ISO Focus

The Magazine of the International Organization for Standardization

Volume 1, No. 7, July-August 2004, ISSN 1729-8709

Safe
machinery
saves

Crash test dummy

gains international acceptance
Consumers want
standards and the law
 Contents
1 Comment Alfred Sutter, Chair ISO/TC 199, Safety of
machinery – Preparing safety for all
2 World Scene
Highlights of events from around the world
3 ISO Scene
Highlights of news and developments from ISO members
4 Guest View
By Mr. Helmut Reuter, CEO of the Rieter Group, Winterthur,
Switzerland
ISO Focus is published 11 times 7 Main Focus
a year (single issue : July-August).
It is available in English.
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Manager : Anke Varcin
Editor : Giles Allen
Assistant Editor : Elizabeth
Gasiorowski-Denis Safe machinery saves lives
Artwork : Pascal Krieger and • Putting machine safety in a global perspective
Pierre Granier • Safety pays: designing machines that care
ISO Update : Dominique Chevaux • Universal and individual risk
Subscription enquiries : Sonia Rosas
ISO Central Secretariat
• Easy to operate: earth-moving machinery
• Hazards are everywhere: how to achieve functional safety
Telephone + 41 22 749 03 36
Fax + 41 22 749 09 47
• Vibration and shock affect people’s lives
E-mail sales@iso.org • Radical improvements in crane safety
• Ergonomics : the road to health, safety and efficiency
© ISO, 2004. All rights reserved. • Burning a trail ahead in protective clothing
The contents of ISO Focus are copyright • Reducing the risk of hearing damage
and may not, whether in whole or in
part, be reproduced, stored in a retrieval
• The value of statistical techniques
system or transmitted in any form or
by any means, electronic, mechanical,
34 Developments and Initiatives
photocopying or otherwise, without • Automobile safety – a dummy that can take it all
written permission of the Editor. • Best practice for information security
• Legislation and standards – partners in consumer protection
ISSN 1729-8709 • The unrelenting advance of video compression
Printed in Switzerland • ISO to go ahead with guidelines for social responsibility
Cover photo : ISO 45 Coming up
ISO Focus July-August 2004
Comment
Preparing safety for all
S
afety in the workplace entails
a complex interaction – and
reaction – between the human,
machine and the work environment.
Not only is this concept important
to ensuring the safety and health of
employees, but it is the foundation
of the standardization process for
machine safety. The slogan “ Do it
once – do it right – do it interna-
tionally ” has in this instance to be
complemented by “ Do it right from
the beginning ” – meaning that the
concept of safety must be integrated
into the machinery at the design
stage. The result of this slogan saves
companies both time and money and,
at the same time, ensures employees
the safety and comfort of a worker-
friendly environment.
In order to implement a sys-
temic approach to standardization
in machine safety, a standardization
concept with horizontal and verti-
cal standards is needed to help the
designer with the methodology or giv-
ing decision guidance for designing a
safe machine. While horizontal stan-
dards describe the safety philosophy
and methodology, verticial standards,
on the other hand, are intended for
specific safety aspects such as safety
distances, general noise aspects and
application of ergonomic principles,
or products that can be used in dif-
ferent machines, e.g. safe control
systems, two-hand control systems,
and interlocking devices.
Internationally, work began
when ISO technical committee
ISO/TC 199, Safety of machinery,
was created in 1991 upon the initia-
tive of the European Committee for
Standardization (CEN), represented
by Paul Makin, who became its first
chair.
It is to his credit that the
horizontal European standards were
developed as ISO technical reports
and subsequently became ISO stan-
dards. Thanks to that, international of our working groups has prepared a
work on safety of machinery is known draft to be circulated soon for inquiry
in an increasing number of countries within the technical committee.
and becoming ever more important
internationally. The coming decade will be
dedicated to the revision of all other
ISO/TC 199 standards, meaning that
“ Safety must be they will gain further international
integrated into acceptance but maintain at the same
time their function within European
the machinery legislation. This will be a consider-
at the design stage.” able challenge for the experts in the
coming years.
By standardizing “ best prac-
tice ” at the international level, we
are certain to eliminate the technical
barriers to trade while maintaining the
safety and health of users of machin-
ery. That level of safety needs to be
high to be in line with the occupa-
tional health and safety requirements
of national legislations of different
countries around the world.
Where do we go from here ?
The next decade will call for the revi-
sion of the standards to improve the
interface between new emerging tech-
nologies and new ways of perceiving
machine safety. EN 292 parts 1 and Alfred Sutter
2 have been successfully revised Chair ISO/TC 199,
in 2004 as ISO 12100, Safety of Safety of machinery
machinery – Basic concepts, general
principles for design – Part 1 : Basic
terminology, methodology, and Part 2:
Technical principles.
Currently ISO 14121, Prin-
ciples of Risk Assessment, is in the
process of revision. Alongside ISO
12100, this standard has gained wide
acceptance. Many users regretted that
it did not provide specific tools to car-
ry out risk assessment, so that, due to
the need to adapt the standard to the
new ISO 12100, a revision of ISO
14121 became necessary.
Another important issue of
the machinery safety concept is
“ information for use ” : instructions
for users are an important element in
ensuring the safety of machinery. One
ISO Focus July-August 2004 1
World Scene
Standing up for the
global economy
More than 800 leaders of gov-
ernment and business from 70
countries gathered on the occa-
sion of the International Cham-
ber of Commerce (ICC) 35 th
World Congress, from 6 to 9
June in Marrakesh, Morocco,
to address the key challenges
facing business today while
highlighting the ICC tools
available to tackle them and
ICC commission work being
done to address them.
Jean-René Fourtou (below),
the Chief Executive of Vivendi
Universal and the Chair of the
ICC, issued the “ Marrakesh
Business Declaration ” urging
progress in the world trade
talks and strongly supporting
globalization.
One part of the declaration
says, “ There is an evident need
today for heightened security
measures for the movement of
goods and people across borders.”
It also said, “ But those measures
must be cost-effective and pose
the minimum of hindrance to
international commercial flows.”
One area of security that drew
attention was the International
Ship and Port Facility Security
Code (ISPS Code) that took
effect 1 July 2004, aimed at
securing maritime transport.
For more information:
http://iccworldcongress.net/
Ministerial Conference on
small businesses and
entrepreneurship
Ministers and government
representatives of more than 70
countries issued a common
declaration in Istanbul on 5
June 2004 at the close of the
2 nd OECD Ministerial Confer-
2 ISO Focus July-August 2004
ence on Promoting Entrepre-
neurship and Innovative SMEs
in a Global Economy.
The Ministerial Conference,
which was organized jointly by
the OECD (Organisation for
Economic Co-operation and
Development) and the Turkish
Ministry of Industry and Trade,
approved the Istanbul Ministe-
rial Declaration, and commit-
ted to, “ Working cooperatively
to achieve progress in reducing
barriers to SMEs’ access to
international markets.”
The event builds on the first
OECD ministerial conference
in Bologna, Italy, in 2000, at
which 48 countries adopted
the Bologna Charter on SME
Policies. The Charter established
the International Network for
SME’s (INSME), today an
association of over 40 countries
to promote innovation and
technology transfer among
small businesses.
For more information :
www.oecd.org
2005 World Sustainable
Building Conference
in Tokyo
Some 1500 building research-
ers, practitioners, officials,
industry representatives and
students from all over the
world will gather for the World
Sustainable Building Confer-
ence in Tokyo, Japan on 27
and 28 September 2005 to
exchange the latest knowledge
and experience on sustainable
buildings.
Its slogan “ Action for Sustain-
ability ” recognizes that now is
the time to move into action
towards the common goal of
providing buildings and an
urban context that support
sustainable ways of living.
Towards this end, the confer-
ence will focus on how to
bridge the gaps between envi-
ronmental, social and economic
aspects, gaps between the stake-
holder’s concerns and gaps
between the regional concerns.
Abstracts of 500 words or less
are being accepted until 1 Sep-
tember 2004.
This is the fourth event in the
series of international conferenc-
es, which is now seen as the pre-
mier international event in the
field of Sustainable Buildings.
For more information visit
the SB05Tokyo Website :
www.sb05.com/
or the SB05Tokyo Conference
Secretariat : info@sb05.com
International Conference
on “ Standardization-
Awareness-Compliance ”
Leaders from industry, govern-
ment, standards user organiza-
tions and standards developing
organizations will gather for
the 11th International Federation
of Standards Users (IFAN)
International Conference in
Amsterdam, The Netherlands,
on 11 to 12 November 2004.
The Conference will review ini-
tiatives from around the world
aiming to raise awareness of
standards and the standards
development process and the
relationships between regula-
tions, compliance and standards.
An audience of around 300
participants is expected to
attend the event which will
feature presentations by ISO
Vice-President (Policy), Dr.
Torsten Bahke, and other
prominent figures in interna-
tional standardization.
The event is being organized by
IFAN, in cooperation with the
Netherlands Standardization
Institute (NEN), ISO member
for The Netherlands and NKN,
the Dutch national IFAN
member.
ISO’s Committee on conformity
assessment is holding its plenary
meeting on 9 and 10 November
in Amsterdam in order to facili-
tate participation in both events.
For more information :
www.ifan2004.com
Workshop spurs
standardization activities
in African Union
A new momentum has been
created for the effective
coordination of standardization
activities in Africa by a recently
concluded workshop.
The African Regional Organiza-
tion for Standardization
(ARSO) and the African Union
(AU) organized the two-day
workshop on 24 and 25 May in
Kigali, Rwanda, to raise aware-
ness on standardization and to
highlight the needs to coordi-
nate standardization activities
in Africa, with a view at estab-
lishing an African Common
Market. Presentations included
a report by Mr. Asraf Caunhye,
Director of the Mauritius Stand-
ards Bureau and ISO Regional
Liaison Officer for Africa, on
collaboration between ISO and
ARSO.
Among the recommendations to
emerge were the need to encour-
age country membership and
participation in ARSO, its activi-
ties and in international stand-
ardization as well as to apply the
principles of harmonization of
standards as laid down in the
WTO’s Agreement on Technical
Barriers to Trade and the WTO’s
Agreement on the Application of
Sanitary and Phytosanitary
Measures.
The African Union meeting of
experts endorsed the recommen-
dations and agreed to forward
them for consideration by the
African Union Conference of
Ministers of Trade and Industry
for ratification and eventual
implementation within the rules
and procedures of the African
Union.
ISO Scene
ISO President’s official
visit to Poland
ISO President Oliver Smoot paid
an official visit to Poland in May
2004 as guest of the national
standards institute, Polish Com-
mittee for Standardization (PKN),
ISO member for the country.
ISO President Oliver Smoot
with Mrs. Smoot (centre) with
the President of PKN,
Dr. Janusz Szymanski (far right)
and the President of the Polish
Confederation of Employers,
Dr. Andrzej Malinowski (far left).
In addition to his discussions
with the President of PKN Dr.
Janusz Szymański, Mr. Smoot’s
schedule of VIP meetings
included a visit with the Presi-
dent of the Polish Bank Associ-
ation, the President of the
Polish Chamber of Commerce
and the President of the Polish
Confederation of Employers.
He underlined the increasing
need for and expectations placed
on International Standards to sup-
port a sustainable global econo-
my, with particular emphasis on
their significant contribution to
facilitating international trade.
PKN has been a member of ISO
since 1947 and currently partici-
pates in 272 of ISO’s standards-
developing technical committees
and subcommittees, which rep-
resents about 40 % of the total.
For more information :
www.pkn.pl
ISO Secretary-General on
official visit to Kazakhstan
ISO Secretary-General Alan
Bryden met the Prime Minister
of Kazakhstan, Mr. Akhmietov,
and the Minister for Industry and
Trade, Mr. Zhaksybekov, during
a visit to the country in late May
to participate in the 25 th session
of the Euro-Asian Council for
Standardization, Metrology and
Certification (EASC), attended
ISO Secretary-General Alan
Bryden with the Prime Minister of
Kazakhstan, Mr. Akhmietov.
by the representatives of 14
countries of the region.
Mr. Bryden spoke on Interna-
tional Standards in the global
economy and gave a press con-
ference in the company of Mr.
Kussainov, EASC Chairman
and President of KAZMEMST,
Kazakhstan’s Committee for
Standardization, Metrology and
Certification and ISO’s member
for the country since 1994.
Mr. Bryden encouraged the
public authorities and all other
economic actors to increase
their participation in interna-
tional standardization. He
welcomed Kazakhstan’s current
projects to adjust its legal
framework for technical
regulations, as well as to build
up its infrastructure and
increase initiatives to promote
quality in industry and services.
At the EASC meeting, Mr.
Sergiu Baban, General Director
of the Department of Standardi-
zation and Metrology in the
Republic of Moldova, was elect-
ed the new President of EASC.
Standards Norway
A new standards body has been
established in Norway following
the reorganization of the stand-
ardization system in the country.
Standards Norway (SN) takes
over all responsibilities in
regard to ISO which were pre-
viously held by the Norges
Standardiseringsforbund (NSF).
In accordance with this change,
ISO membership for Norway
has been transferred to SN from
NSF as of 1 June 2004.
For more information :
www.standard.no
Pan American Standards
Commission’s General
Assembly
An overwhelming majority of
delegates attending the Pan
American Standards Commission
General Assembly (COPANT
GA) prefer to enhance participa-
tion in ISO and IEC rather than
create a new set of regional
standards, according to ISO Vice-
President (technical) Ziva Patir.
The COPANT GA and related
meetings were hosted by the
Associação Brasileira de Normas
Técnicas (ABNT), ISO member
for Brazil, in Salvador de Bahia,
from 10 to 14 May 2004.
Ziva Patir, ISO Vice-President
(technical) gives a presentation at
the COPANT General Assembly.
Ms. Patir noted the increasing
number of COPANT members
interested in adopting ISO stand-
ards and translating them into
Portuguese and Spanish in an
effort to avoid duplication and
unnecessary barriers to trade.
Great interest in standards for
social responsibility was revealed
at a CSR seminar held in
conjunction with the COPANT
General Assembly, particularly
from developing countries that
believe they stand to gain from
any ISO activity in the area.
Carlos Santos Amorim of
ABNT was designated the
President-Elect of COPANT.
Pacific Area Standards
Congress
The 27 th meeting of the Pacific
Area Standards Congress (PASC),
a forum to strengthen international
standardization programmes for
countries in the Asia-Pacific
region, was held in Vancouver,
Canada in May 2004.
Presentations included a report
from ISO President Oliver
Smoot, on the impact of Inter-
national Standards and global
trade on national and regional
standardization.
The meeting agenda was high-
lighted by two workshop ses-
sions : “ the Roles of Standards
and Conformity Assessment to
support Good Regulatory Prac-
tice ” and “ Mentoring & Twin-
ning Arrangements ”. A tribute
was made to Peter Walsh of
Standards Australia Internation-
al (SAI), who will be leaving
the organization after some 30
years experience, for his service
and contributions to PASC.
The meeting was hosted by
SCC, the Standards Council of
Canada, ISO member for the
country.
ISO participates in 5 th
International Conference
on Performance-Based
Codes and Fire Safety
Design Methods
ISO’s technical
committee on fire
safety engineering
(TC 92/SC 4) is par-
ticipating in the 5th
International Con-
ference on Perform-
ance-Based Codes
and Fire Safety
Design Methods
which will present
the state-of-the-art
and case studies in this matter.
Due in part to the contribution
of ISO/TC 92, a growing
library of fire safety engineer-
ing design methods is available
to support these existing and
emerging performance-based
codes. An understanding of the
role of underpinning research,
engineering education and the
evolution process from pre-
scriptive to performance basis
is a key to successful imple-
mentation.
The conference, organized by
the Society of Fire Protection
Engineers, in collaboration with
CIB, IFE and IRCC will take
place on 6-8 October 2004 in
the European Commission
facilities in Luxembourg.
For more information :
www.sfpe.org
ISO Focus July-August 2004 3
Guest View
Hartmut Reuter
H
artmut Reuter is Chief
Executive Officer of the
Rieter Group, Winterthur,
Switzerland, since May 2002. After
studying industrial engineering
at Darmstadt University of
Technology, Germany, specializing
in electrical engineering, he
graduated in 1981. He has been
with Rieter Holding Ltd., Winter-
thur, Switzerland, since July 1997.
Most of his previous career was
with Robert Bosch GmbH, Stutt-
gart, Germany, between 1981 and
1997. He lives in Birchwil, in the
canton of Zurich, Switzerland.
ISO Focus : With a workforce of
13 000 employees at 60 locations
worldwide, the Rieter Group plays a
leading role both in textile machinery
manufacturing and as a supplier to
the international automotive industry.
Before we turn our attention to Inter-
national Standards, could you please
describe the businesses of Rieter and
how they interrelate?
Hartmut Reuter : Rieter, established
in Winterthur in 1795, is a Swiss-
based group operating on a global
scale in two industrial sectors, namely
textile machinery and automotive sup-
ply. In both of these fields the group is
a world market leader in the segments
covered. Worldwide sales in 2003
increased by 4 % to 3,12 billion CHF,
while 13 % of its approximately 13 000
employees work in Switzerland. Riet-
er Textile Systems Systems is well
known for its spinning machines pro-
ducing yarn out of cotton or man-made
fibers and for its equipment for the
production of nonwovens. Rieter Auto-
motive Systems develops and produces
components and systems for acoustical
comfort such as carpets, headliners and
parcel shelves and dampers.
4 ISO Focus July-August 2004
“ If the industry concerned
did not participate
there would be a danger
of too many theoretical
standards being issued
that bore little relation
to industrial reality.”
ISO Focus : Rieter employees actively
participate in ISO technical commit-
tee ISO/TC 72, Textile machinery,
and its subcommittees. What are
some of the advantages that partici-
pation in ISO’s technical work brings
to Rieter specifically, and to business
in general ?
Hartmut Reuter : International stan-
dards, whether in the field of product
safety, for example, or in quality
and environmental management, are
appropriate and useful at all events.
This is especially true for companies
like Rieter with an international scope,
which operate in a complex network
of suppliers, customers and joint ven-
ture partners. We actively participate
in ISO working groups so that not
only standards that impose restric-
tions on industry are developed, but
also those that assist industry and
make its work easier. If the industry
concerned did not participate there
would be a danger of too many
theoretical standards being issued
that bore little relation to industrial
reality. We are interested in contrib-
uting our experience to the process
of drawing up standards and in
being acquainted with standards at
an early stage so that we can start
to put them into practice properly
and without being under pressure
in terms of time. Participation by
the industrial companies that are
to implement these standards also
prevents unnecessary over-regulation
through standards. Overall, standard-
ization should help us to reduce costs
and increase our competitiveness.
ISO Focus : Offering state-of-the-art
manufacturing services in Europe,
South America, or China requires
International Standards for maintain-
ing industrial production from techni-
cal drawings, graphic symbols and
testing aspects to the intricate flow of
standard interchangeable parts.
How have ISO International Stan-
dards helped ? What specific stan-
dards would you like to see coming
out of ISO?
Hartmut Reuter : As CEO I am not
involved in every detail of these stan-
dards. Our quality managers confirm
that ISO standards are internationally
accepted, but also that their numbering
is rather complex. It’s difficult to get
a clear overall picture. The rather high
cost of copies also often means that
the standards are not available every-
where. Our quality managers have also
pointed out to me that many standards
in the field of simplified drawing are
only obtainable as DIN or at best EN
standards. ISO coverage of product
 All photos © Rieter

