bodies :
• Measuring instruments of manu-
facturers and service providers
have to be calibrated in order
to allow correct measurements.
Accredited calibration labora-
tories execute this task with the
required precision and traceabil-
ity to the International System of
Units (ISO 31).
ISO Focus February 2004 9
Main Focus
• In their daily lives, consumers
depend on reliable analyses and
tests, e.g. in the fields of food
products, electrotechnical appli-
ances and medical diagnostical
analyses. Accredited testing
laboratories make theses analyses
and tests in a reliable manner.
From the right concrete mixture to
starting the construction work, reliable
tests and controls are vital to be sure
of bypassing all obstacles.
• Inspections have to be carried out
in order to detect safety “ gaps ” in
food products, medicine and techni-
cal installations in time. Accredited
inspection bodies fulfill these tasks
with high reliability.
• Consumers and industry depend
on the compliance of products
with defined requirements.
Accredited certification bodies
for products attest this conform-
ity, after evaluation, in a credible
way.
• Accredited certification bod-
ies for quality systems deliver
conformity certificates attesting
the conformity of quality systems
with the standard requirements.
This allows clients to be confident
that these firms have structures
and working procedures at their
disposal ensuring a service which
respects the deadlines and corre-
sponds to the agreed quality.
10 ISO Focus February 2004
• Accredited certification bodies
for environmental management
systems attest with their conform-
ity certificates that firms present
the necessary conditions in order
to continuously improve its envi-
ronmental performance.
• A large number of firms depend
on recognized
specialists whose
competence has
to comply with
defined criteria.
Amongst these
specialists we
find welders,
auditors, business
consultants and
project managers.
Accredited certi-
fication bodies
for personnel
attest their tech-
nical competence
so that the econo-
my can rely on
these specialists.
Confidence due
to transparency and
comparability
Accreditation attests the com-
petence of a laboratory, an inspection
or a certification body to provide
defined services in a professional, reli-
able and efficient way. Accreditation
develops confidence in the services
of accredited bodies. It creates, on the
national and the international level,
transparency and comparability in the
market place.
A country like Switzerland has
a fast-increasing number of accredited
bodies in more and more technical
fields at its disposal, namely individual
firms and departments of major com-
panies, but also associations, federal
offices, cantonal offices, universities
and research institutes. The clients
of accredited bodies are of the same
diversity: the economy and the authori-
ties use its services, as do science and
research.
In the legally regulated field,
testing and conformity assessments
cause products and services to comply
with the requirements, safety to be war-
ranted and therefore consumers to be
protected. Accredited testing and con-
formity assessment bodies test in a reli-
able manner whether products and serv-
ices comply with legal requirements.
In the legally non-regulated
field, products and services are put on
the market on the basis of public law
contracts. It is the responsibility of the
contract partners to determine which
requirements make up the content of
the contract and, if need be, which
have to be fulfilled by the quality
system of the manufacturer or serv-
ice provider. Accredited conformity
assessment bodies play a central role
in the evaluation of complex products
and modern quality systems.
About the author
Hanspeter Ischi
tarted work in
978 as a chemi-
al engineer in
he agrochemical
ndustry in
Basel, Switzer-
and, in the field
evelopment of
n-site field
echniques to
nalyse pesti-
cides on plants. In 1984, he became head
of a chemical quality control laboratory
in the Swiss defense industry, with his
main task to implement modern tech-
niques in liquid and gas chromatography ;
he was responsible for quality assurance
of propellants. In 1986, as a consequence,
a quality management system according to
military standards was established. As
soon as ISO 9001 appeared, this manage-
ment system was adapted to it. The Swiss
federal propellant plant was one of the
first companies to be certified against ISO
9001. Since 1991, he has been responsible
for the implementation of the accreditation
system in Switzerland and head of the
Swiss Accreditation Service (SAS).
Member of the EA and ILAC Executive
Committee and head of the EA laboratory
committee.
 !
The role
of the
International
Accreditation
Forum
By Mr. John Owen, Corporate
Secretary, International
Accreditation Forum Inc.
(IAF), World Association for
Conformity Assessment

T
he International Accreditation
Forum (IAF) is the world asso-
ciation of conformity assessment
accreditation bodies and other bodies
interested in conformity assessment
in the fields of management systems,
products, services, personnel and other
similar programmes of conformity
assessment. Its primary function is
to develop a single worldwide pro-
gramme of conformity assessment
which reduces risk for business and
its customers by assuring them that
accredited certificates may be relied
upon. Accreditation assures users of
the competence and impartiality of the
body which has been accredited. IAF
members accredit certification or reg-
istration bodies that issue certificates
attesting that an organization’s man-
agement, products or personnel com-
ply with a specified standard (called
conformity assessment).
The primary purpose of IAF
is two-fold. Firstly, to ensure that its
accreditation body members only
accredit bodies that are competent to
do the work they undertake and are panies with an accredited conformity IAF Programmes
not subject to conflicts of interest. assessment certificate in one part of
The second purpose of the IAF is to the world, to have that certificate rec- IAF currently has programmes
establish the Multilateral Recognition ognized elsewhere in the world. The in place to :
Arrangement (MLA) between its objective of the MLA is that it will
accreditation body members which cover all accreditation bodies in all • Develop guidance, rules and proce-
dures for the operation of accredi-
reduces risk to business and its cus- countries in the world, thus eliminat-
tation, certification/registration and
tomers by ensuring that an accredited ing the need for suppliers of products
the enhancement of mutual recog-
certificate may be relied upon any- or services to be certified in each
nition.
where in the world. IAF works to find country where they sell their products
the most effective way of achieving
a single system that will allow com-
or services. Certified once – accepted • Ensure that all IAF accreditation
everywhere. body members operate to the high-
ISO Focus February 2004 11
Main Focus
est standards of competence and
integrity, and only accredit bodies
that have demonstrated that they
are competent and impartial.
• Harmonize accreditation proce-
dures and their implementation
based on international standards
and guides, and IAF guidance on
their application.
tries operate to the same standard as
those in their own country. There is
now a total of 32 IAF Members who
are signatories to the IAF MLA. IAF
is encouraging more of its members
to join the MLA, as soon as they have
passed a rigorous evaluation process,
to ensure that their accreditation pro-
grammes are of world standard.
The overall aim is to reduce
risk to the buyer, owner, user or con-
sumer of the item being inspected. The
general requirements for the operation
of various types of inspection body
are given in the joint International
Standard ISO/IEC 17020, General cri-
teria for the operation of various types
of bodies performing inspection.

• Develop guidance, rules and pro-

cedures for the operation of sector
conformity assessment schemes to
meet the needs of specific indus-
tries and compliance programmes
to satisfy regulatory or government
requirements.
• Exchange information between
accreditation bodies.
• Cooperate in the training of asses-
sors and other personnel.
• Contribute to the work of ISO and
other relevant international bodies.
• Assist emerging accreditation bod-
ies in low- and medium-income
economies.
• Liaise with regional groups of
accreditation bodies and with other
relevant bodies such as ILAC, ISO
and industry groups.
“ A single worldwide
programme of conformity About the author
assessment reduces
John Owen is
risk for business and he Corporate
ecretary of the
its customers.” nternational
Accreditation
Forum (IAF) and
Accreditations granted by IAF
was formerly
Multilateral Recognition Arrangement
(MLA) accreditation body members
Director for
ystems, Man-
are recognized worldwide based on gement and
their equivalent accreditation pro- Business with
grammes, therefore reducing costs tandards
and adding value to industry and
consumers. Certificates in the fields
Australia International (SAI). He was
the ISO/TC 176/SC 2 Deputy Project
of management systems, products, Leader for the revisions of ISO 9001 and
services, personnel and other similar ISO 9004, Co-convener of the joint ISO/
programmes of conformity assess- TC 176-ISO/TC 207 Task Group dealing
with the harmonization of ISO 9001 and
ment issued by bodies accredited by
ISO 14001 as well as the Convener of the
IAF MLA members are therefore
ISO/TC 176/SC 2 Task Group which
relied upon in international trade. prepared both editions of the ISO 9001
Without International Standards, Small Business Handbook.
technical barriers to trade would
result in increased costs for importers E-mail secretary@accreditationforum.com
and consumers, reduced competition Web www.iaf.nu
and different standards of a product
or service.

What is the IAF MLA ?
The primary objective of con-
formity assessment is to give its users
confidence that requirements applica-
ble to products, services, systems, pro-
cesses and materials have been met.
One purpose of the IAF MLA
(Multilateral Recognition Arrange-
ment) is to provide users in countries
with accreditation bodies, that are IAF
MLA members, assurance that equiva-
lent certification bodies in other coun-
12 ISO Focus February 2004
Why do inspections ?
With the growth of world trade
and increasing trade liberalization,
as well as the rapid development of
new manufacturing and distribution
technologies, has come hundreds of
third-party national and multinational
inspection bodies.
These organizations examine
a huge range of products, materials,
installations, plants, processes, work
procedures and services, in the private
as well as the public sector, and report
on such parameters as quality, fitness
for use and continuing safety in opera-
tion.
From ISO 7010:2003.
The role
of the
International
Laboratory
Accreditation
Cooperation
By Mr. Alan Squirrell, Secretary
ILAC (International Laboratory
Accreditation Cooperation)