through our Rieter department for

Environment, Health and Safety (EHS)
The Rieter Group at the international level with meetings
and regular exchanges of experiences
Rieter, established in Winterthur in 1795, is a Swiss-based industrial group so that all Rieter locations worldwide
operating on a global scale. It is a leading supplier of systems solutions and maintain the same standards. Safety
services for the textile, automotive and plastics industries. provisions encompass personnel, the
Rieter Textile Systems develops and produces machinery, integrated systems industrial production processes and
PSAand technology
Peugeot components
Citroën, Direction for converting fibers and plastics into yarns,
de la Communication the products manufactured by Rieter.
nonwovens and pellets. In partnership with automotive manufacturers, Rieter In-house and external specialists regu-
Automotive Systems develops and produces components, modules and inte- larly inspect Rieter’s plants for compli-
grated systems on the basis of fibers, plastics and metals in order to provide ance with legal requirements as well as
acoustic comfort and thermal insulation in motor vehicles. internal and ISO standards. For safety
and health, local laws and regulations
are often more important than ISO
standards.
safety is also less than complete : CE
conformity in Europe versus CCC
conformity in China. In our view ISO
should prevent national standards from
becoming a barrier to trade through the
medium of safety regulations.

ISO Focus : On-the-job accidents and

illnesses can cause higher absentee-
ism and more downtime – and impact
the company’s bottom line. What
strategies does Rieter implement in
order to ensure the safety and health
of its workers ? How do ISO voluntary
standards help in this endeavour ?
Hartmut Reuter : We are convinced
that safety standards are very impor- Process control in Rieter’s
tant, and make workplaces safer technology center for
man-made fiber machinery.
(e.g. CE conformity of machinery
and tools). We coordinate our efforts

ISO Focus : What standards are of

value to Rieter in terms of quality and
environmental management ?
Hartmut Reuter : These are pri-
marily ISO 9001, ISO 9004 and
ISO 14001. In the Rieter Automotive
Systems Division, another 12 plants
obtained initial certification for com-
pliance with ISO 14001 in 2003, so
that more than 75 % of Automotive
Rieter Automotive’s Center of Excellence for acoustics Systems’ locations worldwide are
research (systems for acoustic comfort and thermal already certified under this standard.
protection in motor vehicles). Rieter Automotive has launched the
so-called ECO WAY environmental
ISO Focus July-August 2004 5
Guest View
programme that focuses on three
main issues : 1) eco-efficient prod-
ucts to minimize environmental
impacts throughout the product life
cycle ; 2) eco-efficient technologies
to reduce energy consumption, use
secondary raw materials and gener-

Measuring a Rieter interior carpet in the acoustic roller

test bench of Rieter Automotive Systems.

ate less waste ; 3) eco-efficient plants
to achieve superior production pro-
cedures.
ISO Focus : Companies will grow
and prosper when they compete on
the basis of quality, service, and inno-
Assembly of a vation. What are your views on the
combing machine in respective merits of supplier’s dec-
Rieter’s textile machinery laration and third-party conformity
production plant. assessment ?
Hartmut Reuter : The pressure
imposed by ISO 9001 certification
“ For safety and health, helps us to ensure that our suppliers
local laws and regulations worldwide improve their quality on
are often more important the basis of a uniform and traceable
system. Another advantage of certified
than ISO standards.” companies is that they always have
a competent contact point for qual-
ity, safety and environmental issues.
However, successful re-certification
after three years provides the first reli-
able evidence, since initial certification
can only be regarded as a beginning, a
first step. Nevertheless, we should not
forget that ISO certification is certainly
an important criterion but that cost and
flexibility are also important.
Interior noise measurement on the acoustic
roller test bench of the Swiss supplier Rieter
Automotive Systems.

6 ISO Focus July-August 2004

 Main Focus
Safe machinery
Photo © ISO
saves lives
Copyright BP Plc.
Putting machine
safety in a global
perspective
By Jean Bataillé, Convenor
ISO/TC 199, Safety of machinery,
WG 1, Basic principles,
methodology, terminology
W
hen, in November 1995, the
CEN/TC 114 Special Group
undertook to revise ISO/TR
12100 1) (the ISO Technical Report
endorsing the basic European stand-
ard linked to European regulations:
EN 292:1991) within the framework
of the Vienna agreement, the mem-
bers of the group decided from the
outset that the standard resulting from
this revision would be a fully-fledged
International Standard, both in con-
tent and in form. Thanks, therefore,
to the participation of experts from a
wide range of horizons – whether in
terms of countries or in terms of the
interests they represented – this risky
undertaking was brought to comple-
tion. After eight years of intense activ-
ity (November 1995-November 2003),
this important “ core ” standard for the
field of machine safety saw the light
of day.
The remarkable determina-
tion of the Special Group, which did
not hesitate to meet five times in the
course of 2001 alone to deal with all
the comments returned on the DIS
(draft International Standard), deserves
to be underlined. The only blemish in
the process was due to a peculiarity
in the implementation of the Vienna
Agreement (now corrected), which
unfortunately prevented unanimous
adoption by the 23 Participating mem-
bers of ISO/TC 199.
Promoting the concept
of integrated safety
When the designer of a
machine does everything in his power
to ensure that the user of the machine
has nothing more to do, to work safely,
than to stay within the boundaries of
the normal anticipated use, then he is
integrating safety into the design of
this machine.
As yet, the principle of inte-
grated safety is not universally applied
and was therefore hotly debated before
1) ISO/TR 12100, Safety of machinery – Basic
concepts, general principles for design – Part 1:
Basic terminology, methodology and Part 2: Tech-
nical principles.
ISO Focus July-August 2004 7
Main Focus
the group members finally agreed on
the fact that the more upstream the pro-
tective measures are applied, the more
effective, safe and even cost-effective
they are.
A well established risk
reduction strategy
ISO 12100 advocates an itera-
tive method (involving a succession of
“ loops ”) for reducing risk at the design
stage; according to this method, the
integrated protective measures applied
during each “ loop ” result from an
initial assessment of the risk, and their
effect is evaluated on the basis not only
of the achieved reduction in risk, but
also of elements such as the non-intro-
duction of new risks, the preservation
of the machine’s ability to perform its
function, the preservation of the opera-
tor’s working conditions and those
of other people involved (concept of
adequate risk reduction).
This “ 3-step ” iterative method
requires the designer to take full advan-
tage, in turn, of inherently safe design
measures, safeguarding measures and,
finally, user information measures
aimed at providing the latter with all
he needs to know to take the protective
measures relevant to his field.
8 ISO Focus July-August 2004
Finally, in Part 2, ISO 12100
describes a number of general princi-
ples for the implementation of each
Photo © Yves Cousson/INRS
of the three steps of the risk reduction
method (inherently safe design, safe-
guarding, information for use).
A broad range of users
One important element of this A careful reading of the two
strategy lies in the method used to parts of the standard shows that it does
evaluate – by answering a set of nine indeed apply to all machines : conven-
questions – whether the risk reduction tional machine tools, mobile machines,
objectives have been achieved. lifting machines, machines intended
for the general public.
ISO 12100 is primarily intend-
Terminology, basic hazards, ed for designers of machines – all
and principles for design machines – particularly when there are
Before describing the “ 3-step ”
method, ISO 12100 defines 54 terms “ ISO 12100 defines
ranging from “ machine ” to “ protective the basis on which all
measures ” and from “ safety function ”
to “ failure to danger ”. This terminolo-
international Standards
gy will serve as a basis for an interna- devoted to machinery
tional multilingual glossary of machine safety should be built
safety.
The standard also gives a descrip-
to meet the criterion of
tion of basic hazards to be taken into worldwide relevance.”
account in the design of machines, a
description which is particularly useful in
connection with the initial risk analysis, About the author
which is one of the preconditions to the
implementation of the “ 3-step ” method. Jean Bataillé
was in charge
of conformity
to standards
and regulations,
applicable in
France, and of
the exports of
handheld elec-
trical tools at
Black & Decker, and subsequently at
Peugeot Outillage Électrique. In 1988,
he joined the Union de Normalisation
de la Mécanique (French standardiza-
tion bureau for mechanical engineer-
ing) and takes an active part in CEN/
TC 114, Safety of machinery, and in
ISO/TC 199. Jean Bataillé joined the
Photo © Yves Cousson/INRS
Mission Normalisation in Institut
National de Recherche et Sécurité
(French occupational health and safety
institute) in 2001 and increased his
involvement in the standardization of
machinery safety.
 Safe machinery
saves lives
no specific standards dealing with the
machine in question (product safety
standard, or Type C standard according
to the definition given in ISO/IEC 51 ;
Type C standards are product standards
that contain detailed specifications
for particular machines or groups of
machines). It is also intended as a help
to writers of Type C standards and is in
fact aimed at all social and economic
players involved in machine safety.
Considering the nature of its provi-
sions, the standard is also intended
for those who train designers (students
or engineers). In its introduction, the
standard states : “ It is recommended
that this standard be incorporated in
training courses and manuals to convey
basic terminology and general design
methods to designers .” The training of
designers is a form of advanced protec-
tion which cannot but have a positive
impact on both society and the econo-
my. Steps to that end have already been Safety pays :
taken in many countries to approach
those involved in further training as
designing
well as initial training. machines that care