L
aboratory Accreditation provides a
means of determining the compe-
tence of laboratories to perform
specific types of testing, measurement
and calibration. It enables people who
want a product, material or instrument
to be tested or calibrated to find a reli-
able testing or calibration service able
to meet their needs. It also allows a
laboratory to determine whether it is
performing its work to appropriate
standards (including the test methods
and related quality assurance proto-
cols) and that their laboratory staff
have the appropriate skills.
Laboratory accreditation pro-
vides a formal recognition of com-
petent laboratories, thus providing a
ready means for customers to access
reliable testing and calibration services
and have confidence that the measure-
ments being carried out are fit for their
intended use.
Adoption of this International taken the assessment and accreditation
Standard has helped countries adopt of the other partner’s laboratories.
How does laboratory a uniform approach to determining The aim of the ILAC Arrange-
accreditation assist laboratory competence, thus allow- ment is to develop a global network of
international trade? ing countries with similar accredita- accredited testing and calibration labo-
tion systems to establish agreements ratories that can be relied on to provide
Many countries around the between themselves, based on mutual accurate results. This Arrangement
world have one or more organizations evaluation and acceptance of each oth- came into effect on 31 January 2001,
responsible for the accreditation of er’s accreditation systems. and provides technical underpinning
their country’s laboratories. Most of Such international agreements, to international trade by promoting
these accreditation bodies have now usually called Mutual Recognition cross-border stakeholder confidence
adopted the International Standard, Arrangements (MRA), are crucial and acceptance of accredited labora-
ISO/IEC 17025, General requirements in enabling test data to be accepted tory data.
for the competence of testing and between countries. In effect, each part- This system of mutual recog-
calibration laboratories, as the basis ner in such an arrangement recognizes nition between accreditation bodies
Passive
the other partner’s Fire Systems
accredited laborato- has enabled accredited laboratories to
for the accreditation of their country’s
testing and calibration laboratories. ries as if they themselves had under- achieve a form of international recog-
ISO Focus February 2004 13
Main Focus
nition, and allowed test data accom-
panying exported goods to be more
readily accepted on other markets.
This effectively reduces costs for both
the manufacturer and the importers,
as it reduces or eliminates the need
for products to be retested in another
country. It is also consistent with the
World Trade Organization’s (WTO)
objectives to minimize technical bar-
riers to trade.
Countries without viable accre-
ditation systems can also seek to have
their laboratories accredited by estab-
lished accreditation bodies in other
countries, so that their test data and
associated goods can be accepted on
foreign markets. These countries can
also endeavour to develop their own
accreditation system based on the
structure and experience of these sys-
tems in other countries.
What ILAC does
As of December 2003, 45
laboratory accreditation bodies of
ILAC (from 36 different countries)
have signed the multi-lateral, mutual
recognition arrangement to promote
the acceptance of accredited test
and calibration data. The key to the
Arrangement is the development of a
global network of accredited testing
and calibration laboratories that are
assessed (against ISO/IEC 17025,
General requirements for the com-
petence of testing and calibration
laboratories, and relevant sector-spe-
cific requirements) and recognized as
being competent by ILAC Arrange-
ment signatory accreditation bodies.
The signatories have, in turn, been
evaluated by peers (against ISO/IEC
Guide 58, Calibration and testing lab-
oratory accreditation systems – Gen-
eral requirements for operation and
recognition, and ILAC requirements)
and shown to meet ILAC’s criteria
for competence. Now that the ILAC
Arrangement is in place, governments
can take advantage of it to further
develop or enhance trade agreements.
The ultimate aim is increased use and
acceptance by industry as well as gov-
ernment of the results from accredited
14 ISO Focus February 2004
laboratories, including results from
laboratories in other countries. In this
way, the free-trade goal of “ a product
tested once and accepted everywhere ”
can be realized. For this process
to work, there must be meaningful
involvement with ILAC’s stakehold-
ers (e.g., labs, regulators) and ILAC
strives to make this happen.
ILAC also provides advice and
assistance to countries that are in the
process of developing their own labo-
ratory accreditation systems. These
countries can participate in ILAC as
associate or affiliate members, and
access the resources of ILAC’s more
established members. ILAC works
with ISO and other organizations to
provide a holistic approach in metrol-
ogy, accreditation and standardization
– all-important in the development of
appropriate infrastructure for develop-
ing countries.
“ ILAC provides assistance
to countries that are
in the process
of developing their own
laboratory accreditation
systems.”
In conjunction with ILAC, spe-
cific regions have also established
their own accreditation cooperations,
notably in Europe (EA) and the Asia-
Pacific (APLAC) who themselves
have (ILAC recognized) Mutual Rec-
ognition Arrangements, and also in the
Americas (IAAC) and Southern Afri-
ca (SADCA). These regional cooper-
ations are members of – and work in
harmony with – ILAC and are repre-
sented on ILAC’s Executive Commit-
tee. ILAC is encouraging, and assist-
ing in, the development of similar
regional cooperations in other parts of
the globe.
Hence ILAC is the world’s
principal international forum for the
development of laboratory accredita-
tion practices and procedures, the pro-
motion of laboratory accreditation as a
trade facilitation tool (and for domestic
improvement), the assistance of devel-
oping accreditation systems, and the
recognition of competent test facilities
around the globe.
For more information, please
contact ILAC on :
E-mail ilac@nata. asn.au or
Web site www.ilac.org
About the author
Alan Squirrell
as a BSc (Hons)
n Applied
Chemistry, and a
Certificate of
Education
Post-graduate).
He joined NATA,
Australia’s
ational labora-
ory accredita-
tion authority,
in March 1981, and has held the position
of ILAC Secretary since 1 January 2001.
During his time at NATA, Mr. Squirrell
has held the positions of Manager Chemi-
cal Testing, Manager Proficiency Testing
and Technical Consultant. Alan Squirrell
has been involved in international activity
associated with ILAC, APLAC, EA,
CITAC (and CCQM) and ISO, particularly
in relation to technical matters associated
with linking accreditation to metrology
(eg traceability, measurement uncertainty,
proficiency testing, etc), for a number of
years. He is also a past Chair of CITAC
(Co-Operation on International
Traceability in Analytical Chemistry)
and the APLAC (Asia Pacific Laboratory
Accreditation Cooperation) Proficiency
Testing Committee.
The life of a
peer assessor
By Ms. Joan Brough-Kerrebyn,
Manager Quality Management
System, SCC (Canada)
eer evaluation 1) is a job you

P will never hear about in the

career section of the popular
press. While it is a discrete and spe-
cialized function, it is also one with
a far-reaching impact on international
efforts to promote global trade with the
implementation of conformity assess-
ment services. Peer evaluators from
accreditation bodies around the world
implement a peer evaluation process
that enables the worldwide recognition
of registration and certification certifi-
cates. The work is very exacting with
knowledge and experience require-
ments that make the 50 or so people
who do it a close-knit group. We know
each other fairly well, not from meet-
ing in familiar surroundings, but rather
in foreign locations as we form teams
that visit and evaluate another econo-
mies’ accreditation body (AB).
In reality, being part of a peer
evaluation team is long hard work,
performed in a strange environment
icates they issue accepted by buyers in tory accreditation systems – General
under time and performance stresses,
non-domestic markets. Accreditation requirements for operation and recog-
while still recovering from jetlag.
bodies contribute staff to carry out nition, as well as communicating with
What is accomplished, however, is
these evaluations as part of their the applicant AB to clarify information
very important to the AB being visited.
commitment to support international and finalize the logistics of the visit.
The team’s findings will influence the
multilateral recognition arrangements The Sunday meeting, chaired by the
future design and delivery of the AB’s
(MRA). It is these arrangements that team leader, is intended to bring all
services. The resulting evaluation
provide the foundation for recognition the team members up to speed on their
report will provide the evidence that
of certificates by the members of these roles and, to explore initial impres-
global associations of ABs, such as the
international associations. sions of the organization being evalu-
IAF and ILAC can have confidence in
A typical evaluation visit ated. Formal introductions are initiated
the services of the AB. Without this
begins with a Sunday evening meet- at an opening meeting held Monday.
formal acknowledgement, the AB
ing following the arrival of the two to On average, a week is spent at the
clients – the registration/certification
five team members from their separate AB. Two days are used to evaluate
bodies or laboratories the AB has
corners of the world. Before this meet- the office operations and procedures.
accredited – cannot obtain the global
ing there has already been a week or The rest of the week is used to actu-
acceptance they seek to have the certif-
so of work expended, on reviewing ally witness the AB assessing a client
documents against requirements such in order to observe the performance of
1) Based on the article “ Have Checklist Must as ISO/IEC on General requirements their assessors and the implementation
Travel ” published in CONSENSUS Magazine, for assessment and accreditation of their assessment procedures. In
Volume 30 Number 1 (Special Edition Autumn
2003) ; with permission from the Standards of certification/registration bodies between these activities, the evaluation
Council of Canada (www.scc.ca). and Calibration and testing labora- team meets frequently, usually in the
ISO Focus February 2004 15
Main Focus
evening back at the hotel, to compare
notes and to ensure that all the require-
ments are covered. By mid-week the
team leader starts putting together a
written report incorporating input from
the team into a document that outlines
what findings the AB should address,
as well as its key strengths and weak-
nesses. The visit ends with a closing
team meeting to discuss the report and
ensure that the issues are well under-
stood and agreed upon.
The evaluation team’s work,
however, does not end upon their
departure from the AB. The AB is
required to respond and address the
evaluation findings in order to improve
their programme operations and be in
conformance with the requirements.
The team then reviews the AB’s
response to ensure that the issues have
been adequately addressed and in a
few cases a member of the evaluation
team may be required to revisit the AB
to confirm implementation and effec-
tiveness. Add to this the administrative
and approval process for the MRA,
and you are looking at 6 to 10 months
before the recognition becomes real-
ity.
These procedures are relatively
straightforward but in practice no two
evaluations are identical. The whole
experience is an exciting exercise in
diplomatic adaptation and quick think-
ing.
“ An exciting exercise
in diplomatic adaptation
and quick thinking.”
While the evaluation process
involves established international
requirements, no two ABs implement
them in an identical manner. The key
is to evaluate the “ equivalence ” of
the results and to avoid comparing
what the AB does directly with what
happens in your own office. Every AB
operates in a different market and cul-
ture and this affects how they imple-
ment the requirements. For example,
in some cultures the practice of formal
voting is not something embraced with
comfort by committee members as
16 ISO Focus February 2004
they prefer to seek informal consen- About the author
sus. A requirement for documented
voting procedures is problematic to Engaged in
them and, even if written, is rarely onformity
ssessment
used or avoided. What is also often
nitiatives for
noticeable is the ratio of resources
ver 20 years.
employed, where labour is relatively Ms. Joan
less expensive, more human resources Brough-
are used, while an AB in high labour Kerrebyn
cost regions will depend more on M.Sc., MBA,
systems aided by technology. Both oined SCC
approaches have their advantages and Standards
pitfalls. Experienced team members Council of
understand that they must always be Canada) nine years ago with eleven years
open-minded to the implementation prior experience in the delivery and man-
agement of conformity assessment services.
of the requirements, focusing on the
end results not the means of achieving As the Manager of the corporate-wide
them. In return for their efforts, evalu- Quality Management System for the SCC,
ation team members broaden their per- her position involves providing coordi-
nation and advisory services to SCC
spective on how to accomplish certain
management at the corporate level in
AB functions and usually return home
addition to advising on specific
with a few good ideas. programme issues related to international
It’s the exposure to each other’s criteria.
systems and the opportunity to evalu-
Prior to her present position she was
ate against the agreed-upon require-
responsible for the day-to-day operations
ments that cements the process of of the SCC national accreditation pro-
mutual recognition. By developing a gramme for quality system registrars.
sense of familiarity and sharing ideas, She also has extensive experience as a
each AB gains comfort with each other peer evaluator for the International
and expands the knowledge they need Accreditation Forum (IAF) and the PAC
to maintain their programmes. What (Pacific Accreditation Cooperative).
the evaluation team members also In addition to contributing to various
often gain from their hard work is a international peer evaluation teams,
very positive, if not brief, experience she has delivered numerous international
with a different culture that develops workshops and seminars on accreditation
and certification.
mutual respect and understanding at
the personal level.
Although the AB staff may be
nervous, they are also eager to have
your opinions on how they operate. If
the evaluation team does their job cor-
rectly the AB is more relaxed by the
week’s end and thankful to be directed
to those areas where there may be
opportunities for improvement. While
the team members have the advantage
of viewing the operations as outsiders,
everyone gets their turn on the other
side of the table – being evaluated by
their peers. There is a sense of commu-
nity amongst ABs, with a mutual goal
of ensuring that the global accredita-
tion system maintains its integrity and
is well respected.

Reaching for
impartiality
By Mr. Randy Dougherty and
Mr. Alister Dalrymple,
Co-convenors of ISO/IEC 17021
I
SO’s Committee on conformity
assessment (CASCO) formed work-
ing group (WG) 21 on management
system certification – co-convened by
one convenor (Randy Dougherty)
from the USA and the other (Alister
Dalrymple) from France – to devel-
op a standard designated ISO/IEC
17021, Conformity assessment – Gen-
eral requirements for bodies providing
assessment and certification of man-
agement system. The co-convenors
here freely survey the development
and highlights of an important new
draft International Standard.
Alister Dalrymple : Randy, how would
you define in a nutshell the scope of the
future ISO/IEC 17021 standard ?
Randy Dougherty : Setting out
requirements for management systems
certification bodies.
Alister : What’s new in the require-
ments placed on certification bodies ?
Randy : I would say that the key issues
concern :
• The requirements for impartiality ;
• The new approach for management
of competence of personnel ;
• The use of the functional approach
in stating the requirements for the
three types of audits (initial, sur-
veillance, and re-assessment) in a
certification cycle ;
• Extending the expectation of a
two-stage audit (as used for Envi-
ronmental Management System
– EMS – audits) to Quality Man-
agement System (QMS) and any
future management systems audits ;
and
• Using ISO 9001:2000 for the inter-
nal QMS of a certification body.
Randy : Alister, what do you think are related to the body providing consul-
the advantages to the users, especially tancy services for the development or
industry ?
Alister : Firstly, this standard brings
implementation of its management
system. The new standard includes a
requirement that the certification body
together in a single document simi-
cannot certify such an organization for
lar or related requirements which
co-existed in different documents.
at least two years.
Also by incorporating International
Accreditation Forum Guidance, it Alister : Can you give us some more
should reduce the need for future IAF detail on the new “ Principles ” section
guidance. Thirdly, it provides a frame- of the document ?
work for future certification operations Randy : This section explains that the
with other management systems. All “ value of third-party certification is
this is compatible with orientations public trust achieved through gaining
observed today in business, where the confidence ” of a number of diverse
there is a tendency towards an inte- parties that rely upon certification.
grated approach to complementary The section includes six principles
management systems. that inspire confidence: impartiality,
competence, responsibility, openness,
Alister : What were the new ideas that confidentiality, and complaint han-
have been worked on ? dling. These principles are intended
to be the basis for the subsequent
Randy : The first committee draft
specific performance and descriptive
included some new concepts. One of
requirements. Stated in another way,
the most controversial of these was
the intent is that ISO/IEC 17021 will
for a management systems certifica-
be a standard with principles-based
tion body to apply to its own opera-
requirements.
tions a quality management system
that conforms
to ISO 9001:
2000. Anoth-
er one con-
cerns an orga-
nization that
had received
certification
from a body
ISO Focus February 2004 17
Main Focus
Randy : There are a number of con-
troversial topics in that list, such as
impartiality …
Alister : The requirements for impar-
tiality are considered to be one of the
more significant aspects of the new
standard. This is a high priority issue
for the working group because of
increasing questions about the impar-
tiality, objectivity and independence
of management systems certification.
The working group is committed to
developing requirements that will con-
tribute to increased confidence in the
impartiality of management systems
certification.
Impartiality is one of the prin-
ciples for third-party certification.
In addition to stating the principle,
there is a description of four threats to
impartiality. The subsequent require-
ments for impartiality are intended to
be for the elimination or minimization
of these four threats. The document
encompasses most of what was pre-
viously in ISO/IEC Guide 62:1996,
General requirements for bodies oper-
ating assessment and certification/
registration of quality systems and ISO/
IEC Guide 66:1999, General require-
ments for bodies operating assessment
and certification/registration of envi-
ronmental management systems, and
related IAF Guidance on the subject.
This represented something of a chal-
lenge to achieve considering that there
are about 25 clauses related to impar-
tiality in the IAF Guidance.
The requirements for impar-
tiality start with the commitment of
the top management of a certification
body. Requirements related to impar-
tiality include internal and external
personnel, including auditors. And
there is a focus on one of the perceived
major threats to impartiality, which
is to prevent the self-review threat
posed by any relationships between
the certification body and any indi-
vidual or organization that provided
management systems consultancy to
an organization.
18 ISO Focus February 2004
Alister : Randy, perhaps you’d like to
say a few words on the ways proposed
to counter-balance these threats to
impartiality … ?
Randy : Sure ! The certification
body will be required to conduct and
document an analysis of threats to
impartiality, which is to include those
posed by the activities of related bod-
ies, and then demonstrate how it will
manage the threats. This analysis and
management strategy is required to
be reviewed by a committee formed
by the certification specifically to
safeguard impartiality. It should be
noted that the second committee draft
includes an informative annex to assist
users to better understand what is
involved in conducting an impartiality
analysis.
“ The certification body
will be required to conduct
and document an analysis
of threats to impartiality.”
Alister : And what about that other
controversial issue, the links between
certification and consulting ?
Randy : One of the new requirements
is that a certification body does not
certify a client for at least two years
after any related body provided man-
agement systems consultancy. This is
to address what is perceived to be one
major self-review threat to impartiality,
which is consultancy and certification
for the same organization by closely
related bodies. However, in order to
not prohibit acceptable activities, it
has been necessary to very carefully
define what is a “ related body ” and
“ consultancy ”.
One reasonable question is :
why two years? A two-year separation
has proven to be successful in pre-
venting real and perceived conflict of
interest for auditors, and has also been
successful for preventing perceived
conflict of interest between certifica-
tion bodies and related consultancy
organizations, by several industries :
QS 9000 for the automotive industry,
and AS 9100 for the aerospace indus-
try. TL 9000 for the telecommunica-
tions industry, and RC 14000 for the
chemical industry also include such a
prohibition – for even longer periods !
Alister : What would you call as the
other key issues in ISO/IEC 17021 ?
Randy : Another significant aspect
of the new standard is the approach
for management of competence of
personnel. Most of this has been
developed from IAF Guidance, and
has been incorporated into the cur-
rent draft of ISO/IEC 17021. In brief,
the new concept is for a certification
body to establish robust processes for
competence assessment and contract
review, then use the outputs of these
two processes to assign an audit team
that has the right set of skills needed to
audit a specific organization. Also, the
certification body’s client needs to be
informed of these decisions.
Randy : Third-party certification has
evolved a lot in recent years, and
we’ve seen the introduction of many
new standards and techniques. Alister,
how do you see this movement reflect-
ed in ISO/IEC 17021 ?
Alister : Updated audit technology has
been incorporated into the standard.
Whereas ISO/IEC Guides 62 and 66
had extensive requirements for the
initial audit, and also a requirement for
surveillance and re-assessment, it had
almost no requirements for the process.
A functional approach was used for
drafting of the audit process require-
ments. The benefit is that there are
specific requirements for the selection,
planning, conduct, review, and subse-
quent certification decision, for each
of the three types of audits in a normal
certification cycle : initial certification
audit, annual surveillance audit, and
the third-year re-certification audit.
The new standard also requires
a two-stage audit process for the
initial audit. This process was a new
concept introduced for environmental
management system (EMS) audits.
With the change of ISO 9001: 2000
to the process approach, there is wide
support among standards and confor-
mity assessment systems stakeholders
of the value of the two-stage audit for
ISO 9001:2000. Assuming that the
process approach will be used for any
future management systems standard,
this approach has been incorporated
into ISO/IEC 17021. For ease of users
of the standard, the detailed require-
ments for the two different stages are
documented in annexes.
Alister : One final significant require-
ment is requiring the use of ISO 9001:
2000 for the internal QMS of a cer-
tification body. Where did this come
from ?
Randy : Historically, ISO/IEC Guides
62 and 66 have required certifica-
tion bodies to have a quality system.
Considering that ISO 9001: 2000 is the
most globally accepted standard for a
QMS, it is reasonable and appropri-
ate that ISO 9001: 2000 requirements
apply to the QMS for a certification
body. This requirement has wide
support among management systems
accreditation and certification bodies.
This is only to be expected, since these
organizations promote certification
of conformance to ISO 9001:2000 as
applicable to all organizations.
Randy : And what stage are we at
now ?
Alister : The draft was circulated
in October 2003 for a second con-
sultation and vote on approving the
document to be a Draft International
Standard (DIS). This comment period
closed on 16 January 2004. We’re now
planning our next meeting to examine
the results of the voting and to consider
any further comments received.
Randy : What about the suggestions
for improvement at the first committee
draft stage ?
Alister : 473 comments were consid-
ered by the group in developing the
second committee draft. This led us to
revise somewhat our expectations and
WG 21 then committed to :
• Preferring principles-based perfor-
mance requirements to prescriptive
requirement wherever possible ;
• Incorporating the latest conformity
assessment technologies ; and
• Being consistent with other docu-
ments being developed by ISO/
CASCO.
Alister : Will ISO/IEC 17021 replace
the existing ISO/IEC Guides 62 and
66 ?
Randy : Yes, but it also has the
extended remit to apply to certification
bodies performing any type of man-
agement system certification.
Alister : Where does this leave us ?
Randy : In developing this standard,
we called upon a wealth of existing
experience in the quality and environ-
mental world, but we also have the
challenge of trying to anticipate the
About the authors
Randy A.
Dougherty is the
irector of regis-
rar accreditation
or the Registrar
Accreditation
Board in
Milwaukee, WI,
USA. RAB is the
perational part-
er of the ANSI-
RAB National Accreditation Program, the
US accreditation body for ISO 9000 qual-
ity management systems (QMS) and ISO
14000 environmental management
systems (EMS) registrars.
Mr. Dougherty oversees the activities of a
staff of 5 and 25 contract auditors. He has
25 years of experience in third-party con-
formity assessment. He was the president
and CEO of NSF-ISR, Ltd, a QMS and
EMS registrar, from 1996 to 2000, and
was employed by NSF International, an
ANSI-accredited standards development
organization and third-party product
certifier, from 1975 to 1996.
Randy Dougherty holds a master’s degree
in public health administration from the
University of Michigan in Ann Arbor, and
earned his bachelor’s degree from Lake
Superior State College.
needs of certification for other forms
of management systems. However,
the experts participating in Working
Group 21 are all conscious of the
challenge and are committed to try-
ing to enhance the Certification of
Management Systems. There’s still a
lot of work to be done, but thanks to
the collective effort all concerned and
the excellent groundwork laid down
by the past convenor of WG 21, Lars
Waldner from Sweden, we can look
forward with a certain optimism to the
future ISO/IEC 17021.
Alister
Dalrymple
has been living
and working in
France for 30
years.
For the last
10 years, he
has occupied
the post of
International
Strategic Affairs Manager for the
AFAQ Group, a major European Third
Party Certification body, and is also
International Director and Member of
the Executive Board of AFAQ-ASCERT
International. Since 1995, he has been
one of the principal French Delegates to
ISO Technical Committee 176, and was
appointed co-convenor of the ISO/TC
176/TC 207 Joint Working Group for the
revision of the standards on the Audit of
Quality and Environmental Management
Systems (ISO 19011:2002). Presently co-
convenor of ISO CASCO Working Group
21 in charge of developing ISO 17021,
he also sits on several other CASCO
committees. Alister Dalrymple originally
graduated as a Civil Engineer and holds
a post-graduate degree in Educational
Sciences.
ISO Focus February 2004 19
 Main Focus
© Underwriters Laboratories Inc.
The bases
of product
certification
By Mr. Jim Beyreis,
Vice-President of Engineering,
Underwriters Laboratories
Inc., and convenor of
CASCO Working Group 14,
Fundamentals of product
certification
“ The certification of conformity
to standards is regarded by many
countries, and in respect of many
products, as a valuable supplement
to the buyer/seller relationship.
Moreover, it can be an important
factor in enabling developing
countries to secure access to
foreign markets.”
20 ISO Focus February 2004
W
hen these words appeared
in the Foreword of the 1980
ISO publication, Certifica-
tion Principles and Practice, ISO and
IEC had each been producing myriad
technical standards having interna-
tional consensus for many decades.
Yet, the same Foreword noted that
there was a “ shortage of documenta-
tion on the subject of certification,”
even though third-party product cer-
tification had been well established
in many countries and regions of the
world for the better part of a century.
Without the means to put International
Standards to work though internation-
ally acceptable certification practices,
many technical standards would be of
limited value.
Recognizing the need for guid-
ance on the means to carry out con-
formity assessment, ISO declared its
intention to prepare guidelines on con-
formity assessment certification under
the auspices of (the then) CERTICO,
ISO’s specialized certification commit-
tee. In the years since, CERTICO, and
the successor conformity assessment
committee, CASCO, have continued
to develop and update a series of ISO/
IEC guides and standards for conform-
ity assessment to fulfill this commit-
ment. These were drafted to reflect
the organization and practices of vari-
ous existing certification bodies. The
certification mark of one such body,
Underwriters Laboratories Inc. (UL),
appears on nearly 20 billion products
entering commerce each year.
Organization
of a certification body
One of the earliest documents,
ISO/IEC Guide 28, Conformity assess-
ment – Guidance on a third-party cer-
tification system for products, provides
a rather specific description as to one
manner in which a certification body
may be organized and carry out its
work. It deals with contracting, and,
specific practices for the basic ele-
ments of certification, including sam- • System No. 5 – Type testing Certification and related activities
pling, testing, evaluation, surveillance, and assessment of factory quality provides additional description and
and responsibility for the certification control, audit of factory quality discussion for each of these eight sys-
decision. Guide 28 also includes control and testing of factory or tems. The certification body organiza-
several model forms for such matters market samples. tion and practices described by Guide
as the basic contract between the sup- • System No. 6 – Factory quality 28 is most like that of System No. 5.
plier and the certification body, model system assessment and its accept-
outlines for assessing a manufacturer’s ance only. The core elements of
quality system, model procedures for
selecting product samples, a model • System No. 7 – Batch testing. third-party certification
certificate of conformity and simi- • System No. 8 – 100 % testing. ISO/IEC Guide 67, Conformity
lar model documents which may be assessment – Fundamentals of prod-
required to carry out the various activi- uct certification, provides further
ties of a product certification body. “ General requirements for guidance on the core elements of
Guide 28 should be quite direct- certification bodies have third-party product certification.
ly useful as a guide for anyone wish- found great acceptance This guide, in particular, serves to
ing to organize a product certification make it clear that there are many
body. It should be clearly understood, and use worldwide.”
however, that bodies may provide
equally valid product certification pro-
grammes through other organizational
structures and practices. Certification
and related activities, published by
ISO and IEC in 1992, describes eight
different certification systems.
• System No. 1 – Type testing
© Underwriters Laboratories Inc.