A special place among
other standards
The content and scope of ISO
12100 – “ 3-step ” method, description
of basic hazards, general design princi-
ples applicable to all machines (indus-
trial machines, mobile machines, lifting
appliances, etc.), the representativeness
By Paul Makin, immediate past
chair, ISO/TC 199, Safety of
machinery, Chester, United
Kingdom
Photo © ISO
individual machine are the same – or
at least similar – wherever it is used.
It is therefore logical to expect that
there should exist the possibility of
developing a common approach – a
common philosophy and methodology

of the experts within the Special Group
(representatives of machinery manu-
facturers and users, consumer asso-
ciations, occupational safety and health
experts and public authorities), but
also the quadripartite ISO/IEC/CEN/
CENELEC representation, the partici-
pation of the membership of technical
committee ISO/TC 199, Safety of
machinery, representing all continents
– all of these elements lend support
to the claim that ISO 12100 defines
the basis on which all International
Standards devoted to machinery safety
should be built to meet the criterion of
worldwide relevance.
T
he increased use of machinery
is one of the key stages in the
development of any country,
and there is now a wide spectrum
of use from the mature societies in
the developed world to those in the
emerging economies. Today, machines
are used for both professional use in
such key sectors as metal and wood
working, plastics and paper, construc-
tion, agriculture and forestry as well as
non-professional use in the home and
garden and leisure. Indeed, a growing
trend is the migration of machines
intended for professional use into the
non-professional sector.
However, while the inten-
sity and range of use may vary from
country to country and industry to
industry, the risks from the use of an
– to reducing the risks arising from the
use of machinery that could be applied
anywhere in the world.
Historically, national laws and
regulations dealing with the safety of
machines have developed in parallel
with the increased use of machines in
response to society’s need to have the
benefits from the machines without the
consequential costs from the risks that
machines generate. Individual countries
have developed their own approach to
machinery safety legislation and many of
these sometimes conflicting approaches
have in effect been seen or are barri-
ers to a truly global trade in machines.
Manufacturers have had – and still are
having – to produce machines with
different protective measures to gain
access to different markets.
ISO Focus July-August 2004 9
Main Focus
How a common philosophy
and methodology can help
The use of a common philoso-
phy and methodology that can be used
for any machine and for any risk or
combination of risks will :
Photo © New Holland
• Allow product standards to be
developed within ISO and IEC
that are based on an internationally
accepted approach.
• Stimulate the development of
protective devices as technology
develops.
• Promote a constructive dialogue
between the developed and devel-
oping countries.
• Allow a wide range of interests
such as consumer groups and
employee representatives to take
part in the future development of
the philosophy and methodology.
• Contribute towards the develop-
ment of an international machinery
market through the abolition of
technical barriers to trade.
• Reduce the risks of injury at home,
work and leisure.
• Contribute towards the achieve-
ment of equal levels of safety in the
various countries for each safety
aspect dealt with in a standard.
• Stimulate the development of
protective devices as technology
develops.
• Promote a constructive dialogue
between the developed and devel-
oping countries.
10 ISO Focus July-August 2004
• Facilitate relations between manu-
facturers, users and bodies in
charge of technical inspection and
testing.
• Promote the risk-based approach to
machinery design.
This approach, as encapsulated
in ISO 12100, Safety of machinery
– Basic concepts, general principles
for design – Part 1: Basic terminology,
methodology and Part 2 : Technical
principles, gives special benefits to
SMEs that may not have the resources
to develop their own approach to many
sophisticated areas of technology.
They can also use the standards with
the confidence that they are using the
methodology that has been developed
by the world’s leading experts in the
given technology.
My views
on the current situation
in standards bodies
Nearly everyone involved in the
production of safety standards agree
that the future lies in making stand-
ards at the international level : “ do it
once, do it internationally ”. This is
reflected within CEN and CENELEC
where most new work and revisions of
existing standards are planned as ISO
or IEC standards under the cooperative
agreements (Vienna Agreement and
Dresden Agreement) with CEN and
CENELEC.
“ The risks from the use
of an individual machine
are the same – or at
least similar – wherever
it is used.”
However, in my view, it would
be wrong to take the view that the future
is all bright for international standardi-
zation in the safety of machinery field.
There are some fundamental problems
that standards bodies and national gov-
ernments have to solve.
The first one is that to be truly
international the standards have to be
developed and accepted by all coun-
tries – and that is not the case at the
moment. Standardization both general-
ly and within the machinery sector is a
“ rich countries ” club. It requires a well
developed national standards structure
to participate at the ISO/IEC level. It
also requires national organizations
that are prepared to send experts to the
meetings – which are almost inevitably
somewhere else in the world. These
requirements exclude most developing
countries that do not have the neces-
sary resources in money and expertise.
Lest we are too complacent, let us
also understand that within Europe
many interest groups are also excluded
from the standardization process. For
About the author
Paul Makin
was chair of
ISO/TC 199,
Safety of
Machinery
from its incep-
tion in 1991
until 2002, and
was chair of
the ISO/IEC
group that produced ISO/IEC Guide
51:1999, Safety. A professional
mechanical engineer by training, he
was employed as an engineering man-
ager in the senior management teams
of various companies and was one of
the UK’s Inspectors of Health and
Safety in the Health and Safety Execu-
tive, heading machinery safety in the
Technology Division. He was head of
the BSI delegation to CEN during the
creation of the machinery safety pro-
gramme in support of the European
Machinery Directive. He was one of
the “ philosophers ” that wrote the
European standards, EN 292, Safety of
machinery. Paul Makin presently runs
his own consultancy providing advice
on machinery safety, standards and
European legislation.
 Safe machinery
saves lives
example, few working groups have an
input from workers’ representatives
or from consumer groups. The same
applies to SMEs – the very organiza-
tions expected to benefit from the new
standardization process.

Clash of legal systems

Another major problem is the
clash of national legal systems. This
has became very apparent within the
machinery sector over the so-called
“ list of hazards ”. Using the EN 292/
ISO 12100 approach, it is necessary to
produce a list of hazards being dealt
with within the standard. This is an
essential step – from the European
point of view – which defines the
basis of the risk assessment and the
consequent risk reduction measures.
However, from the American point of
view – or at least the American legal
profession – this is completely unac-
ceptable because it is considered to
be guilty knowledge and makes the focus of many institutions. This is not
machinery supplier vulnerable in the Universal and to suggest that the safety of machinery
event of a claim for damages. From
the European point of view, any stand-
individual risk was ignored or not considered earlier
during its evolution. It is the author’s
ard that gives risk reduction measures observation that safety of machinery
without defining the hazards that they has become its own discipline within
are aimed at is dangerously mislead- By Dennis R. Cloutier, Cloutier the past 60 to 70 years.
ing because it could be used to deal
Consulting Services, Cincinnati,
with the wrong mix of hazards. This
USA, US Delegate to How to address hazards
apparently simple difference is hold-
ing up the production of a wide range TC199/WG 5, Risk assessment present in the operation
of machinery standards. of machinery
The declaration by the World

Trade Organization that international
standards are an essential aid to a
truly global trade was encouraging.
However, the reality of the situation is
that there has been little or no positive
action to support the use of standards
to remove Technical Barriers to Trade
(TBTs). Perhaps we need to resolve
some of the problems within the stand-
ards organizations before this will
happen ?
There is also the need to speed
up the whole production process so
that the very scarce resources available
with the whole standardization field
are used to the best effect.
W
hen man first developed
implements to assist him
with obtaining the basic ele-
ments of life, he also introduced risk.
If a stick could be used as a club to
subdue large animals thus providing
food, the stick could also cause harm
to the user or other individuals.
Today we have advanced far
beyond using a stick as a club, and in
the process we have introduced unim-
aginable risk to all of society. A simple
examination of the machinery man has
invented over time, and especially in
the last century, would easily reveal
the hazards associated with its use.
Over the past several decades,
the safety of individuals operating and
maintaining machinery has become the
There are numerous products
that are used continuously, every day
by mankind to help us travel, com-
municate, manufacture items, prepare
our food and so on. In the International
Standards community, ISO/TC 199 is
concerned with the safety of machin-
ery. There are numerous standards
that address the safety of machinery
society uses on a daily basis. Many of
these standards include safety require-
ments applicable to specific machines.
There are some standards that address
the concept of safety, in general, as it
applies to the manufacture and use of
machinery. These address the hazards
present in the operation of machinery
and the risk of harm to those involved
in the operation or repair of the
ISO Focus July-August 2004 11
Main Focus
machinery. It naturally follows that
once risk is identified, measures are
implemented to reduce that risk.
The elements needed
for performing a risk
assessment
ISO 14121, Safety of machin-
ery – Principles of risk assessment,
was first developed using European
standard EN1050 as a model docu-
ment. Currently it is undergoing a
revision which will harmonize it with
other ISO standards that prescribe the
performance of a risk assessment and
risk reduction. TC 199/WG 5 has been
established to write the revision of ISO
14121. The working group currently is
midway through the project and it is
apparent the revised document will be
substantially more than the original.
Risk assessment is a process
that can be applied to any piece of
equipment, or process. It will help the
people performing the assessment to
identify hazards associated with the
machine or the process subject to the
assessment. With hazards identified,
risk can be evaluated and appropriate
protective measures can be selected
to reduce risk to some predetermined
level. However, while the process may
be considered universal, the applica-
tion to a particular type of equipment
may differ. The difficulty comes with
the nature of the equipment. That is, if
the equipment is a production machine,
operated in a controlled environment,
the assessment is different from if it is
a consumer product developed for pub-
lic use. Another difficulty comes from
considering who is performing the risk
assessment and the risk reduction.
The manufacturer (supplier) of equip-
ment must perform an assessment and
apply appropriate protective measures
because he knows best the details of
his equipment. As the manufacturer
gives the performance of his equip-
ment he has to guarantee its safe use.
However, because the focus of all this
is the reduction of harm to individuals
involved in the day to day operation or
maintenance of machinery, the user
(employer) should also be considered.
12 ISO Focus July-August 2004
Photo © A. Sutter, SUVA
To achieve maximum risk reduction,
he, too, must perform the risk assess-
ment and the risk reduction by taking
into account the instructions and infor-
mation for use of the manufacturer.
ISO 14121 is being revised
in order for it to harmonize with the
requirements of newly revised ISO
12100 (see p. 7). This revision of ISO
14121 provides the required elements
for performing a risk assessment and
how it should be organized. The sub-
jective nature of evaluating risk, deter-
mining the exposure to and severity of
that risk and estimating the probability
of a harmful event taking place leads
to several different methods to perform
risk assessment. This does not take
into account the selection of appropri-
ate protective measures, which must be
done to complete the process.
“ Our goal is the
elimination or reduction of
harm to individuals.”
Photo © A. Sutter, SUVA
Each task is evaluated
for possible hazards
The new draft includes an
extensive informative annex which
includes several examples of risk
assessment and risk reduction method-
ologies. The examples will include an
analysis at the design phase (without
protective measures), for the identifi-
cation of hazards, hazardous situations
and harmful events. Another example
will be a methodology utilizing a risk
matrix. This example uses a task-based
approach which begins by identifying
what individuals do when operating
or repairing a machine. Then each
task is evaluated for possible hazards,
resulting risk including exposure and
severity of harm. Finally, protective
measures are implemented to reduce
risk to a predetermined level. Another
example demonstrates the use of a
graph to lead the user through the proc-
ess. There are two similar examples
that use a numerical scoring system
and a “quantification” method to help
About the author
Dennis R.
Cloutier has
been President
since 2001 of
Cloutier Con-
sulting Services,
in Cincinnati,
USA, a technical
services compa-
ny, and has been
long involved in
safety consulting services, compliance
with regulations and standards, risk assess-
ment training, and is a presenter at educa-
tional forums. Between 1973 and 2001, he
was with Cincinnati Incorporated, first as a
factory service representative and then
safety coordinator for nearly 20 years.
He is a member of National Safety Council,
American Society of Safety Engineers, and
is ISO/TC 199/WG 5 representative for US
TAG, as well as chair of ANSI B11TR3
committee, Technical report on Risk
Assessment and Risk Reduction, and chair
of ANSI B11TR5 committee, Technical
report on the measurement of noise
generated by machinery.
 Safe machinery
saves lives
the individuals performing the assess-
ment through some of the subjective
aspects of the process. A review of the
examples may lead some to consider
the various attributes of the different
approaches and consider developing
their own. There will be an example of
a hybrid method to illustrate how this
can successfully be accomplished.