only.
• System No. 2 – Type testing with
audit testing of market samples.
• System No. 3 – Type testing with
audit testing of factory samples.
• System No. 4 – Type testing with
audit testing of market and/or fac-
tory samples.

circumstances in which certification

is desired, that third-party involve-
ment in conformity assessment is of
interest, and that the structure of cer-
tification activities can legitimately
vary significantly, depending upon
various circumstances and objectives.
Guide 67 serves to illustrate the core
elements of product certification and
provides a degree of explanation
to foster an understanding of their
application in a certification system.
© Underwriters Laboratories Inc.

As further illustrated by Guide 67,

the elements of product certification
can be used together in various com-
binations, depending on the circum-
stances of a particular certification
programme, without prescribing any
single arrangement of the elements
or single form of practice for the
ISO Focus February 2004 21
Main Focus
individual elements. The core ele- resentative of the certification body Because Guide 65 may be
ments addressed by Guide 67 are : makes periodic visits to the factory to applied to certification bodies having
audit the quality system under which a variety of structures and operating
• Sampling
the product is manufactured. in various fields, it has found great
• Determination of characteristics acceptance and use around the globe.
The importance of useful
• Evaluation Guidance for judging
and informative documentation on
• Certification decision the suitability certification continues to grow for
of a certification body buyer/seller relationships as well as
• Licensing
for developing countries, as the market
• Surveillance Because there are many dif-
place becomes ever more global. The
ferent ways in which
need to provide support to develop-
the elements of certifi-
ing countries endeavouring to enter
cation may be arranged
world markets is evident. In devel-
and applied, there is a
oped countries and regions, certifica-
need, by those such as
tion bodies need support to respond
© Underwriters Laboratories Inc.

accreditation bodies, for

to suppliers and customers who are
guidance for judging
demanding greater cooperation among
the suitability or accept-
certification bodies. The conform-
ability of a certification
ity assessment guides published by
body. Guide 65, General
ISO will continue to respond to these
requirements for bodies
needs because they reflect long-stand-
operating product cer-
ing practices of global bodies, with
tification systems, fills
continuing improvement through the
this need. As stated by its
ongoing work of ISO/CASCO.
scope, Guide 65 “ speci-
fies general requirements
Ensuring ongoing that a third-party operating a certifica-
tion system shall meet if it is to be
surveillance
recognized as competent and reliable.” About the author
ISO/IEC Guide 53, An Guide 65 provides guidance for assess-
approach to the utilization of a suppli- ing whether such matters as general Jim Beyreis is
organization of the certification body Vice-President
ers quality system in third-party prod-
f Engineering
uct certification, deals with surveil- enterprise, impartiality and confidenti-
t Underwriters
lance, one specific element of certifi- ality fulfill the necessary requirements.
Laboratories
cation. Surveillance begins once con- It addresses various aspects of certifi- nc. He has been
formity to requirements has been ini- cation services, including contracting, ctive in ISO’s
tially determined and the certification the investigation and evaluation proc- Committee on
body makes the “ licensing ” decision, ess, and the certification decision. In onformity
and grants the manufacturer a certifi- general, Guide 65 serves as an outline ssessment
cate of compliance or authorization to as to the organization and practices of CASCO) for
apply a certification mark to the prod- a product certification body, without more than a decade, and is currently
uct. Through ongoing surveillance, prescribing just exactly how the certi- convenor of CASCO Working Group 14,
fication body is to be composed or how which has drafted new ISO/IEC Guide 67
the certification body acquires evi-
(publication expected in 2004), and has
dence that the certified product con- the certification body is to conduct its
prepared an updated ISO/IEC Guide 28
tinues to conform to requirements. In certification process.
(publication expected in 2004).
general, surveillance may be product-
based or may be process-based. In
© Underwriters Laboratories Inc.

product-based surveillance, samples

of the product may be obtained at the
factory or from the market place, and
examined against the requirements of
the standard applicable to the product,
or may be evaluated to determine that
they are identical to the sample orig-
inally evaluated. In process- or qual-
ity system-based surveillance, a rep-
22 ISO Focus February 2004
 test results and other supporting docu-
Trusting in mentation can be made available when
a Supplier’s authorized bodies request it.
Declaration Saving time and money
of Conformity Today, rapidly advancing tech-
nology and increased international
competition make it essential that sup-
By Mr. Joel Urman, Convenor, pliers have an opportunity to utilize all
available options to minimize product
WG 24, Supplier’s costs and ensure the time to bring a
Declaration of conformity product or a service to market is at a
and its supporting minimum. Conformity assessment is
documentation (USA) an important aspect in the development
of product, processes and services, but
method that is most responsive to spe-
cific regulatory, customer and market
requirements.
SDoC is a valid conformity
assessment way for a supplier to give
assurance that the object of conform-
ance meets specified requirements.
SDoC is a conformity assessment
approach that requires rigorous test-
ing and product evaluation. SDoC
eliminates time-consuming product
registration procedures that are often
part of technical regulations. SDoC
allows for an efficient, unimpeded,
cost-effective method of assessing
product conformance that ensures that

C
onfidence that products, proc- this assessment does add costs and the product meets specified require-
esses, services and systems time to the development cycle. ments.
conform to specified require-
ments is an essential part of world-
wide commerce. ISO, through its ISO
Committee for conformity assessment
(CASCO) develops standards and
guides to ensure that regulators, sup-
pliers and consumers have sufficient
confidence that an object of conform-
ance (product, process, service or
management system) meets specified
requirements.
Conformity assessment can be
C
SDo
performed and assured :
• by the first-party, the supplier him-
self,
• by the second-party, the user of the
object of conformance, or
• by a third-party, a person or organi-
zation specializing in testing and/or
certification, unrelated to the sup-
plier or his customer.

A supplier who attests that his

product, process, service or manage-
ment system conforms to specified
requirements, is utilizing Supplier’s
Declaration of Conformity (SDoC).
The supplier may conduct the testing
himself or contract with a third-party
to do the testing. The test results are
evaluated, and when all requirements
are met, the supplier issues a formal
statement that the product or service
is in conformance to the requirements.
A statement that the product meets
specific requirements can be included
in the product documentation, and the
A Supplier’s Declaration of
Conformity offers suppliers, cus- “ Suppliers have an
tomers and regulators a conformity opportunity to utilize all
assessment option that reduces costs available options to
and speeds the availability of new
products to customers. This does not minimize costs and ensure
preclude the use of third-party testing the time to bring a
and/or certification to demonstrate product to market is at
conformity to specified requirements.
Rather, a supplier should be permitted a minimum.”
to choose the conformity assessment
ISO Focus February 2004 23
Main Focus
The cost and time savings that
result from SDoC unquestionably ben-
efit suppliers of products, processes,
services and systems. SDoC also sig-
nificantly benefits their customers
and all those who use and need their
offerings. The cost savings that SDoC
gives the supplier result in reduced
costs for everyone involved, including
the end users. Clearly, lower product
cost resulting from SDoC are a major
benefit to the supplier, their customers,
and end users.
Customers and end-users also
benefit when new products, serv-
ices and systems are made available
as quickly as possible. By reducing
the time required to assess and certify
that a new product meets specificed
requirements, SDoC reduces the time
to make new products available to
their customers and end users access.
For example, in the US in response to
input from the information technology
industry the Federal Communications
Commission (FCC) moved to stream-
line their equipment approvals process
in 1999 to allow a variety of conform-
ity assessment options, including
SDoC, based on the perceived risk to
the public network. This has greatly
eased the burden of the FCC labs and
facilitated bringing cutting edge prod-
ucts to US consumers. Other interna-
tional telecommunications equipment
regulatory regimes have moved to a
similar streamlined approach, employ-
ing SDoC.
Consistent implementation
of suppliers’ declaration
of conformity
CASCO recognized the need
for consistent implementation of
SDoC many years ago, and developed
ISO/IEC Guide 22, General criteria
for supplier’s declaration of conformi-
ty, to meet that need. As SDoC became
increasingly used and accepted, Guide
22 became a widely used document.
Applicability of the original version of
Guide 22 was limited to manufactured
products.
In 1996, CASCO recognized
that SDoC had broader applicability.
24 ISO Focus February 2004
“ An important way for
suppliers to provide
assurance that an object
of conformity meets
specified requirements.”
WG 9 was formed, and Guide 22 was
revised to explicitly include processes
and services, in addition to products.
WG 9 also determined that Guide 22
covered conformity to management
system standards, such as ISO 9000.
Many people involved in con-
formity assessment felt that, for SDoC
to gain even greater acceptance, par-
ticularly with regulators, an SDoC that
conformed to the provisions in Guide
22 should be supplemented with addi-
tional information. In 2000, CASCO
initiated its regular five-year review of
Guide 22 at which time, early in 2001,
ANSI proposed a conversion of Guide
22:1996, General criteria for suppli-
er’s declaration of conformity, from a
guide to a ISO standard, and to develop
a new standard, that would specify
what supporting documentation a sup-
plier could provide the further increase
the confidence in their declaration.
Converting Guide 22 to an
ISO/IEC standard, designated ISO/
IEC 17050-1, Conformity assessment
– Supplier’s declaration of conform-
ity – Part 1, General requirements,
has three specific aims. They are to
increase SDoC’s :
1. value by making its requirements
clearer and “ normative ”, i.e. estab-
lishing a standard;
2. usability by making its provisions
more acceptable to government and
regulatory institutions;
3. understanding and clarity for sup-
pliers and users.
This International Standard is
to be regarded as a tool. It does not
define any particular object for the
declaration, and presumes that all
applicable laws and regulations are
observed. These general requirements
are applicable to all sectors.
A supporting framework
to substantiate
the declaration
For a Supplier’s Declaration of
Conformity to be more consistently
applied, where consistency is believed
desirable, an addition to ISO/IEC DIS
17050-1, designated ISO/IEC 17050-2,
Conformity assessment – Supplier’s
declaration of conformity – Part 2 :
Supporting documentation (previ-
ously ISO/IEC 17049), was initiated
at the same time that ISO/IEC 17050-1
began. Part 2 of the standard provides
a supporting framework to substanti-
ate the declaration, particularly where
legal requirements are involved, and
secondly, to encourage government
authorities to implement SDoC in
consistent ways so that the conformity
process is simplified. ISO/IEC 17050-2
should also result in even greater con-
fidence for authorities, customers and
users that specified requirements are
being met.
The responsibility for devel-
oping ISO/IEC 17050-1 and ISO/IEC
17050-2 was given to CASCO WG
24.
Suppliers of products, proc-
esses, services and systems that follow
the provisions of ISO/IEC 17050-1 and
ISO/IEC 17050-2 should give govern-
ment authorities, regulators, customers
and users greater confidence that the
object of conformity meets specified
requirements. Regulators, customers
and users will know that a supplier that
issues an SDoC that conforms to ISO/
IEC 17050-1 and ISO/IEC 17050-2
has thoroughly tested and evaluated the
object. Their confidence that the speci-
fied requirements have been met will
be enhanced. Since the provisions of
ISO/IEC 17050-1 and ISO/IEC 17050-
2 are clearly articulated, organizations,
both large and small, that use the stand-
ard, regardless of industry sector or
how widely known a brand or supplier
may be, should increase the confidence
in their declarations.
Giving SDoC its rightful
place
SDoC has become an important
way for suppliers to provide assurance
that an object of conformity meets
specified requirements. It reduces
costs and speeds development of new
products, processes and services. It
is a valuable conformity assessment
alternative that detractors have claimed
lacks accountability. However, the new
standards now under development,
the future ISO/IEC 17050-1 and
ISO/IEC 17050-2, (at present, at the
draft International Standard stage) will
help ensure uniform SDoC criteria and
requirements worldwide, and make
SDoC an even more attractive and
valuable option than it already is for
those who currently employ SDoC.
Confidence in the conformance of a
product, process, service or system
will be uniformly understood, more
widely accepted and more broadly
applied.
The sooner these International
Standards are completed and accepted,
the sooner their benefit can be real-
ized.
Certification
About the author services in
Before his retire- developing
ment in 2000,
Joel Urman countries
spend 34 years
working for the
IBM Company
where he held
By Mr. Fabio Tobón, Executive Why a nationally based
jobs in market- Director, Colombian Institute certification body ?
ing, technical for Standardization and
support, strategic Certification has become big
Certification (ICONTEC) business. With the amount of money (in
planning and data
security before becoming Program the billions of USD) involved in a busi-

Director of Standards in the IBM
Corporate Offices in 1992.
In that capacity he worked to develop
International Standards within ISO/IEC
JTC 1, CASCO and ANSI. Mr. Urman
also was chairman of ANSI’s International
Conformity Assessment Committee. He is
the recipient of the ANSI Edward Lohse
Medal for his contributions to national and
international standardization and conform-
ity assessment. Mr. Urman is currently the
convenor of CASCO’s WG 24 on
Supplier’s Declaration of Conformity.
C
ertification of products and
management systems have
gained visibility in today’s
world when we are facing a globaliza-
tion of the economy, an openness of
the markets, and an increase in world
trade. We all, however, have to main-
tain the added value of certification to
our customers if we want the system
to prevail.
ness that grows faster than most, the
appearance of not very ethical actors
is likely to occur. Yet the credibility
of the system, in many instances, rests
upon the ethical behaviour of our insti-
tutions.
The advantage of being, like
ICONTEC (the Colombian Institute
for Standardization and Certification),
a not-for-profit organization based in
Colombia itself with worldwide rec-
ognition of its certificates is big for
ISO Focus February 2004 25
Main Focus
developing countries such as ours. If it
is solely the so-called multinational
companies that come to our countries
to offer these important services, the
costs to our local manufacturers and
to the service industry will increase.
Being local offers the additional
advantage of being better acquainted
with the country’s codes of behaviour
and its local customs.
A locally-based certification
body helps build capacity in a coun-
try which, in the long run, is profit-
able, since that country will not be
depending on foreign resources. The
conformity assessment scheme of the
country is better developed when there
are reliable local players.
The difficulties we face
For a nationally based institu-
tion, it is difficult to compete in the cer-
tification business. The “ competition ”
usually uses the argument that our insti-
tutions are only recognized within the
country itself, and that our certifications
do not enjoy worldwide validity. We
have been witness to how in our coun-
try, some of the so-called multinational
certification bodies have tried to “ buy ”
market share, using some not very ethi-
cal approaches, reducing the number of
audit days and the tariffs, and thereby
rendering competition very difficult.
When a conformity assessment
scheme is established in a developing
country, its credibility is very often put
into doubt by the developed or indus-
trialized countries since they tend to
believe that there is not enough knowl-
edge and capacity in the developing
country to have a credible system. In
the last resort, it is costly to a nation-
ally based organization to have a certi-
fication system recognized worldwide.
Certification and
ICONTEC
Our organization’s mission is
to be a service company that helps
to increase the competitiveness and
productivity of the industry and the
service sector in the countries it serves
with the aim of improving the quality
and standard of life of the consumers.
26 ISO Focus February 2004
We offer product, systems and
personnel certification, and have a
more than 70 % market share in the
field. The largest and more important
companies working in the country
– national and multinational – are our
customers for this service.
On product certification,
ICONTEC has granted more than 450
Quality Marks to different companies,
covering more than 10 000 products in
the market. We are in association with
UL to be their inspection body in the
country for the UL electric safety mark.
We also certify Natural Compressed
Gas installations and vehicles.
On systems, we are provid-
ing certification on quality against
ISO 9001:2000, and on environment
against ISO 14001, HACCP, OHSAS
18001 and QS 9000 for the automotive
industry.
Regarding personnel, we are
providing certification on different
activities of interest for Colombian
industry and the government.
The growth in the number of
certifications provided by our institu-
tion is exponential. One reason for
this is the economic support that the
Colombian government has given the
SME (Small and Medium Enterprises)
to be more competitive. This financial
help has made it possible for Colombia
to be the fastest-growing country in
terms of quality system certification in
all of the Americas.
How to get credibility
In many instances, the accred-
itation bodies in developing countries
are not members of the Multilater-
al Recognition Arrangements (MLA)
developed by the International Accred-
itation Forum (IAF), so that the accred-
itation they dispense in the country has
only limited value. If such is the case
– as indeed it was for Colombia and
ICONTEC – there is a need to look for
accreditation outside the country from
a member of the International Accred-
itation Forum Multilateral Recognition
Arrangements (IAF MLA). This gives
worldwide credibility to the certifica-
tions granted – but such certification
comes at a cost and is difficult to main-
tain. ICONTEC, looking for recogni-
tion of its certification, was accredited
in 1996 by the German accreditation
body DAR-TGA (Deutsche Accredi-
tierungs Rat – Trägergemeinschaft für
Akkreditierung GmbH – Association
for Accreditation).
The qualification and follow-
up of the local auditors has to be
done with a well established “ career
plan ” that needs to be approved by
the accreditation body. We also have to
stick strictly to the international con-
formity assessment guides developed
by ISO/IEC and implemented by IAF.
At ICONTEC we were also
aware that we have to become compet-
itive in the international certification
world and to become, in fact, a mul-
tinational certification body ourselves.
This is why we opened offices and
representations in different countries
in Latin America.
One useful tool to help us to be
recognized worldwide was to become
a member of IQNet, the International
Certification Network. The members
of IQNet are present and work in more
than 100 countries, and jointly we
have issued more than 25 % of the ISO
9001:2000 certifications in the world.
Product certification
is a problem
System certification has, then,
become popular, and accounts for the
bulk of certifications provided today.
This type of certification is not the real
problem for our developing countries.
The real problem – and the
trade barrier – is product certification.
Every country has different require-
ments for certification of products, and
very often does not accept other coun-
tries’ certifications, blocking the entry
of products from abroad. There has to
be agreements between the countries,
and this then becomes cumbersome
and costly.
Besides this, there are a large
number of “ private ” certification
schemes developed by persons or
institutions that, even though they are
promoted as voluntary, are becom-
ing mandatory de facto. In these
schemes, the “ owners ” set the rules
and the charges, making it difficult
for national-based certification bodies
to get accreditation. In these cases, the
local industry in our countries bears
the burden of heavy costs if it wants to
penetrate these “ protected ” markets.
The avalanche of these certifi-
cation schemes has created what I term
a “ maraña of certifications ” – or a big
mess – that is imposing real restric-
tions on world trade. Ideally, IAF or
another body could attempt to regulate
Repeated export bans
the validity and worldwide recognition
of product certifications in the same Fishing for Fish exports grew from a value of USD
way they have with system certifica-
tions.
Quality nets 5,308 million in 1991 to USD 39,78
a big catch million in 1996, but fell to USD 28,8
million in 1997 due to a fish export
ban by the European Union over fish
quality and safety concerns. This ban
About the author was lifted in July 1998, but then in
By Mr. Sam Balagadde, 1999 April another ban was imposed
Fabio Tobón has Agricultural Head, Technical on fish and fishery products originat-
a degree as an Liaison Division, Uganda ing from Lake Victoria because of the
agronomist from
National Bureau of Standards concern that some fishermen were
the Universidad
(UNBS) suspected of catching fish using pes-
Nacional in
ticides. This ban was lifted in October
Bogotá,