Attempting to unify the

process
There are many risk assess-
ments documents in place or under
development. Attempts have been
made, and continue to be considered to
Easy to operate :
unify the process and develop one uni-
versal risk assessment and risk reduc-
earth-moving machinery
tion guide. The difficulty the experts in
the field cite in this effort is the chal-
lenge presented by the varied nature of
risk and the different kinds of exposure
Photo © Caterpillar

for individuals. Consumer products are

very different from machine tools that
are provided for the manufacturing
environment. Individuals are exposed
to risks from all types of machines
with which they may interact through
the average day. The car, bus or train
they commute in, the building eleva-
tors or escalators they ride in or on, the
machines they operate or repair, and
everything else present numerous risks
as well as hazardous situations. The
subject is very broad and no expert or
committee of experts has yet been able
to address an issue of this scope with-
by Dan Roley, Chair of
ISO/TC 127, Earth-moving
machinery, and of ISO/TC
127/SC 2, Safety requirements and
human factors, Standards
Manager for Caterpillar
Corporate Standards and
Regulations Department, USA
provide a working environment for the
operator that is safe and comfortable,
with controls that are easy to operate.
By the 1960’s the earth-moving
machinery industry was already a global
industry, with machines from the USA,
Europe and Asia being sold into earth-
moving applications around the world.
Several countries were beginning to
develop standards and regulations for

E
out the project becoming too complex arth-moving machines are used
and the experts losing sight of the real for excavating, loading, trans-
goal. Remember, our goal is the elimi- porting, spreading, and com-
nation or reduction of harm to indi- pacting earth and other materials – see
viduals. So, individual risk assessment the examples of earth-moving machines
and risk reduction standards or guides on the following pages. They range in
will continue to be developed by the size from small machines that can drive
various industry sectors. This will through doorways to very large machines
result in specific rather than general that can be worth several million USD.
guidance, which will achieve greater Operating an earth-moving
reductions in harm to society. machine is similar to driving a car or
truck, except the operator must also
control the machine attachment or
work tool that moves the earth or other
material. The operator stations on
earth-moving machines are designed
to comply with the ISO/TC 127/SC
2 safety and ergonomics standards to
earth-moving machines, which created
a challenge for the industry to be able
to meet the different requirements in
different countries.
“ Adopted as national
standards, ISO standards
have reduced the cost and
complexity of developing
and proving compliance
with the safety standards.”
To address the challenge of
having to comply with the different
requirements around the world,
ISO/TC 127 was formed in 1968
ISO Focus July-August 2004 13
Main Focus
to develop international standards
for earth-moving machinery. The
objective was to develop a complete
set of ISO standards that could be used
as the basis for any national standards
and regulations. Since 1968, over
100 ISO/TC 127 standards have been
published to address the commercial
needs for earth-moving machines and
the safety and ergonomics areas for
earth-moving machines. Twenty new
standard projects are underway to
address smaller, larger and new types
of machines and the application of new
technologies.
Addressing safety and
human factors
One common objective of
both the earth-moving machinery
industry and the users of earth-
moving machines is to provide a safe
and comfortable work place for the
workers who operate the machines.
This common objective has enabled
health and safety experts from
industry, relevant organizations and
independent test laboratories to work
together efficiently in ISO/TC 127/SC
2 to develop over 40 standards that
address the safety and human factors
14 ISO Focus July-August 2004
ergonomics standards by the USA and
Japan and have been referenced for the
technical requirements in the European
earth-moving machine standards. With
the adoption of the ISO standards as
national standards, the cost and com-
plexity of developing and proving
compliance with the safety standards
has been reduced and the overall level
of safety and comfort for the earth-
moving machinery industry has been
improved.
“ With ISO standards,
the overall level of safety
and comfort for the earth-
moving machinery industry
has been improved.”
Photo © Caterpillar
The ISO operator protection
standards are the best examples of
the ISO/TC 127/SC 2 safety standards
that have improved operator safety
areas of earth-moving machines. and that have significantly reduced
Representatives from 18 Participating the costs to market of machines glo-
member countries take part in ISO/TC bally. Industry performed extensive
127/SC 2. The combined input from testing and simulations of machine
all participants has been compiled into rollovers and intrusions into the
standards that cover safety areas such operator space to develop perform-
as the following : ance criteria for operator protections
Access systems • operator dimensions systems. These criteria were incorpo-
and space requirements • operator rated into ISO standards for rollover
protection systems • braking • visibility protection structures (ISO 3471), fall-
and mirrors • steering • controls • seats ing object protection structures (ISO
and seat belts • vibration • sound • safety 3449) and operator protection guards
signs • electrical and electronic systems (ISO 10262). The ISO/TC 127/SC 2
• warning alarms •
operator environment
• lighting • guarding
• operator instructions
• visual displays.
Photo © Caterpillar
ISO
standards
adopted and
referenced
worldwide
Most of the
ISO/TC 127/SC 2
safety and ergonom-
ics standards have
been adopted as
national safety and

Photo © Caterpillar
About the author
Dan Roley,
Chair of ISO/TC
127 and of TC
127/SC 2 is the
Standards Man-
ager for Cater-
pillar in the cor-
porate Standards
and Regulations
Department. His
first research
projects at Caterpillar were in the ergo-
nomics and whole body vibrations areas,
where he developed ergonomic guidelines
for earth-moving machines and provided
input for the ISO/TC 127 standards for
ergonomics and seat vibrations.
Dan Roley worked at the INRS Vibration
Laboratory in France as a participant in the
USA-France Exchange of Scientists
Program, following which he worked as
the Project Leader for the test and develop-
ment of new machines used for earth-
moving, agriculture and forestry. Mr.
Roley worked at the Caterpillar European
office in Geneva, Switzerland, as the Inter-
national Research Manager, then moving
to the Standards and Regulations Department.
operator protection standards have
been accepted by all countries, which
allow one design to be used around
the world. Since operator protection
structures are complex to design and
require costly destructive testing to
show compliance with the standards,
the internationally accepted standards
enable significant cost savings for
both industry and customers.
Several other ISO/TC 127/SC 2
standards have provided similar results
in improving safety and providing
performance criteria for effectively
addressing safety areas. Four good
examples of other ISO standards that
are internationally accepted and that
enable significant cost savings are
the standards for steering (ISO 5010),
electromagnetic compatibility (ISO
13766), visibility (ISO 5006) and brak-
ing (ISO 3450).
Manufacturers of earth-mov-
ing machines generally have incident
tracking systems that document any
safety incidents on their machines.
The information from the incident
tracking systems show that the ISO/
Safe machinery
saves lives
TC 127/SC 2 standards define safety
performance criteria that are effec-
tive.
While ISO/TC 127/SC 2 has
developed over 40 standards in its
attempt to develop a complete set of
safety and ergonomics standards, the
work in SC 2 is continuing to address
new types of machines and the new
technology. SC 2 has 22 active projects
to update the existing standards and
to develop new standards. Some
examples of new standards projects
include new standards for: electronic
control systems, hazard detection
systems, remote control of machines
and whole body vibrations.
Some examples of standard
update projects include: steering to
cover electronic steering, controls
standard to cover new types of multi-
function controls, excavator operator
protection standard to cover larger
excavators, EMC standard with more
stringent immunity requirements, and
roll-over protections standard to cover
nonmetallic components.
ISO Focus July-August 2004 15
Main Focus
Hazards are
everywhere:
how to achieve
functional
safety
By Mark Bowell, Specialist
inspector of control systems in
the United Kingdom Health and
Safety Executive
O
ur workplaces are full of
hazards (potential sources of
harm). To name but a few : a
guillotine on a paper-cutting machine
could slice off a worker’s hand, a
crane that is too overloaded will fail
mechanically, exothermic reactions in
a chemical plant could reach a runa-
way condition, hydrocarbons on an oil
refinery could leak and ignite, and the
dynamic positioning system of a ship
must continuously adjust the thrust-
ers correctly to avoid collision with a
nearby installation.
16 ISO Focus July-August 2004
Our first aim is always to elimi-
nate the hazards at source. This can be
achieved by the application of inherent
safety principles and good engineering
practice. However, in many industrial
scenarios it is not practicable to elim-
inate every hazard. For example, guil-
lotines need a sharp blade to cut paper,
an exothermic reaction may be the
only way to produce a particular chem-
ical, and oil refineries always contain
hydrocarbons.
Fortunately, these hazards very
rarely materialize because we design
control or protection systems to ensure
safety. These safety-related systems
defend against the remaining hazards
by monitoring the state of the proc-
ess under control and taking specif-
ic action to prevent an unsafe state
occurring. In many cases the specific
action is to shut down part or all of the
process being monitored. If there is no
simple safe state, such as with a ship’s
dynamic positioning system, the safe-
ty-related system will have to continu-
ously control the process.
Safety that depends on a control
or protection system operating cor-
rectly in response to its inputs is called
functional safety. Functional safety
Photo © ISO
is the topic of the IEC 61508 series,
which covers safety-related systems
that use electrical and/or electronic
and/or programmable electronic (E/E/
PE) technologies. The standard applies
to these systems irrespective of their
application and includes every part of
the system necessary for correct opera-
tion (not just the control logic).
About the author
Mark Bowell is
n expert sup-
orting the work
f IEC SC65A
Working Group
4 and the devel-
pment of the
EC Functional
afety Zone. He
as been a spe-
ialist inspector
of control systems in the UK Health and
Safety Executive since 1999. Before then,
he was a research scientist with the Health
and Safety Laboratory investigating soft-
ware engineering techniques for safety-
related systems. He has an MSc in Soft-
ware Engineering, is a Member of the IEE
(the Institution of Electrical Engineers) and
is a Chartered Engineer.

Example applications
and technologies
An example E/E/PE safety-
related system using electrical (or
electro-mechanical) technology is the
guard interlocking and emergency
stopping system for machinery.
Many safety-related systems
that would have used electrome-
chanical technology or solid-state
electronics now use programmable
electronics instead. Such devices
include programmable controllers,
programmable logic controllers and
digital communication systems (e.g.
bus systems). Enabling technologies
such as application-specific integrated
circuits, microprocessors, and intel-
ligent sensors, transmitters and actua-
tors, are increasingly being integrated
into products and systems.
Meeting the challenge
The challenge is to make sure
that our safety-related systems are suf-
ficiently reliable and carry out all the
functions we need. In practice, E/E/PE
safety-related systems are too complex
to fully determine every failure mode
or to test all possible behaviour. We
have to design each system in such
a way as to prevent dangerous fail-
ures or control them when they arise.
Dangerous failures may arise from
Safe machinery
saves lives
development of the safety require-
ments, specification, design and imple-
mentation, operation and maintenance,
and modification, to final decommis-
sioning and/or disposal. The standard
considers all parts of an E/E/PE safety-
related system that are necessary to
carry out the required functions (i.e.
from sensor, through control logic and
communication systems, to final actua-
tor, including any critical actions of a
human operator).