Colombia, and a
Master’s degree
in Agricultural
Engineering and
Administration
from the University of Minnesota, USA.
He was Sales and Marketing Manager of
Caterpillar Construction and Industrial
Machinery in Colombia for ten years,
Professor at the Universidad Nacional in
Bogotá for five years, and Dean of the
Agronomy School, before becoming in
1992 Executive Director of ICONTEC,
the national standards body of Colombia.
He was a member of ISO Council
(1997-1998) and has twice been –
including at present – a member of ISO
Technical Management Board.
T
he Uganda fish processing
industry is situated on the
banks of Lake Victoria, and
Nile perch is its main raw material.
The fisheries industry employs over
700 000 people involved in various
fishing activities including fishermen,
fishmongers, fish transporters and
boat builders. Local companies have
been exporting most of their fresh
or frozen fillets to European Union
(EU), Japan, Hong Kong, Singapore,
Australia, Dubai, Israel and the USA
since 1989. The current capacity of
fillet processing in Ugandan factories
is estimated to be at least 400 tonnes
of fish per month.
2000 after the Department of Fisheries
Resources (DFR), set up a programme
of monitoring the levels of pesticides
and heavy metals in fish, water and
sediments from Lake Victoria, and
also intensified monitoring and sur-
veillance of fishing activities on the
lake. These repeated fish and fishery
export bans by the European Union on
fish originating from Uganda had dis-
rupted the growth of this sector, which
in 1996 was Uganda’s second largest
foreign exchange earner after coffee
(MPED, 1998).
Early in 1997, European coun-
tries, notably Spain and Italy, detected
high levels of bacterial contamination
ISO Focus February 2004 27
Main Focus
including Salmonella in fish from Lake
Victoria. The two countries requested
the European Union to impose a ban
on fish from the riparian states of Lake
Victoria. Following an outbreak of
cholera in East Africa, the EU banned
importation of fresh and chilled fish,
and imposed mandatory tests on fro-
zen fish, fruits and vegetables from
East African countries.
The second and longest ban was
imposed in March 1999 for pesticide
residues for which the Government left
the responsibility to the Department
of Fisheries Resources (DFR) and
the Competent Authority, i.e. Uganda
National Bureau of Standards (UNBS).
The EU demanded a comprehensive
monitoring programme, which would
determine levels of organochlorine
pesticides, organophosphate pesticides,
PCBs, and trace elements in fish, water
and sediments from the lake.
Crisis in the industry
The loss to Uganda in terms of
reduced returns as a result of the con-
tinued ban from March to July 1999
was estimated at USD 36,9 million.
Loss to the fishing community owing
to reduced prices and lower activity
was USD 1 million per month.
Of the 11 factories operational,
three were closed, and the remain-
ing were operating at 20 % capacity.
Consequently, 60-70 % of those direct-
ly employed were laid off.
Around 35 000 people involved
in various fishing activities including
fishermen, fishmongers and fish trans-
porters became jobless. Those remain-
ing indirectly employed earned less
than one third of their normal earnings,
and families and their dependants were
affected.
Other related industries like
packaging, transport and the economy
in general were directly affected and
all involved suffered direct conse-
quences from the EU ban on fish.
Veterinary inspectors
The European Union missions
of Veterinary Inspectors carried out
inspections to assess the health control
28 ISO Focus February 2004
Uganda and Nile perch
Uganda lies in East Africa and covers
241 000 km ². Lakes account for
44 000 km ² of its territory. The largest
of these lakes is Lake Victoria with a
surface area of 31 000 km ² within
Uganda’s border. Its total surface area
is 68 000 km ² of which 45 % is in
Uganda, 49 % in Tanzania and 6 % in
Kenya.
Nile perch is native to Lake Albert,
and is the most important commercial
fish species in Uganda. It was intro-
duced into Lakes Kyoga and Victoria
from Lakes Albert and Turkana dur-
ing 1950’s and early 1960’s. The pur-
pose of the introduction was for the
Nile perch to feed on small-sized fish,
especially haplochromine cichlids
(Nkejje) which were at that time
abundant but not commercially
exploited, and convert them into a
larger fish of higher commercial and
recreational value (Graham, 1929).
and monitoring of production condi-
tions to comply with the EC Directive
91/493, inspecting for overall hygiene
standards, for guarantees regarding
absence of pesticide residues in fish,
and for harmonization and guarantees
regarding pesticide residues. The prob-
lem areas (below) were pinpointed.
Structure of Competent Authority
One problem identified was the
structure of the Competent Authority.
There was lack of a clear line of com-
mand since two bodies, namely UNBS
under the Ministry of Tourism, Trade
and Industry, and the fish inspection
services in the Department of Fisheries
Resources (DFR), were involved.
Inspection
The inspectors of DFR did not
have clear guidelines and standard
operating practices in particular with
regard to inspecting batches of fish
being landed, hygiene conditions at
landing sites, sampling procedure
records of their own activities and
documents required for traceability of
origin and transportation of fish.
Laboratories
Non-availability of a suitable
laboratory for pesticide residue analy-
sis was a key concern. The perform-
ance and capacity of the Government
chemists in charge of performing pes-
ticide residue analysis in fish products
were considered totally inadequate.
Legislation
The Fish and Crocodile Act had
not been upgraded to meet the present
requirements of the fishery industry.
Decentralization
District Fisheries Officers (DFOs)
were not answerable to Department of
Fisheries Resources (DFR), and hence
were not following the instructions
regarding hygiene and handling of fish
as required by EU regulations.
Landing sites
Most public landing sites had not
been upgraded and their facilities did not
meet minimum EU requirements.
Fish handling
Fish was generally handled
unhygienically throughout the chain.
Impact of UNIDO’s support
The focus was put on the fish
sub-sector to address the ban imposed
on Uganda’s fish exports to the EU and
its related economic consequences.
UNIDO’s (United Nations
Industrial Development Organization)
support contributed greatly to the lift-
ing of the European Union ban, hence,
the resumption of exports to the EU.
UNIDO provided technical assist-
ance in preparing responses to the EU
Commission regarding guarantees put
in place by Uganda to meet the EU
requirements.
Fish Inspection Services
The fish inspection services
have been streamlined and the capac-
ity of the Competent Authority (DFR)
strengthened through training of inspec-
tors, provision of equipment and intro-
duction of a fish inspection manual.
Achievements in this sub-sector will
be used as a model for other sub-sec-

tors sensitive to the public health of
the consumers and/or having export
potential. The inspection system will
be used in development of the Food
Control System.
Laboratories
Laboratories were provided
with equipment and technical support,
with the UNBS Microbiology Labora-
tory being fully equipped. A Quality
Management System was internation-
ally accredited by SANAS (South Afri-
can National Accreditation System) in
April 2001. Chemiphar (U) Ltd., a pri-
vate laboratory, which benefited from
UNIDO support, was approved by the
EU inspectors for pesticide residue
analysis. The Government Chemist
Analytical Laboratory is still under-
going upgrading. Availability of inter-
nationally recognized laboratory serv-
ices locally in Uganda will greatly
facilitate exports of products and also
reduce on the costs of laboratory anal-
ysis abroad.
Fish processing pilot enterprises
The enterprises have been able
to implement ISO 9000 for Quality
Management and the principles of
HACCP. All enterprises have been cer-
tified to ISO 9001:2000. As a result of
strengthening the fish inspection serv-
ices, Ugandan fish got access to the US
market, which demanded for approved
HACCP systems from the fish facto-
ries. In addition, the enterprises have
improved in quality management
through introduction of the uniform
“ Code of Practice ”. Experiences in
these pilot enterprises will also act as
a model for other sub-sectors.
UNIDO proposed hygienic fish
handling practices on the lake and at
landing sites in conformity with the
EU quality/safety requirements. Two
pilot boats were constructed and hand-
ed over to Uganda Fish Processors
and Exporters Association (UFPEA)
to conduct trials for assessment of the
socio-economic and technical impact.
Based on the results, the most suitable
designs will be disseminated to the 20
local boat builders already trained in
boat-building and design by UNIDO,
the whole fishing fleet and regulatory
authorities to facilitate adoption.
A new economy
With the resumption of fish exports
to the EU, the increased revenue from
exports strengthened Uganda’s shilling.
Factories resumed operations at full
capacity. One of the factories earlier
closed due to lack of business is prepar-
ing to reopen. Laid off staff during the
UNIDO provided Technical Assistance
to the fish factories on HACCP and
quality systems implementation.
A Code of Practice was prepared
and adopted by all the factories. A
GMP audit software was installed
in all factories exporting fish to the
European Union. As a result, all fish
factories introduced and implemented
HACCP, five factories had their quality
manuals, and three were certified ISO
9002. In 2002, all the fish factories
upgraded and were certified to ISO
9001:2000.
ban have been recruited. The fisherfolk
are back earning their livelihood.
Uganda was harmonized and
promoted to “ List I status ” as from 15
October 2001, which made it possible
to export to any EU member country
without restriction. This resulted into
increased revenue from the fish exports.
About the author
Samuel G.L.
Balaggade is
Senior Standards
Officer and
Acting Head of
the Technical
Liaison Division
at the Ugandan
National Bureau
of Standards
(UNBS). Among
other activities, he is engaged in the
management of liaison activities between
UNBS and domestic and international
institutions including ISO, and the
National WTO Enquiry Point. Previously,
he was involved in the sampling, testing
and inspection of food products both for
UNBS and for businesses in the coffee
and dairy industries. He has held commis-
sions and secondments with UNIDO.
Sam Balaggade has a bachelor of
Technology (Food Sciences) degree.
ISO Focus February 2004 29
Developments and Initiatives
The world of mechanical
contraceptives is far from static
By Mr. Graham Holloway, condoms reaching the consumer is con- competing needs of manufacturers
Chair ISO/TC 157, Mechanical tinually improving. Participants in the and consumers, in order to attain the
work of ISO/TC 157 include manufac- elusive goal of specifying “fitness for
contraceptives, SABS (South
turers, researchers and those involved purpose”, but it is also of paramount
Africa) in the testing of mechanical contra- importance that the needs of major
ceptives, consumers, regulators, the users of standards such as government

T
he challenge for a technical
medical profession, social marketing procurement agencies, regulators and
committee engaged in standar-
agencies, family planning and natio- marketing agencies working in the
dizing mechanical contracep-
nal and international health agencies. social field be taken into account. The
tives is to keep pace with emerging
Strong representation from the World medical profession provides input on
needs in the marketplace, with new
Health Organization (WHO) and from the practical consequences of the use
materials and technologies, and to
Consumers International complete the of medical devices, particularly in the
take into account modern quality
picture, and ensure that meetings of the fields of IUDs and diaphragms, and the
assurance techniques, whilst never
committee these days attract in excess needs of specific consumer groups such
losing sight of those basic needs.
of 100 delegates, a far cry from the first as those social workers in the field,
In recent times, the basic needs
meeting in 1975, when 33 delegates especially in developing countries
of people for reliable means of sexual
were present! It is also noteworthy that where affordability of contraceptives is
protection and contraception have
many newer, less experienced, manu- a major issue, have to be accorded full
not changed, but have become more
facturers of condoms are represented consideration. To ignore, or fail to take
complex as a result of changing sexual
on ISO/TC 157, as their participation in fully into account, the needs of any of
practices, cultural and social issues, the
the ongoing development of standards the above groups of stakeholders would
practical demands of modern lifestyles
in this field affords them a learning be to fail the most basic test of standar-
and, not least, the continuing presence
opportunity that is second to none, and dization – that of ensuring that the ISO
of sexually-transmitted infections – in
keeps them abreast of developments in standards developed are actually used.
particular the HIV/AIDS pandemic,
research.
the impact of which on some nations
in the developing world has yet to be
fully felt, or even acknowledged. Different manufacturers
produce varying qualities
of finished product
Pooling knowledge
to ensure quality and Furthermore, a standard should
ideally test for characteristics that are
reliability clearly correlated with its fitness for
The work of ISO/TC 157 covers purpose, that is, the condom providing
Döka Maschinenbau GmbH

intra-uterine devices (IUDs), re-usable reliable protection in use while mini-

female rubber and silicone contracep-
tive diaphragms, single-use male latex
condoms, and single-use male condoms
made of synthetic materials; additional
areas of interest are the growing demand
in some parts of the world for female
condoms, and even the possibility of
extending the scope of the committee
to include work on tubal occlusion
devices. By far the most wide-ranging
area of activity however is, not surpri-
singly, that of male condoms, where a
wide variety of stakeholders participate
in pooling their knowledge to ensure
that the quality and reliability of male
30 ISO Focus February 2004
Single-chamber condom burst testing
device.
Development of International
Standards in such an area imposes
extra constraints on the work of the
committee. Not only is it necessary
to strike a balance between the often
mizing interference with sexual satis-
faction. Yet little research on these cor-
relations was available when the work
started and while the situation has
improved somewhat over the years, in
part due to the efforts of the committee
and some regulators, scarcity of this
kind of evidence continues to provide
a major challenge for standardization.
To illustrate some of the
issues involved, consider the standard
for male latex condoms, ISO 4074:
2002, Natural latex rubber condoms
– Requirements and test methods, and
its supporting standards.

Latex is a naturally occurring
material, and as such is subject to
variation in quality. While available
technology makes possible the con-
sistent formulation of latex rubber, it
remains a fact that different manu-
facturers of latex condoms produce
varying qualities of finished product.
Condoms are mass-produced articles
(the worldwide market is estimated
at around 13 billion pieces at a cost of
around USD 4 billion) and therefore
any standard for the finished condom
has to take into account – and include
tests for – those types of failure that
are associated with poor manufactu-
ring practice or poor raw materials
control. One such test involves the
detection of holes in the material of a
condom. Various techniques have been
proposed for this, ranging from filling
the condom with water and squeezing
or rolling the filled condom to detect
leaks, to electrical conductivity tests
aimed at detecting the passage of a
current through the wall of a condom
(since latex rubber is an insulator, the
passage of a current is indicative of a
hole).
While tests to detect holes
measure the prevalence of defects
(holes) in condoms, additional tests
are used to determine the overall
quality of the latex films. These tests
determine the behaviour of a condom
when placed under internal pressure,
by inflating the condom with air and
recording the volume and pressure at
which a burst occurs.
Manufacturers are
required to indicate
the shelf life of their
products
The packaging of any article is impor-
tant in protecting the product from
damage during transportation and
storage, and this is especially true
in the case of latex rubber condoms.
ISO 4074 contains a test to determine
whether the protective foil package of
a single condom exhibits any leaks.
Typically this might be due to delami-
nation of an inferior foil used for the
packaging, with potentially disastrous
results for the quality of the product
when eventually used, as the ingress
of air is particularly destructive to a
latex film.
“ Stakeholders pool their
knowledge to ensure that
the quality and reliability
of condoms is continually
improving.”
With a high-volume, disposable
article, the issue of shelf life becomes
relevant, and again, this is especially
important in an article such as a con-
dom, where the properties of the latex
film are known to change over time.
Preventing deterioration of latex con-
doms in the many tropical countries
which are suffering most intensely
in the AIDS pandemic and importing
large volumes of the product became
a public health issue recognized by
the World Health Organization and
consumer groups. This led to the
committee developing more rigorous
standards for stability over the last
five years. In ISO 4074, manufacturers
are now required to indicate the shelf
life of their products, and to base their
claims on objective evidence, which in
practice might come from either real-
time studies or from statistically-based
accelerated aging data. As time goes
on, as a direct result of the require-
ments of ISO 4074, more and more
manufacturers are compiling real-time
data, and are becoming able with grea-
ter certainty to estimate the shelf life of
their products.
As mentioned earlier, defining
quality for a medical device cannot be
based solely on the consistency of the
physical characteristics of a batch of
the finished product. For most mecha-
nical contraceptives, proof of the safety
and efficacy of the product, using pre-
clinical and clinical trials, are part of
the process of obtaining approval for
marketing. The development of robust
standards for products such intra-ute-
rine devices or condoms made from
innovative materials is increasingly
based on both the physical assays and
requirements for studies of safety and
efficacy in use.
Compatibility with
other products and new
materials
ISO/TC 157 has therefore
established a working group to make
recommendations, in the form of a
guidance document, on the conduct
of clinical investigations. Owing to
the difficulty experienced in obtai-
ning consistent and reliable data from
such personal testing, it is important
to create a sufficiently uniform test
method to eliminate as many variables
as possible. In addition, clinical inves-
tigations must have the proper design
and rigour to ensure that conclusions
from such studies can be realistically
extrapolated to the general popula-
tion.
ISO Focus February 2004 31
 Developments and Initiatives
Electric condom leakage
test rig.
(polyurethane, etc.)
have completely diffe-
rent properties to latex
Döka Maschinenbau GmbH
Striving to meet
ever-increasing demands
It can thus be seen that stan-
dardization in the world of mechanical
contraceptives is far from static, as
the industry strives to meet ever-

rubber, and therefore increasing demands for consistency

demand a new approach. of product and reliability in use. It is
ISO/TC 157 is therefore essential, however, that social marke-
in the process of prepa- ting agencies, governments, regulators
ring a committee draft and procurement organizations, and
of a separate standard bulk purchasers in the private sector
for condoms made from understand the need to base their pro-
synthetic materials. duct acceptance criteria on standards
Similarly, the – as only by doing so will they be able
Most condoms are supplied technology for intra-uterine devices to ensure that inferior products are
with a lubricant already applied to the has evolved enormously over the kept out of the marketplace. The grea-
latex film. However, some users desire years. The “newer” copper IUDs, now test challenge facing ISO/TC 157 over
that additional lubricants or other addi- available for almost 20 years, have the next decade for latex condoms is
tives, such as spermicides, be added to very low rates of problems while pro- therefore less likely to be the continual
the condom before use. It is essential tecting against pregnancy as efficiently upgrading of the standards themselves,
that such additives be compatible with as tubal ligation. The current challenge but the educational role of ensuring
the latex film. As an example, a com- for IUD standardization is how to that the standards are more and more
monly purchased petroleum jelly, if protect women by requiring today’s widely used. Convincing manufactu-
applied to a latex rubber condom, is high standard of performance without rers and bulk purchasers of the value
known to cause deterioration of the stifling innovation. Proposals from of standards is only part of the process,
latex film. consumer organizations to require though. Ultimately, the goal must be
The aspect of compatibility higher standards of efficacy are now to educate the consumer to demand
with other products therefore plays a under consideration. proof of conformity to International
significant part in the deliberations of Standards such as ISO 4074; only then
ISO/TC 157.
Any standard for a mass-produ-
“ The goal is to educate will the full value of these standards be
realized.
ced product lays down those attributes the consumer to demand
of quality that are deemed necessary proof of conformity to
in the final product, but the task of the
manufacturer remains to improve his
International Standards About the author
production process in such a way as to such as ISO 4074.”
Graham
ensure that the final product conforms
Holloway has
to the standard. A guidance standard, over 20 years’
ISO 16038, is now in the final stages of experience in
preparation, with the aim of providing standardization,
helpful information for manufactu- and is currently
rers of condoms in clarifying the intent Head of Strategy
behind the test methods in, and the and Systems
interpretation of, the results generated Development for
from ISO 4074. Standards South
Africa, the stand-
Döka Maschinenbau GmbH

While manufacturing tech-

ards-generating arm of SABS. Originally
nologies continuously improve, and
from Oxford, England, and now a natural-
these need to be addressed in product
ized South African, he chairs ISO/TC 157,
standards, occasionally a completely Mechanical contraceptives.
new product comes onto the market,
that dictates a complete re-think of
existing standards. In the case of
condoms, new synthetic materials are
starting to emerge as competitors for Manually operated condom dry testing
the traditional latex. These materials machine.
32 ISO Focus February 2004

Once learned, never
forgotten
T
hink and act in an environmen-
tally-friendly way from an early
age, and you will always do so:
such is the message behind The Kids’
ISO 14000 Programme. Drawing on
the organizing principle of the ISO
14000 standards on environmental
management systems, this innovative
programme was created and is oper-
ated by the Japanese non-profit, non-
governmental organization ArTech
(International Art and Technology
Cooperation Organization) in Tokyo.
The thinking goes thus : if you
instil an environmentally positive
attitude of mind in children, they will
grow up with “ conditioned reflexes ”
that will ensure environmental con-
sciousness throughout their lives. They
in turn will spread this consciousness
to their school friends, around their
families, and later to their own chil-
dren, thus building up a broad national
framework of support. And what bet-
ter as a basis of this education than the
Plan-Do-Check-Act (PDCA) cycle, at
the heart of the ISO 14000 standards
on environmental management sys-
tems ?
Children implement PDCA in
their own homes to :
• measure environmental aspects
such as water and energy consump-
tion;
• set targets to reduce negative
impacts;
• achieve concrete results and com-
pare them with the target;
• draw lessons from the experience
in order to make further improve-
ments.
Children in this way learn
by experience that they can reduce
negative environmental impacts and
improve environmental performance.
The programme, that is suitable for
children from the age of 10, comprises
four graded levels (introductory, pri-
mary, middle and highest) with the
children progressing from one step to
the next with the aid of workbooks and
materials. The work is permanently
evaluated and those that reach the
final goal are awarded a Certificate
from the Kids’ ISO 14000 Programme
International Committee.
The Kids’ ISO 14000 Pro-
gramme encourages participants to
network with children engaged in the
programme in other schools and com-
munities, both nationally and interna-
tionally. Children learn by direct expe-
rience that cooperation and teamwork,
regardless of frontiers, multiplies the
efficiency and effectiveness of their
environmental management efforts.
Tangible proof
And it works ! The proof :
50 000 Japanese children, and the
number is growing exponentially on
the international as well as the national
level, have adopted this approach and it
has tangibly and demonstrably helped
to preserve the environment. Professor
Takaya Kawabe, President of Ar-Tech,
the originators and operators of the
project, says : “ It is evident that the
environmental education of children
and young people is now one of the
keys to the solution of global envi-
ronmental problems and for achieving
sustainable development.”
The secret ? Involving the chil-
dren, giving them a “ road map ” that
they can develop individually and
opening them up to networking with
others, locally, nationally and interna-
tionally, working towards a similar goal
of preserving the environment, ensur-
ing minimum damage is done to it, and
promoting sustainable development.
Prof. Kawabe explains : “ The
three principal aims of the Kids’ ISO
14000 Programme are :
• firstly, to stimulate environmental
awareness among children ;
• secondly, to teach children to imple-
ment a simplified form of the Plan-
Do-Check-Act cycle at the heart of
ISO 14001 and use it to monitor and
reduce energy and water consump-
tion in their homes, and,
• thirdly, to encourage the formation
of networks of these children, both
locally and worldwide, in order for
them to work together on global
environmental issues.”
The ISO role
With a view to expanding the
implementation of this Kids’ ISO
14000 Programme, and broadening the
use of ISO 14000 principles through
application of them by children from
an early age on a worldwide scale,
ISO is cooperating in the programme
and helping to promote it. The
United Nations University (UNU) is
co-operating on it, and the United
Nations Environmental Programme
(UNEP) also supports it. In 2003,
ISO Secretary-General Alan Bryden
and ArTech President Prof. Takaya
Kawabe signed a Memorandum of
Understanding in Tokyo, Japan, con-
firming an earlier agreement between
the two organizations in October 2002,
since when ISO has lent its name and
logo to the programme.
ISO Focus February 2004 33
Developments and Flowchart of basic activities for
Initiatives implementing the Introductory Level
of The Kids’ ISO 14000 Programme
by national bodies (NB), enterprises
ISO has published an informa-
and other organizations
tion brochure 1) describing this pro-
gramme, explaining what it consists
of, what ISO’s involvement is, how it
works, and how to get involved. An Contract
electronic version (PDF and HTML NB
format) is available for downloading
from ISO Online. More information,
such as sample pages of the Intro-
ductory Level workbook that repre-
sents the model that can be followed Model operating manual
for producing a national version and
updates, can be found on ISO’s Web
Guide book for production of national version at Introductory Level
site at www.iso.org/kidsiso14000. Model Introductory Level workbook
Model teachers’ manual
Participating NB
in the programme
As the creator and overall coor-
dinator of the programme, ArTech 2) is
Edit and translate workbook and
the initial contact for enquiries about manuals, taking into account
participating in or supporting the pro- local culture and conditions
gramme, about whether it is operat- NB
ing in a particular country, whether any
partnerships have been established with
local organizations, and the availability
of material in the national language.
ISO is encouraging the national First edition of national version of teachers’ manual
standards institutes of 148 countries
that make up its membership to First edition of national version of Introductory Level workbook (WB-I)
become programme facilitators and First edition of national version of operating manual
national partners of ArTech.
In the public sector, ISO mem-
bers could consider contacting and
establishing partnerships around the Teachers’ manual
programme with ministries and oth- WB-I
er administrations – central, regional NB
and local – responsible for areas such WB-I
as education, youth, the environment,
trade, consumers, national heritage
Schools
and culture. WB-I Child’s
In the private sector, potential
partners and sponsors could include family
industry and business associations,
WB-I Schools
individual businesses and consumer
organizations. NB WB-I
1) The Kids ISO 14000 Programme, 24 pages,
A5 (oblong), ISBN 92-67-10388-1, available WB-I Evaluation sheets
free of charge from the ISO members or
the ISO Central Secretariat.
WB-I NB Data sheets
2) Prof. Takaya Kawabe, President and
Director General, ArTech (International Art & Evaluation sheets Schools
Technology Cooperation Organization),
Tomigaya 1-39-2, Suite 104, Shibuya-ku, Data sheets WB-I
Child’s
Tokyo, Japan 151-0063 ; Tel. + 81 3 3467 6250 ; family
Fax + 81 3 3467 6277 ; E-mail kawabe@
artech.or.jp ; Web www.artech.or.jp
Evaluation sheets
34 ISO Focus February 2004
New this month
Lighting fires Freight container
without burning seals will help
down the house combat terrorism