“ Recent developments
include network-based
safety-related systems,
facilitated by Internet
technology ”
Example applications include
crane safe load indicators, variable speed
motor drives used to restrict speed for
protection, systems for interlocking and
controlling the exposure dose of medical
radiotherapy machines, or the indicator
Photo © ISO

lights, anti-lock braking, and engine-

management systems on automobiles.
Other examples are emergency
shutdown systems in hazardous chemi-
cal plants, railway signalling systems
and fly-by-wire operation of aircraft
flight control surfaces.
Recent developments include
network-based safety-related systems,
often facilitated by Internet technol-
ogy, such as the remote monitoring,
operation or programming of a net-
work-enabled water treatment plant.
An E/E/PE system may be
safety-related even if it does not have
any direct control over potentially
hazardous equipment. For example,
an information-based decision support
tool might be safety-related if errone-
ous results compromise safety.
errors or omissions in the specifica-
tion, random failures of hardware due
to wear and tear, systematic failures
of hardware and/or software due to
design errors, human error, environ-
mental influences such as temperature
or electromagnetic interference, or
problems with the electrical supply.
IEC 61508 uses a risk-based
approach to determine what effort
should be spent on the design of the
E/E/PE safety-related system and to
quantify the required hardware reli-
ability. It covers all development
activities from initial concept, through
hazard analysis and risk assessment,
Hence, IEC 61508 aims to
release the potential of E/E/PE tech-
nology to improve both safety and
economic performance, and enable
future technological developments to
take place within an overall safety
framework. Users and regulators can
gain confidence where it has been
applied. It increases efficiency in the
supply chain for suppliers of subsys-
tems and components across indus-
trial sectors, improves communication,
increases clarity of what needs to be
specified, and enables the develop-
ment of conformity assessment serv-
ices if required.
ISO Focus July-August 2004 17
Main Focus

Photo © ISO
IEC basic safety
publications
Parts 1, 2, 3 and 4 of IEC 61508
are IEC basic safety publications. One
of the responsibilities of IEC technical
committees is, wherever practicable, to
make use of these parts of IEC 61508
while preparing their own sector or
product standards that have function-
al safety of any E/E/PE safety-related
systems within their scope.
Standards based on IEC 61508
have already been published for the
nuclear (IEC 61513) and process (IEC
61511 series) sectors. Other work in
development includes standards for
the machinery sector and for power
drive systems.
Sector specific standards based
on IEC 61508 are aimed at system
designers, system integrators and users.
They take account of specific sector
practice, which can allow less complex
requirements, they use sector terminol-
ogy to increase clarity, and may spec-
ify particular constraints appropriate
for the sector. Usually the sector spe-
cific standard will rely on the require-
ments of IEC 61508 for detailed design
of subsystems, but they may allow end
users to achieve functional safety with-
out having to consider IEC 61508 them-
selves.
All parts of IEC 61508 can Vibration and in the development of our standards.
Simply put, these standards can lite-
be used directly by industry as a set
of general requirements for E/E/PE
shock affect rally affect peoples’ lives, livelihoods
and quality of life.
safety-related systems where no appli- peoples’ lives The general science behind
cation sector or product standards exist these standards covers the broad
or where they are not appropriate. IEC areas of biodynamics, structural
61508 is also used by suppliers of E/ dynamics, rotor dynamics, structural
E/PE components and subsystems for By Bruce Douglas, Chair acoustics (in concert with ISO/TC 43,
use in all sectors. Acoustics), signal processing and the
ISO/TC 108, Mechanical
The IEC web site has a condition monitoring of structures and
Functional Safety Zone (www.iec.ch/
vibration and shock, and machines. These sciences are complex
functionalsafety) giving further details Eberhard Christ, Chair ISO/TC in their own right and many are in the
of the IEC 61508 series and associated 108/SC 4, Human exposure to early stages of evolution. All directly
standards. This includes an extensive mechanical vibration and shock impact workplace safety by providing
set of frequently asked questions. If guidance to establishing either :

I
you cannot find the information you n ISO/TC 108, Mechanical vibra- • human exposure limits ;
are looking for, you can submit a new tion and shock, we take the devel-
opment of mechanical vibration • methods to evaluate, assess and
question for consideration by the com-
and shock standards for workplace monitor the overall dynamic work-
mittee responsible for guidance on the
safety very seriously. This responsi- place environment i.e. assess risk ;
standard.
bility, along with the effects of vibra- • methods to identify, diagnose and
tion and shock on public safety and the prognosticate specific potential
environment, is a paramount concern workplace hazards ; and
18 ISO Focus July-August 2004

• methods to identify appropriate
cost-effective corrective action to
mitigate potential workplace haz-
ards.
Assessing the nature of
dynamic forces at work
When assessing the effects on
vibration and shock on workplace
safety, the first consideration is the
nature of dynamic forces at work.
They vary widely from steady state
vibration to low range impulsive forces
to high level shock, and each requires
different methodology, monitoring
cycles and assessment tools.
The general scope of ISO/TC
108 covers the broad area of mechanical
vibration and shock and their effects on
1 – Cracked Power Plant Rotor.
2 – Whole-body vibration exposure at work
with a wheel-loader.
3 – Hand-arm vibration exposure at work with
an angle grinder.
Safe machinery
saves lives
humans, machines, vehicles and struc-
tures, all factors in workplace safety.
More specifically, its scope includes the
general areas of mechanical vibration
and shock pertaining to : terminology
and nomenclature ; actuators, sensors
and associated signal analysis instru-
mentation ; vibration and shock reduc-
tion and control methods ; and, finally,
the measurement and evaluation of the
exposure of humans, stationary structu-
res, vehicles and machines. In addition,
standard methods of data processing,
data acquisition, diagnostic measure-
ment methods, transducer calibration
and condition monitoring of machines
and structures are actively being deve-
loped. All these subjects are related to
workplace safety either directly through
assessment of human exposure, poten-
tial workplace hazards and application
of hazard control or indirectly by diag-
nosing and predicting future workplace
hazards.

“ Human exposure to
whole-body vibration is a
widespread occupational
factor that may cause
adverse effects on safety
and health.”
One major category of work-
place hazards is the catastrophic fail-
ure of machines or structures leading
to injury. Figure 1 dramatically illus-
trates the high energies involved when
a rotor is cracked and fails in opera-
tion. Such failures can be anticipated
if a suitable schedule for monitoring,
maintenance and condition assess-
ment is implemented. For example,
mechanical mobility methods can be
used to assess a structural resonance
which could amplify dynamic forces
in a system including structures,
machines and even the human body.
TC 108 has generated a series of stand-
ards, ISO 7626, which outline accepta-
ble methods for measuring mechanical
mobility and related transfer functions
that, when applied, will provide reli-
able information about the state of the
P. Krieger

system under study for further in-depth

assessment by experts.
ISO Focus July-August 2004 19
Main Focus
Condition monitoring for
reliable hazard prediction
Since prediction of impending
workplace safety hazards relies on the
monitoring changes in normal ope-
rating vibration signatures of critical
systems the quality of the data bases
involved are critical to identifying
precursors to failure. TC 108 is cur-
rently working on a series of standards
which, when taken as a whole, will
form a baseline for making an ISO-
sanctioned vibration measurement.
When complete, these standards will
provide engineers involved in the
workplace with a basic tool for con-
dition monitoring from high-quality
databases where small changes in the
spectral nature of a vibration measure-
ment can serve to predict failure.
Within TC 108, Subcommittee
SC 4, Human exposure to mechanical
vibration and shock, is the standards
body concerned with human exposure
to mechanical vibration and shock. SC
4 is primarily involved with stand-
ardization projects in regard to health,
safety, performance and comfort crite-
ria and with guidelines regarding the
effects of occupational and non-occu-
pational exposure on human popula-
tion. This includes also relevant ter-
minology and characterization of the
biodynamic properties of the human
About the authors
Dr. Bruce Douglas is
founder and Chief
Scientific Officer of
Resonance Technolo-
gies, a technical firm
specializing in the
dynamic design of struc-
tures and vehicles. He currently serving as
Chair of ISO/TC 108 and was Director of
Research at the David Taylor Research
Center, the US Navy’s principal laboratory
responsible for naval vehicles and logistics.
He developed a fundamental theory for
inter-laminar damping in elastic-viscoelas-
tic structures and a key analytical model
for the implementation of active isolation
in multiple input-multiple output structural
systems.
20 ISO Focus July-August 2004
whole-body and the hand-arm system
by means of biodynamic models.
“ The vibration transmitted
by the seat on a seated
person in all kinds of
vehicles affects mainly
the lumbar spine and
the connected nervous
system.”
Human exposure to
whole-body vibration
Human exposure to whole-body
vibration is a widespread occupational
factor that may cause adverse effects
on safety and health. The vibration
transmitted by the seat on a seated
person and/or by the feet on a stand-
ing person in all kinds of vehicles and
mobile machines affects mainly the
lumbar spine and the connected nerv-
ous system. Performance and comfort
criteria may be related e.g. to interfer-
ence with activities as reading, writ-
ing, drinking, etc. and the incidence of
motion sickness.
The standards in the field
of whole-body vibration exposure
(ISO 2631 series) define methods of
quantifying the whole-body vibration
Dr. Eberhard Christ is
the current head of the
department of Physical
Environmental Factors
(noise, vibration, radia-
tion) and Ergonomics of
the BG-Institute for
Occupational Safety and Health – BIA in
Sankt Augustin/Germany. He also serves
as Chair of ISO/TC 108/SC 4, Human
exposure to mechanical vibration and
shock, and chair of the national DIN com-
mittee, Human Vibration Exposure.
At the European level, he is the chair of
the CEN/TC 231, Mechanical vibration
and shock.
exposure by periodic, random and tran-
sient vibration in relation to health and
comfort, the probability of vibration
perception and the incidence of motion
sickness. They do not contain vibration
exposure limits. In the frame of the ISO
2631 series, ISO/TC 108/SC 4 prepares
standards concerning the whole-body
vibration exposure on humans in build-
ings (comfort and annoyance of the
occupants) as well as on passengers
and crews in fixed-guideway transport
systems (comfort in railways). These
standards establish methods for the
evaluation of relative comfort, not
applicable to the evaluation of effects
on human health and safety (Figure 2).
Exposure to hand-
transmitted vibration
The second important area of
standardization on human exposure to
vibration comprises the so-called hand-
arm vibration caused by hand-held and
hand-guided vibration machines/tools,
by vibrating workpieces held in the
hands or by controls of mobile or
fixed machinery. Excessive exposure to
hand-transmitted vibration may cause
muscular/bone structure, neurological
and vascular disorders of hand and
arm.
The standards in the field of
hand-transmitted vibration (ISO 5349
series) define methods of quantifying
the human exposure by periodic, ran-
dom or non-periodic vibration. They
provide also guidance for the evaluation
of hand-transmitted vibration but do not
define limits of safe vibration exposure.
Part 2 of ISO 5349 provides guidelines
for the measurement and evaluation
of hand-transmitted vibration at the
workplace.
In principle, all defined meas-
uring and evaluation methods in the
standards regarding the vibration expo-
sure of humans can form the bases to
set legal requirements by the competent
authorities for occupational safety and
health. Manufacturers and designers
will be able to ensure that their prod-
ucts are in conformity with essential
safety requirements (Figure 3).

Photo © ISO
I
n a tight world economy, there
Radical is no place for unreliability. This
improvements in is true of all fields, including
cranes. To keep cranes shipshape, in a
crane safety constant state of readiness, and prop-
erly maintained is no longer desirable
– it is simply vital. Question : How
do you make them safe and reliable ?
Answer : By introducing quality
By Rolf Lovgren, former Chair,
crane safety management. And to do
ISO/TC 96, Cranes, SC 5, so, one key weapon, and particularly
Use, operation and maintenance effective one – International crane
of cranes standards.
Safe machinery
saves lives
Through my job, that has taken
me to practically every industrialized
country in the world, I have become a
fervent advocate of international crane
standards. Having seen them at work,
I have seen the advantages they can
bring to the crane industry in terms of
safety, of reputation and in costs. And,
what is true for cranes is certainly true
for a good number of similar indus-
tries.
“ In a tight world economy,
there is no place for
unreliability.”
There are nearly 10 million
cranes in operation today worldwide,
on such a scale, it is barely surprising
that economies can be big when crane
management programmes are fully
implemented: potentially, an estimated
USD 3 billion per year can be saved.
But money is not the only consider-
ation. Safety is another – and a truly
vital one.
Lower costs, better
quality, fewer accidents
International crane standards
set up conditions under which every-
one wins. Crane builders can count
on producing better, higher quality
products. Crane operators enjoy safer
working conditions and cranes with
improved ergonomics. Firms can rely
on increased crane productivity with
lower costs for use and maintenance.
And business in general can expect
fewer accidents, increased operational
safety, and increased reliability.
Proper preventive maintenance
routines increase the reliability of equip-
ment performance. Using a mandato-
ry defect history database, combined
with inspections and repairs carried out
by qualified crane specialists, decreased
safety-related faults are found. By spec-
ifying qualification requirements for
operators and specialists to train them,
safety is enormously improved (crane
operator errors lie at the root of 73% of
all crane accidents). International Stan-
dards provide crane maintenance firms
ISO Focus July-August 2004 21
 The story of a safe handler
Main Focus
Let’s look at a shining example of the implementation of crane inspec-
tion and condition monitoring standards for 500 cranes in an automotive

Photo © CranePartner International

plant (General Motors/Saginaw Metal Casting Operation, Saginaw, Michigan
USA).
GM’s Powertrain operations engine-block casting facility in Saginaw
was first established in the 1920s, and has grown since then to having approxi-
mately 140 000 m² under roof. They use 500

Photo © GM
cranes/hoist in their operations, in 24 differ-
ent locations within the plant, made by 22
Control panel in a overhead bridge crane. different manufacturers, with capacities rang-
ing from 0,125 to15 tons. The average crane/
hoist is 20 years old.
Photo © CranePartner International