T
he number of fires and burn

W
ith international trade
injuries caused by faulty “ util- largely dependent on freight
ity lighters ” should be reduced containers, a new ISO spec-
thanks to a new ISO International ification on the mechanical seals used
Standard defining safety requirements to protect their contents has a huge
for these devices. potential to improve security measures
Utility lighters – also known as taken against terrorism, theft, smug-
“ grill lighters ”, “ fireplace lighters ”, gling and illegal immigration.
“ lighting rods ” or “ gas matches ” ISO/PAS 17712:2003, Freight
– can present dangers such as exces- containers – Mechanical seals, offers
sive flame heights, flaring, spitting a set of recommendations to assist cus-
and sputtering, and during refueling. ISO 22702 will be useful for toms authorities, manufacturers and
They have also been known to rupture the manufacturers of utility lighters, users of freight containers in air, sea,
or leak gas when dropped or when government agencies concerned with road and rail transport.
exposed to heat, or continue to burn consumer safety, testing laboratories Customs, trade and transport
even when the trigger is released. evaluating conformity with the stan- organizations worldwide use mechani-
Edward Lewiecki, convenor of dard as well as groups concerned with cal seals to ensure the integrity of con-
the ISO working group that developed consumer product safety – and attor- tainerized cargo while moving it from
the new standard, ISO 22702:2003, neys acting in liability cases. point to point within the supply chain.
commented : “ Utility lighters, being The new standard is the work Mechanical seals are used to secure
flame-producing devices, can in the of ISO technical committee ISO/TC the freight container in such a manner
same way as other flame sources, pres- 61, Plastics, working group WG 1, that provides an indication of tamper-
ent a potential hazard to the end-user. Cigarette lighters. ing with the seal if an attempt is made
The purpose of ISO 22702 is to estab- to open the container doors. With the
lish requirements for utility lighters in concerns and need for increased secu-
order to ensure a reasonable degree of rity, the quality and integrity of the seal
safety when used for intended purpos- is critical.
es and reasonable foreseeable misuse
of such lighters.”
ISO 22702:2003, Utility
lighters – General consumer-safety
requirements, provides safety speci-
fications for utility lighters which
should be taken into account by their
manufacturers before they are put on
the market for consumer use. It also
includes requirements on the refilling
of utility lighters, product marking,
instructions and warnings, test meth-
ods as well as functional and structural
integrity requirements.
“ The major benefit of this safe-
ty standard will be to provide consum-
ers and other parties some degree of
assurance that a technical risk analysis
of this product has been conducted by
an international group of experts in the
lighter field. A utility lighter conform-
ing with the standard and used in the
intended manner presents very little
danger, ” further noted Mr. Lewiecki.
ISO Focus February 2004 35
New this month
“ The use of ISO/PAS 17712 is
expected to result in better seal per-
formance and increased in-transit con-
tainer security,” said Mike Bohlman,
Chair of the ISO technical committee
that developed the new document.
“ What’s more, the biggest increase
in in-transit security will come about
because customs authorities now have
a basis to require use of a high security
seal based on the new document.”
ISO/PAS 17712 establishes
uniform procedures for the classifica-
tion of mechanical seal types and their
UNIDO

requirements, as well as the accept-

ance and withdrawal of acceptance
of mechanical freight container seals
based on a series of testing methods.
The new document has been
issued initially as an ISO Publicly
Available Specification (ISO/PAS) due
to the immediate need for clarification
and guidance on security seals for
freight containers. It is based on mate-
rial developed by the World Customs
Organization, national customs organi-
zations and national testing bodies.
The new standard is the work of
ISO technical committee ISO/TC 104,
Freight containers.
ISO 9001:2000
guidelines for the
education sector
including : elementary, medium and
higher ; special and adult education;
distance and e-learning.
ISO/IWA 2 : Quality man-
agement systems – Guidelines for
the application of ISO 9001:2000 in
education, contains the full text of
ISO 9001:2000, clause-by-clause,
followed by specific text making the
standard easier to understand and
implement by the education sector.
In addition, IWA 2 includes the full
text of ISO 9004:2000, which gives
organizations guidelines for achiev-
ing further benefits from their qual-
ity management systems through the
pursuit of continual improvement of
performance.
The IWA 2 guidelines do not
add to, change or modify the require-
ments of ISO 9001:2000 and it is not
intended that organizations be certified
to the document. However, it is intend-
oped in open workshops and organized
by a national standards institute.
IWA 2 was approved at a work-
shop held in Acapulco, Mexico, in
October 2002, and hosted by the Gen-
eral Bureau of Standards (DGN), with
the support and cooperation of the
Mexican Institute for Standardiza-
tion and Certification (IMNC) and the
National Committee for Standardiza-
tion on Quality Management Systems
(COTENNSISCAL). The Latin-Amer-
ican Institute for Quality (INLAC)
facilitated the meeting.
ISO Secretary-General Alan
Bryden commented : “ IWA 2 is
significant on at least three counts.
Firstly, it is yet another example that
ISO 9001:2000 is applicable to an
even broader range of activities than
the previous versions, in particular
to services in both private and public
sectors – which should attract new

I
SO has published specific guide-
lines for organizations in the edu-
cation sector wishing to benefit
from the implementation of ISO 9001:
2000, the latest, improved version of
ISO’s quality management system
standards that have been adopted by
more than half a million users in all
sectors worldwide.
While ISO 9000 users already
include educational establishments of
all types, the guidelines will facili-
tate implementation by the sector of
ISO 9001:2000. The guidelines are
intended for organizations at all lev-
els, providing all types of education,
ed to be useful to both internal and
external parties, including certification
bodies when the user organization is
seeking ISO 9001:2000 certification,
to asses the organization’s ability to
meet customer, regulatory and its own
quality requirements.
IWA 2 is ISO’s second Inter-
national Workshop Agreement. This is
one of several ISO alternatives to Inter-
national Standards for cases where
swift development and publication
takes priority. Compared to the usual
ISO process of developing Interna-
tional Standards through its technical
committee structure, IWA’s are devel-
organizations to reap the benefits of
implementing it. Secondly, the IWA
formula demonstrates ISO’s flexibility
in meeting the different requirements
of the market. Thirdly, the initiative for
these education sector guidelines came
from Mexico, which illustrates ISO’s
dynamism in encouraging participa-
tion by our members from developing
countries.”

36 ISO Focus February 2004

Coming up
Main Focus
The automotive industry The inter-
national vehicle regulating body, the
UN/ECE WP 29, is looking to refe-
rence international standards directly
within its regulations. This new deci-
sion to develop collaboration is sur-
veyed. As the automotive industry
introduces new technologies, looks
for clean energies, and seeks higher
performance, comfort and safety,
ISO’s International Standards for road
vehicles and intelligent transport
systems lie at the interface of develop-
ments. Jean-Martin Folz, the CEO of
PSA Peugeot-Citroën, gives his view-
point on why International Standards
help to make the industry better
geared to work seamlessly in a global
market and work for a better environ-
ment. The project leader of the
International Automotive Task Force
to harmonize quality management
requirements for the automotive
industry explains how eight out of
every 10 cars produced around the
world will contain parts or compo-
nents that have been designed and
manufactured under the ISO 9001:
2000-based quality management sys-
tem, ISO/TS 16949:2000. Hydrogen
could be a promising new clean fuel
for vehicles, and its potential needs to
be investigated. Road safety is a prio-
rity for manufacturers, and standards
are making inroads in protecting the
drivers and passengers, at the same
time as increasing the comfort of the
vehicles. ISO standards for the car
industry, in such fields as gas cylin-
ders, tyres, how dummies are used,
and ergonomic standards are making
rapid strides. Rapid changes are
taking place in the possibilities of
intelligent transport systems – what
direction are they taking ?
Developments and initiatives
Safety of toys. A Japanese expert
in a toy factory explains how
standards for toys can go beyond
strict safety, quality and environmen-
tal requirements and make them
user-friendly for both visually and
hearing impaired users by demanding
minimal readjustments.
Bar coding for the aircraft
industry. An important technical
specification defining consistent
process and the business rules and
data structure that permit industry
and government enterprises including
airlines, manufacturers and suppliers
to uniquely identify products and
parts.
Fluid power products. Fluid power
manufacturers and users have initiated
Photo : Pierre Granier
a programme to develop ISO
standards to determine the reliability
of their products by testing.
Tractors and agricultural
machinery. A survey covering a
broad range of industrial goods from
combine harvesters to lawn mowers, Dublin Core. The Dublin Core
followed by a review of the new Metadata Initiative brought together
cooperation agreed between ISO/TC librarians, digital library researchers,
23 and the OECD work on tractor content providers, and text mark-up
specifications. experts to improve discovery
standards for information resources.
The result: an ISO information
database handling standard that is
set for a big career.
Gas cylinders. Views of gas
cylinders, with a look at standards
around the re-qualification of gas
bottles and periodical tests and
inspections, including its liaisons
with UN agencies, and the design
of a gas cylinder, and where the
danger areas lie.
ISO Focus February 2004
When results count !

Global markets.
Global standards.

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