They set out to increase safety, reduce

costs and be on world-class level as far as
crane safety and maintenance are concerned.
So what did they do ?
GM’s Powertrain operations engine-
block casting facility in Saginaw decided to implement ISO’s Internation-
al Standards on crane inspection and condition monitoring ISO 9927:1994,
Bridge wheels badly worn, rail broken, no Cranes – Inspections – Part 1: General, and ISO 12482: 1995, Cranes – Con-
brakes etc. dition monitoring – Part 1: General, for their crane maintenance.
CranePartner International’s service division in Michigan (CraneCare
Inc.) was selected for the implementation and maintenance for 500 cranes/
hoists in the plant.
Photo © CranePartner International

Operations started in 1997 by tailoring individual checklists for every

crane/hoist, collecting information about operational data etc. and adapting
the CranePartner Crane Maintenance and Condition Monitoring programme
(CranePartner System CPS) for the task.
And the results ? Development between June 1997 and December 2001
was as follows :
Stell structure damages caused by wery rough • Crane defects have declined from average 7,2 / Hoist/Year in 1997 to 0,85/
handling. Hoist/Year in 2001 (see diagram p. 23)
with tools to evaluate how well they • Crane Maintenance Costs have declined from average USD 1 274/ hoist/
are doing in meeting their customer’s year, to USD 580/hoist/year (see diagram p. 23)
requirements. In my experience with • GM/SMCO purchase specifications for cranes are similar to ISO crane
crane operations in paper mills in North standards.
America and Europe, such maintenance
practice has reduced maintenance cost
from 33% to 64% while reducing fail-
ures between 46% and 60% and safe- The only market that The marketplace, obviously, is now
ty incidents between 33% and 97%. counts is the world global: with cranes, the only market
Results of International Standard level that counts is the world market, and
maintenance in steel mills is also impres-
market competition is fierce: by applying self-
sive: maintenance costs reduced by from Throughout the world, there are agreed International Standards, a lot of
28% to 56%, failures reduced by 50% increasing safety and environmental the grind is taken out of maintenance
up to 83% and safety incidents by 63% demands and regulations, and the cus- work as components and procedures
up to 95%. The demanding automotive tomer’s expectations are constantly on are standard.
industry in USA (namely, in General the rise. New technological develop- International Standards lead to
Motors) has seen some radical improve- ments simplify procedures and main- higher quality, which, in turn, means
ments in crane safety and reduced main- tenance if properly channelled through higher safety, greater reliability, and
tenance costs after focusing their crane International Standards. enhanced customer satisfaction, giv-
management on international crane stan- A modern comprehensive ing those that apply them an all-round
dards (see box opposite). Annual crane crane maintenance programme pays image of a professional global service
defects have declined by 86% and main- substantial dividends when it is con- provider. To become – and to remain
tenance costs by 57%. gruent with International Standards. – a successful service provider means
22 ISO Focus July-August 2004
 Safe machinery
saves lives
What ISO crane
standards can offer
ISO/TC 96 works on standard-
ization in the field of cranes, lifting
appliances, and related equipment,
particularly general design procedures,
terminology, classification, load rating,
Photo © Man

terminology, safe use, maintenance,

inspections and condition monitor-
ing, crane selection etc., through nine
subcommittees with delegates repre-
paying special attention to develop- Crane operation and senting national standards groups from
ing and maintaining services which maintenance is difficult 30 countries. These are: subcommittee
follow global requirements: this gives SC 2, Terminology, SC 3, Selection of
to obtain
the assurance that you are on the right wire ropes, SC4, Test methods, SC 5,
track, at present and for the future. There are three basic approach- Use, operation, and maintenance, SC
es to crane maintenance: maintenance 6, Mobile cranes, SC 7, Tower cranes,
Decline in by in-house crews; service contract by SC 8, Jib cranes, SC 9, Bridge and
4000 crane defects the manufacturer, and service contract
500 cranes in automotive plant gantry cranes, SC 10 (previously SC
by a third-party crane maintenance 1), Design procedures.
3500 Defects/Year
• organization. All three approaches Crane safety improvement stan-
Safety related
defects are appropriate if personnel have suf- dards are used to:
3000 Production related ficient knowledge of both cranes and
defects maintenance. • “Design/specify” a safe crane.
•
2500
• Total All the elements necessary for
building a world-class crane manage-
• “Buy” a safe crane
2000
ment programme are included in the • “Maintain” a safe crane.

1500
International Standards, even though • “Use” the crane safely.
the design and execution of such
a programme will still have to be
1000 •
coordinated by the plant maintenance
“ Crane operator errors
1500 • organization or an outside group con- lie at the root of 73 % of
• tracted to handle the responsibility. all crane accidents.”
1000 The comprehensive crane maintenance
1997 1998 1999 2000 2001 programme will include crane inspec-
tion and evaluation by knowledgeable
engineers, preventive maintenance About the author
tasks by operators and maintenance
Decline in Rolf Lovgren
crane costs Material
specialists, predictive maintenance
120 % was Chair of
500 cranes in automotive plant cost technologies, and computerized main- ISO/TC 96
Labor tenance management systems.
Cost/Year cost Cranes, SC 5,
100 % • Comprehensive knowledge Use operation
• • Total of crane operation and maintenance and maintenance
is difficult to obtain. Pockets of of cranes
180 % • excellence exist in crane builder and between 1986
crane user companies and organiza- and 2004. He is
tions throughout the world. But if no a member of
160 % •
country or company has succeeded ANSI/ASME
in gathering all the best knowledge B30, Standards Committee for Cranes
140 % • (USA), US Delegate to ISO/TC 96 and
and practice for designing, building,
MIOSHA advisory board member for
installing, operating and maintaining Crane Safety (Michigan OSHA).
120 % cranes, the efforts of ISO/TC 96 have Mr Lovgren is President and CEO of
been promising in this field. One of the CranePartner International Inc. and has
most valuable committee activities for been in the crane and maintenance
110 % maintenance organizations is the stan- engineering business worldwide for over
1997 1998 1999 2000 2001 dard for condition monitoring. 30 years.

© CPI 2002 ISO Focus July-August 2004 23

 Photo © ISO
Main Focus

Ergonomics :
the road to health,
safety and
efficiency

By Dr. Armin Windel, Head of

Ergonomics Unit, Federal Insti-
tute for Occupational Safety and
Health, Germany, and delegate
to several working groups ISO/
TC 159, Ergonomics

A
retrospective survey of ergo-
nomic standardization in recent
decades shows that some widely
differing objectives have been pursued
in European and international stand-
ardization activities. Work on imple-
menting guidelines on the improve-
ment of safety in the workplace began
with European and national standards
back in the 1960s. With regard to the
ergonomic design of products, this has
meant – and continues to mean today –
that the fundamental principles of ergo-
nomics need to be taken into account in
development, production and use, and
thus in all phases in the life of a prod-
uct. Since the 1970s, European and
international standards have increas-
ingly aimed at consumer protection
while safeguarding free movement of
goods. Consequently, ergonomic prin-
ciples also have to be considered in the
design of work systems. Fundamental
ergonomic knowledge was increas-
ingly “ bundled ” in the 1980s, chiefly
in international standards.
The Vienna Agreement as well
as the need for globalization have
prompted those concerned in the recent
past to look for common ground in
these three approaches which are appar-
ently difficult to reconcile. The route
being followed at present envisages a
standardization procedure according
to the Vienna Agreement being con-
ducted in parallel at the international
and European levels. At present, only
standardization procedures for which
there is a European directive and for
24 ISO Focus July-August 2004
“ Our standards take
account of the aims of
preventive industrial
safety, increase
the performance of
man-system interaction
and improve the
cost-effectiveness of the
complete system.”
which mandating is planned are fol-
lowed under European direction.
In the meantime, there are a
large number of projects in ergonomic
standardization which have been han-
dled in that way and therefore meet
the various requirements. Below, I
describe three areas of ergonomic
standardization that go to show where
the emphasis lies at present.
No clear structure yet
in ergonomics
While a classification according
to basic standards, product group and
product standards is required and has
been largely implemented in the area
of standardization of machine safety,
a similarly clear structure has been
lacking to date in ergonomic stand-
ardization. It is consequently still the
case that ergonomic requirements are
described in many ways and to some
extent in slightly differing terms. Work
is therefore in progress on a guiding and
integrating framework. The basic stand-
ard ISO 6385, Ergonomic principles in
the design of work systems, pursues the
aim not just of stipulating the principles
of ergonomics in relation to the design
of work systems but also of describing a
framework concept in the best sense of a
“ base ” standard, on which other stand-
ards on specific topics can be based.
At the European level, it is nec-
essary to underpin the requirements of
the Machinery Directive on ergonomic
design with (mandatory) standards.
General principles of ergonomics in
relation to the safety of machines are
described in the EN 614, Safety of
machinery – Ergonomic design prin-
ciples. In common with EN 13861,
Safety of machinery – Guidance for the
application of ergonomic standards in
the design of machinery, which can be
understood as a guide to the considera-
tion of ergonomic aspects in product
standards, knowledge of the design and
use of machines and experience gained
from incidents, accidents and injuries
is brought together here. Combination

with international standardization is
also aimed for and is already being put
into practice for this area of European
standardization.
A new framework for
visual display terminal
work
Another prime concern of inter-
national ergonomic standardization is
the revision and restructuring of the
ISO 9241 series of standards on visual
display terminals. Because of the great
significance of work equipment and
the steady development of technology
in the area of visual display terminal
work, the ISO 9241 series of standards
has become very widely known.
When the scope of this series of
standards was expanded by eliminating
the limitation to office work, the group
title of the standard was changed from
“ Ergonomic requirements for office
activities with visual display terminals ”
to “ Ergonomics of man-machine inter-
action ”. The restructuring of ISO 9241,
in particular logical numbering of the
parts of the standard and the integra-
tion of what to date have been separate
standards, also pursues the aim of giving
this increasingly significant subject area
a stronger, guiding framework. Topics
which are of current interest and much
(Continued overleaf)
About the author
Dr. Armin
Windel studied
Psychology at
the Ruhr-Univer-
sity of Bochum,
Germany. From
1991 to 1999 he
was scientific
assistant and
lecturer at the
department of
industrial and organizational psychology.
Since 1999 Dr. Windel has been a member
of the Federal Institute for Occupational
Safety and Health in Germany, where he is
head of the Ergonomics Unit. He is
involved in several working groups of ISO/
TC 159, Ergonomics, and CEN/TC 122.
Safe machinery
saves lives
Designing worker-friendly work
A new International Standard on the design of work systems is expected
to result in improved user health, safety, and performance as well as cost savings
for business.
A work system involves a combination of people and equipment, within
a given space and environment, and the interactions between these components
within a work organization.
A work system, whether directly or indirectly, may contribute to a
plethora of mental and physical health problems and can result in increased
absenteeism, poor timekeeping and staff turnover – all of which affect the pro-
ductivity and efficiency of the organization and have a negative effect on the
bottom line. To avoid these negative effects, it is necessary to fit the work system
to the user.
ISO 6385:2004, Ergonomic principles in the design of work systems,
offers a route to improving the interface between individual users and the com-
ponents of their working situation – such as tasks, equipment, workspace and
environment – right from the beginning of the design process.
For example, concerns over family problems may cause distraction,
predisposing workers
to errors. The right
design of workplaces
can minimize the poten-
tial for human error or,
where concentration is
vital, provide additional
social support.
The new stand-
ard provides a frame-
work for the design of
new or existing work
systems, with a view
to facilitating the work
behaviour and well
being of users, from
office staff to assembly-
line workers. Its guidance may also apply to the design of products for domestic
and leisure activities.
ISO 6385:2004, which replaces ISO 6385:1981, has been updated to
include a description of the design process, definitions of ergonomics and ergo-
nomic design principles and gives an overview of the components involved in
the design of a work system.
“ ISO 6385 is relevant for all sectors, not only heavy industry, but also
the growing service industries and the health sector,” says Wietske Eveleens,
Convenor of the working group that developed the new standard. “ ISO 6385
helps professionals in the creation of durable solutions when facing the chal-
lenge of human-centred technical innovation in a quickly changing world.”
The new standard is aimed to be used by managers, workers (or their
representatives) and professions such as ergonomists, human resources, project
managers, and designers who are involved in the design or redesign of work
systems.
ISO 6385:2004 is the work of ISO technical committee ISO/TC 159,
Ergonomics, subcommittee SC 1, Ergonomic guiding principles.
ISO Focus July-August 2004 25
Main Focus
in demand such as usability, accessibil-
ity and multimedia and mobile devices
are obviously also taken into account.
In addition, it supports practical imple-
mentation of the European VDU (Visual
Display Unit) Directive.
Still underestimated :
mental workload and stress
Processes which are described
by terms such as “ structural change ”,
“ flexibilization of work ” or “ dynam-
ics of the world of work ” are char-
acteristic of massive restructuring
activities around the world. For
employees, they are associated with
radical changes in their working con-
ditions, which may lead to changes
in areas of activity, new challenges,
but also changed and, in some cases,
higher workloads.
On this basis there is agreement
both internationally and in Europe
that avoiding or reducing work-related
incorrect loads has become a focal
point for action in order to promote the
Photo © ISO
26 ISO Focus July-August 2004
safety and health of employees but also
performance attainment in enterprises.
Not least because of the consideration
of mental workload in European leg-
islation, the need for many enterprises
and employees for detailed consultation
on the topic of “ mental workloads ” has
steadily increased in recent years.
The honour of having cre-
ated a suitable basis of understanding
on this topic goes to the ISO 10075
series, Ergonomic principles related to
mental workload. Problems of under-
standing still exist if mental work-
loads are misunderstood as individual
shortcomings on the part of the person
concerned and are not recognized as
shortcomings in working conditions
in the enterprise. Alongside precise
definitions of the terms “ mental work-
load ”, “ mental stress ” and their poten-
tial negative consequences (Part 1), the
standard series does not just offer
assistance in measuring and assessing
incorrect mental workloads (Part 3), it
also offers tips in the second part on
optimizing working conditions.
We promote industrial
safety and
cost-effectiveness
As this brief survey of current
focal points for action in ergonomic
standardization shows, the activities
in ISO/TC 159 are aimed at taking
better and adequate account in future
of human characteristics, capabilities
and skills in the design of products
and work systems. Concept-related
work and the restructuring of exist-
ing standards also raises the suitabil-
ity for use of the product known as
“ standard ” for the user. To summa-
rize, the standardization activities in
ISO/TC 159 take account of the aims
of preventive occupational safety and
health, increase the performance of
man-system interaction and improve
the cost-effectiveness of the complete
work system.

Burning a trail
ahead in
protective clothing
By Mick Smith, Chair ISO/TC
94/SC 14, Firefighters personal
protective equipment
F
irefighting personnel are putting
their lives on the line ; any work
done by TC 94/SC 14 to ensure
that what they wear and the equipment
they use is better suited to the task
will benefit firefighter safety around
the world. That is our goal, and the
recent meeting of the subcommittee 14
in Adelaide, Australia, served to show
how internationally our group’s work
is burning a trail ahead and progress-
ing knowledge and safety methods to
this end.
Previous annual meetings of TC
94/SC 14 were held in London, Berlin
and Winnipeg. The 2001 meeting in
London occurred after 9/11: it responded
to the obvious need of firefighters for
appropriate PPE (personal protective
equipment). This need has never been
so evident as today, after the bombings
in Oklahoma City (April 1995), 9-11,
the Bali nightclub, Madrid train, and
other events where firefighters have to
cope with very dangerous situations.
The working groups were crafted
according to the risk that firefighters
face. Each working group is working
towards developing a single standard
for PPE that, when used, will protect
the firefighter against the risk.
Subcommittee SC 14 is made
up of five working groups :
WG 1, General requirements
WG 2, Firefighting – structural
WG 3, Wildland firefighting
WG 4, Hazardous materials incidents
WG 5, Non-fire rescue incidents
“ The standards writers
needed to see the
personal protective
equipment in action to
fully understand the end
use by the people wearing
the ensemble”.
Safe machinery
saves lives
What is involved in
rescue ?
Standards Australia along with
the South Australian Metropolitan
Fire Service (SAMFS) hosted the
fourth conference meeting of SC 14
in Adelaide, at the SAMFS Training
Centre, between May 31 and June 4,
2004.
At our meeting, a day was set
aside as a workshop wholly devoted to
work involved in WG 5, Rescue per-
sonal protective equipment or Non-fire
personal protective equipment. This
covers road accident rescue, high angle
rescue, urban search and rescue, trench
rescue, confined space rescue, swift
and still water rescue and industrial
rescue. These have been categorized
by WG 5 into four distinct groups;
rope rescue, rescue from water, rescue
from vehicles and plant and special
rescue.
The event was intended to
facilitate discussion and to demon-
strate techniques under each of the
four categories of rescue identified
by WG 5. Its purpose was to provide
a greater appreciation of what is
involved in rescue, so that the suite
of standards to be written for rescue
ISO Focus July-August 2004 27
Main Focus
The ISO/TC 94/SC 14, Firefighters personal
protective equipment, conference was held
in May-June 2004, in Adelaide, Australia, and
attended by 44 committee members and 20
observers during the week.
Convenors of the Working Groups met for a
pre-conference. A complete day was set aside
for a workshop with practical demonstrations
for WG 5, Rescue (or or Non-fire) personal
protective equipment.
personal protective equipment is based
on assessments of hazard and risk. The
aim was also to lay the foundations for
a forum of discussion amongst rescu-
ers on procedures, techniques, etc. to
support the hazard and risk analysis on
which the ISO standards will be based.
This was run as an observation exer-
cise for standard writers, test houses
and manufacturers.
WG 5 is responsible for rescue,
and the workshop gave this group
greater insight into personal protec-
tive equipment (PPE) currently worn
by Emergency Services in South
Australia. They looked at :
• Helmets
• Boots
• Gloves
• Clothing
• Eye protection
• Hearing protection
• Communications, and
• Other Safety Features
28 ISO Focus July-August 2004
Ensuring the same
protection level is
afforded to all
The practical demonstrations
given by SAMFS training officers,
and South Australia’s ambulance
services, country fire services, state
emergency services, police special
tactics and response group and avia-
tion rescue and firefighting division
were the key to the success of the
day. Alec Feldman from GD Group
of Companies, Ireland, convener of
WG 5, said ; “ In all my involvement
around the world in formulating
standards, I myself and many of the
others here have never seen anything
like this done before. The standards
writers needed to see the personal
protective equipment in action to fully
understand the end use by the people
wearing the ensemble ”.
“ The acceptance of
International Standards
as an alternative to local
standards is an important
step forward.”
Firefighters, test houses and
manufacturers from around the world
are committed to standards development
and, in this case, firefighter personal
protective equipment. The development
of International Standards and their
acceptance as an alternative to
local standards is an important step
forward. TC 94/SC14 is fostering the
compilation of the work of technical
experts and end-users from a diverse
range of countries and climates that
will ultimately apply the standard to
their own needs – but with the same
protection level afforded to all.
A lot of the protection for
firefighters comes in the form of
technological advances in materials
that the PPE is made from, but we
cannot rely on this alone. Firefighter
PPE must be aligned to training and
safe work practices in order for it to
fully protect the wearer.
The varied disciplines
of rescue mean different
clothing needs
One of the problems ISO/TC 94/
SC 14 has is that in this diverse world
and the variety of areas firefighters
now work in, firefighting itself only
amounts to approximately 10 % of their
total work output. It is also accepted
that the protective performance levels
of PPE set down in current standards
About the author
Mick Smith,
Chair of ISO/TC
94/SC 14, Fire-
fighters personal
protective equip-
ment (PPE),
has been Deputy
Chief Officer of
the South Aus-
tralian Metropol-
itan Fire Service
(SAMFS) since September 2002. Mick
Smith joined the Fire Service in January
1978, aged 21. In January 1986, he was
promoted to Senior Firefighter, in Decem-
ber 1987 to Station Officer, in July 1998 to
District Officer, and in July 2000 to
Commander. Mick was also the Leader of
the Australian Delegation to ISO/TC 94/
SC 15, Respiratory protection. He has also
been involved in a number of Australian
and Australasian committees on the
subjects.
Test methods for protective clothing
to reduce injury and death

Safe machinery
saves lives
Health care workers that treat and care for the sick and injured, as
well as categories such as rescue personnel, paramedics, veterinarians and
laboratory technicians, may be at risk from biological liquids transmitting
disease. ISO is helping to reduce the risk by two International Standards for
evaluating the effectiveness of their protective clothing.
“ The risk of contamination by viruses such as AIDS, HIV, hepatitis
and others from blood or other body fluids is a constant source of concern
for health care staff, and the two standards provide a tool to assess the bar-
rier capacity of the materials used for these protective garments,” says Fred
Foubert, Deputy Convenor of the ISO group of experts that developed the
standards.
The new standards describe laboratory test methods for measuring the
penetration resistance of clothing materials to blood, body fluids and other
potentially infectious materials. They will enable manufacturers to develop are aimed at protection against
protective clothing that will reduce the potential of direct skin contact to a exposure to “ worst possible ” fire
variety of blood-borne viruses by medical personnel. scenarios, i.e. flashover conditions or
ISO 16603:2004, Clothing for protection against contact with blood ensembles for wildland conditions.
and body fluids – Determination of the resistance of protective clothing The rest of the time is occupied by
materials to penetration by blood and body fluids –Test method using syn- the various other disciplines of rescue.
thetic blood, will be used to determine the resistance of materials to synthetic From this, fire services have used
blood when exposed to physical stresses and pressures exerted on protective combinations of firefighting clothing
clothing in use. levels to accomplish rescue. This is
far from an ideal situation, and indeed
ISO 16604:2004, Clothing for protection against contact with blood should be considered as inappropriate
and body fluids –Determination of resistance of protective clothing materi- PPE. More seriously, this can mean
als to penetration by blood-borne pathogens –Test method using Phi-X174 that for 90 % or more of the work of
bacteriophage, will help detect micro-holes in materials using a microorgan- firefighters, they are wearing PPE that
ism that is similar to the hepatitis C virus in size and shape but also serves could add to the risk of heat stress.
as a substitute for the hepatitis B virus This makes
and HIV (human immunodeficiency the work of WG 5
viruses). under Alec Feldman
“ There are a large number of one of the biggest
potential users of these standards, or of challenges of TC 94.
people who could benefit from them. The workshop at the
This not only concerns health care Adelaide conference
professionals in the strict sense such assisted in the educa-
as doctors and nurses, but also rescue tion of standards writ-
workers, paramedics, veterinarians, ers to the facts of the
people who come into contact with situation. Fire servic-
dead animals, laboratory technicians es tend to be steeped
etc.”, further noted Mr. Foubert. in history when it
comes to changing
“ We hope these test methods work practices : and,
will provide a good basis for the evalua- after the completion
tion and further development of materi- of this ISO standard,
als used in protective apparel for a wide ISO/CD 11613, it will
group of people, especially people our now be a huge effort
lives could depend on.” to educate fire servic-
ISO 16603:2004 and ISO es around the world to
16604:2004 are the work of ISO tech- duly implement it.
nical committee ISO/TC 94, Personal
safety – Protective clothing and equip-
ment, subcommittee SC 13, Protective
clothing.

ISO Focus July-August 2004 29

Photo © ISO
Main Focus
Reducing the risk
of hearing damage
By Dr. Klaus Brinkmann, Chair
ISO/TC 43, Acoustics
I
n daily life, acoustics is usually
associated with positive sounds
like music and speech communica-
tion. Unfortunately, however, acoustics
also has a grave negative side which
becomes obvious when sound turns
into noise. The main objective of ISO/
TC 43, Acoustics, and its subcommittee
1, Noise, is to deal with this negative
side, and to contribute towards a reduc-
tion of unwanted effects of sound.
It is said that some 20 % of the
total population in Europe is exposed
to noise levels in their living environ-
ment that exceed the acceptable limits
set by the scientific and medical com-
munity, leading to manifold physical
and psychological irritations for the
people concerned. Such effects are,
however, difficult to quantify. More
solid data exist for noise-induced
hearing damages at workplaces, how-
ever. In Germany, for instance, hearing
impairment has been at the top of all
occupational impairments for many
30 ISO Focus July-August 2004
years, and the resulting annual social
and economic costs are of the order of
magnitude of 120 million USD. Other
industrialized countries are faced with
similar problems.
Noise measurement
results from different
sources
It is beyond the brief of ISO/TC
43 to enforce non-dangerous working
conditions directly – this is an issue
that has to be left to the economy and
to legislation – but TC 43 does provide
a significant contribution towards safer
workplaces by delivering a variety of
proper tools to achieve this goal. Let
us look at these.
“ We have developed
guidance on the design of
low-noise machinery and
equipment and the design
of low-noise workplaces.”
Measurement standards: The
standardization of well-established
and reproducible methods for noise
measurements is the main field of
activity of TC 43/SC 1. Such stand-
ards are closely related to noise limits
prescribed by national or regional leg-
islators, and form the basis for deci-
sions on whether criteria are met or
on whether noise reduction measures
have to be initiated by manufacturers
or customers for machinery.
Considering the diversity of
machinery in use (from small hand-
held devices to big industrial plants),
of given acoustic environments for
measurements (from in situ to labora-
tory conditions), and the intended use of
data (from characterization and label-
ling of machinery to evaluation of noise
exposure at workplaces), it is obvious
that no one single procedure is going to
be suitable in all situations. Instead, TC
43/SC 1 offers families of framework
standards for different applications (e.g.
the ISO 3740 family for sound power
measurements, the ISO 9614 series for
sound intensity and the ISO 11200 fam-
ily for sound pressure at work stations).
Guidance is given on the selection of
the most appropriate standard in a given
situation. To meet the needs of custom-
ers who sometimes complain about the
complexity of noise measurements and
their costs, SC 1 offers, wherever pos-
sible, a selection of procedures rang-
ing from precision methods providing
most accurate results to simple survey
methods.
In order to get reliable results,
machinery specific data, like operat-

ing and mounting conditions, have to
be specified in addition to the basic
acoustical requirements in so-called
“Noise Test Codes”. SC 1 provides
guidance on how to write a suitable
code, but leaves the work itself in
most cases to product committees
where more relevant knowledge on the
machinery in question is likely to be
available. However, TC 43 establishes
close cooperation with these commit-
tees in maintaining its overall responsi-
bility in all questions related to noise.
“ Industrial customers,
noise consultants, safety
inspectors and testing
laboratories appreciate
the assistance of ISO
standards.”
A big challenge at present to the
continuous process of updating exist-
ing standards and their adaptation to
new technologies is the proper treat-
ment of measurement uncertainty.
Sufficient knowledge to apply in full
the ISO Guide to the Expression of
Uncertainty in Measurement (GUM) is
not always available yet, but it stands
to reason in ISO/TC 43 that measure-
ment results from different sources
cannot be meaningfully compared
without reliable uncertainty data, and
reasonable decisions on the fulfilment
of any criteria cannot be taken without
knowledge of the uncertainty in meas-
urement either.
Selecting hearing
protectors is not easy
Noise reduction: No universally
applicable methods exist to reduce
noise at its source or to shield work-
ing places against noise by enclosures,
screens or insulating cabins. For this
reason, the means of noise reduction
are not really a field of standardization,
and any harmonized specifications
bear the inherent risk of hindering
technical development. Nevertheless,
customers often ask for guidance and
– mainly to fulfil demands arising from
the European Machinery Directive
“ We offer help on how
to measure the hearing
function and how to
calibrate audiometric
equipment to achieve
comparable results.”
– TC 43/SC1 has therefore developed
several standards on the design of
low-noise machinery and equipment
(ISO 11688 series), the design of low-
noise workplaces (ISO 11690 series)
as well as on performance measure-
ments on sound insulating enclosures
(ISO 11546 series), removable screens
(ISO 11821) and cabins (ISO 11957).
Industrial customers, noise consult-
ants, safety inspectors and testing
laboratories appreciate this assistance.
Personal sound protecting devic-
es: If none of the general noise reduc-
tion means described above manage
to exclude the risk of impairing the
hearing of the workers, the ultimate
solution is the use of personal hearing
protectors. The market offers a variety
of products. However, the selection of
the right model in a given noise situa-
tion is not an easy task. SC 1 has devel-
About the author
Dr. Klaus
Brinkmann has
been chair of
ISO/TC 43,
Acoustics and
TC 43/SC 1,
Noise since
1987. He
received his uni-
versity degree in
physics in 1963
and then worked for 40 years at Germany’s
National Metrology Institute – initially in a
laboratory for acoustics and finally as head
of a division with diverse scientific and
technical cross-sectional tasks. Besides his
work in ISO/TC 43, he has chaired various
technical committees in international and
regional organizations such as the Interna-
tional Organization of Legal Metrology,
CEN (European Committee for Standardi-
zation), and the European Cooperation for
Accreditation (EA).
Safe machinery
saves lives
oped a number of measurement stand-
ards suitable for providing comparable
hearing protector performance data
(ISO 4869 series). Moreover, guidance
is given on how to adapt frequency-
dependent attenuation data of hearing
protectors in a simple way to the noise
spectrum in a given situation.
Monitoring of the hearing
performance
Hearing conservation pro-
grammes: Any relationship established
between noise exposure and resulting
hearing damage are only statistically
valid. Individuals may be affected in
quite different ways. There is no doubt,
however, that the damaging effects of
noise build up over a lifetime, and
its impairment to hearing, once it has
occurred, is hard to repair. Because
of this, a permanent monitoring of the
hearing performance of workers con-
cerned is usually indispensable. Such
programmes provide a basis, e.g. for
decisions on additional noise reduc-
tion measures, for the selection of most
endangered persons at an early stage,
for diagnosis and therapy of hearing
impairment and, in the worst cases,
for proper financial compensation of
a definitive hearing loss. ISO/TC 43,
again, offers help for such programmes
by providing standards on how to
measure the hearing function (ISO
6189 and ISO 8253 series) and how
to calibrate audiometric equipment
(ISO 389 series) in order to achieve
comparable results. The latter is done
in close cooperation with IEC/TC 29
that is responsible for the performance
specification of such equipment, while
TC 43 specifies an audiometric zero
representing the average threshold of
hearing of young otologically normal
persons around the world.
In sum: though ISO/TC 43 can-
not directly reduce the risk of hearing
damage at workplaces and the result of
its work is not really quantifiable, its
contributions to achieve safer work-
ing conditions are manifold and are
well acknowledged by all parties
concerned.
ISO Focus July-August 2004 31
Main Focus
The value
of statistical
techniques
By Lally Marwah, Convenor
of the working group for
ISO/TR 10017:2003, Guidance
on statistical techniques for
ISO 9001:2000
T
he quality of product or serv-
ice delivered to a customer is
among the key objectives of
every business. To achieve this objec-
tive in a consistent and effective man-
ner requires an organization to develop
a comprehensive quality management
system (QMS) which ensures that
customer requirements are captured,
translated into goods or services, and
delivered to the customer’s satisfac-
tion.
Data – and the analysis of data
– is central to the management of qual-
ity, as it is to every other aspect of an
enterprise. This is therefore reflected
in all QMS models, the most well
known worldwide being the ISO 9001:
2000 Quality Management System.
Figure 1 – ISO 9001:2000 QMS model
32 ISO Focus July-August 2004
Photo © ISO
The primary elements of the
ISO 9001:2000 QMS model are
depicted in Figure 1. The detailed
requirements that underlie the primary
elements are provided in the ISO 9001:
2000 standard. In the model above, it is
clear that the role of data – specifically
measurement and analysis – is central
to the continual improvement cycle of
the business that holds customer satis-
faction as its ultimate objective.
The role of data is similarly
recognized in other well-known QMS
models, notably those associated with
quality awards established in various
parts of the world to promote organi-
zational improvement.
Most well-known in the USA.
is the Malcolm Baldrige Award, which
recognizes business excellence. While
the criteria for this award have evolved
over the years, the effective use of data
has remained a specific and central
requirement.
More familiar to organizations in
Europe is the EFQM Excellence Model
that underlies the European Quality
Award. This model identifies its criteria
under the broad headings of “ enablers ”
and “ results ”, and these are guided by
“ fundamental concepts of excellence ”.
In this case, the role of data is embed-
ded in the guidance provided for award
criteria (“ management by …facts ”).
Another internationally respect-
ed quality award is The Deming Appli-
cation Prize in Japan, which recogniz-
es “ distinctive performance improve-
ment through the application of TQM
(Total Quality Management) ”. This
award not only endorses a manage-
ment system “ based on facts ”, but
strongly reinforces the role of data
through explicit reference to the use of
statistical techniques to maintain and
improve business performance.
Variability – and the role
of statistical techniques
Some degree of variability is
present in all processes – even under
conditions of apparent stability – and
can be observed at various stages of
the total life cycle of products. Such
variability can be said to ultimately
account for problems or issues that
constitute “ poor quality ”.
The value of statistical tech-
niques stems from their potential
ability – given relevant data associated
with a process or product – to yield
insight into the nature, extent and pos-
sible causes of variability. This insight
can subsequently assist in controlling
or reducing variability, and thereby
improve quality.
The value of even elementary
statistical analysis can be illustrated
by a simple example: the maximum
level of noise emitted by a device is
set at 45 decibels. To determine if a
large batch of these devices meets this
requirement, a sample of 36 units is
randomly drawn from the batch, and
their noise-levels are measured and
listed in Figure 2a.
It is clear that none of the units
in the sample exceeds the upper limit
of 45 decibels ; but it is not clear what
proportion of the total batch might
exceed the upper limit.

A graphical plot (Figure 2b)
of the same data shows a picture of
a “distribution” that is more revealing
– it suggests that a small percentage of
the batch may exceed the upper limit.
If certain assumptions can be
made about the data, statistical analysis
allows us to estimate that about 0,22%
of units in the batch will likely exceed
the upper limit, even though none in
the sample exceeded that limit.
12
10
Figure 2a – Noise-level (in decibels)
of sample units
Statistical techniques can help
describe, analyze and model variabil-
ity, even with limited data. They can
thereby help improve the quality of
products and processes over the total
life-cycle – from design and develop-
ment, to production and service. Some
commonly encountered applications of
statistical techniques include :
• Assessing or assuring the quality of
incoming material ;
• Control of processes in manufac-
turing and service sectors ;
• Optimizing complex processes to
achieve desired outcomes ;
• Assessing or predicting reliability
of products ;
• Characterizing delivery or response
times in service industry.
ssssss
Such applications play a vital
role in virtually every sector of indus-
try and commerce. While the focus
here is on assessing and improving
quality, it is worth noting that statisti-
cal techniques are also potentially use-
ful in other contexts – for example in
environmental management – to help
establish, achieve and verify perform-
ance targets and goals.
Six-Sigma
In many organizations the use
of statistical techniques is left to the
individual initiative of employees and
managers. In recent years, we have
seen the emergence of a formal ini-
tiative – broadly termed “ Six-Sigma”
– to enable a more focused deployment
of statistical techniques.
Frequency
8 in non-technical language, it identi-
6 fies well-known statistical techniques
4 Upper limit
2 provides a clear and concise descrip-
0 reader to assess its applicability and
34 36 38 40
Noise level (Db)
Figure 2b – Plot of noise level data
Six-Sigma originated as a sta-
tistical concept that calls for a high
level of process capability, so that the
resulting output has a very low level
of defects (in the “parts per million”
range).
Six-Sigma has since evolved
into a broad initiative for driving busi-
ness improvement. It is characterized
by a high level of executive commit-
ment and support for selected projects,
which in turn are aligned to business
priorities. It also typically involves a
significant level of training in the use
of selected techniques – statistical
and otherwise – to ensure successful
results.
In some corporations Six-Sigma
has served not only to achieve high lev-
els of performance, but has also been a
vehicle for developing skills and capa-
bilities in the organization itself.
Safe machinery
saves lives
Guidance on statistical
techniques –
ISO/TR 10017:2003
The effective use of statistical
techniques is greatly influenced by
how well their potential applicability
and benefits are understood by man-
agement.
This need is well served by the
recently published ISO TR 10017:
2003 – Guidance on statistical tech-
niques for ISO 9001:2000 . Written
and their potential applications in a
quality management system. It further
tion of each technique to enable the
42 44 46
benefit, and thereby guide the selection
of techniques appropriate to the needs
of the business.
Thus while ISO/TR 10017:
2003 is specifically aligned to the
requirements of the ISO 9001:2000
standard, it can also provide guidance
on the potential role of statistical tech-
niques in the broad context of business
improvement.
About the author
Lally Marwah
is with Global
Quality manage-
ment at Nortel
Networks, head-
quartered in
Canada. He has
led Nortel Net-
works to ISO
9001:2000, and
primed statistical
methods for business improvement at IBM.
Recently, he led the development of ISO/
TR 10017:2003 – Guidance on statistical
techniques for ISO 9001:2000.
Contact : lmarwah@nortelnetworks.com
Phone : Canada 905-863-3254
ISO Focus July-August 2004 33
Developments and Initiatives
Automobile safety
a dummy
that can
take it all
By the WorldSID Task Group 1)
I
n the automotive safety testing field,
the ISO World Side Impact Dummy
(WorldSID) Task Group has com-
pleted the design and development of
the WorldSID. Developed under direc-
tion of ISO/TC 22, Road vehicles, sub-
committee SC 12, Passive safety crash
protection systems, working group WG
5, Anthropomorphic test devices, begin-
ning in 1997, and funded by a world-
wide consortium at a cost of about 14
million USD, the dummy production
design was completed on schedule in
March 2004. The WorldSID made its
official debut at a United Nations World
Forum for Harmonization of Vehicle
Regulations (Working Party WP.29)
reception on 22 June in Geneva.
The WorldSID heralds a sig-
nificant improvement in the ability of
crash dummies to duplicate human
motions and responses in side impact
tests, which should lead to improved
vehicle designs and occupant protec-
tion. In addition, WorldSID, which was
developed by hundreds of engineers
and scientists from over 45 organiza-
34 ISO Focus July-August 2004
tions in Europe, Asia-Pacific and the
Americas, represents a major break-
through in worldwide harmonization
of crash test dummies.
“ WorldSID was developed
by hundreds of engineers
and scientists from
over 45 organizations in
Europe, Asia-Pacific and
the Americas.”
Effective vehicle occupant
protection design is very dependent
upon the ability of vehicle engineers
to use crash dummies to predict pos-
sible human injuries. The WorldSID’s
biofidelity, a measure of how well
the dummy simulates the forces and
motions of a human, is the best of any
side impact crash dummy to date and
far exceeds the performances of the
others. ISO/TR 9790, Lateral impact
response requirements to assess the
biofidelity of the dummy, specifies
procedures for evaluating side impact
dummy biofidelity performance using
a series of 33 laboratory tests. Based
on using the ISO/TR 9790 rating scale,
the WorldSID rating is 7,6 (“ Good ” on
a 10 point rating scale). In compari-
son, other currently used side impact
dummies, US-SID, EuroSID-2RE,
EuroSID-1, and EuroSID-2, have rat-
ings of 2,3, 4,2, 4,4, and 4,7 respec-
tively. The ability of vehicle safety
engineers to utilize the enhanced bio-
fidelity of the WorldSID should lead
to safer vehicle designs, enhanced side
impact protection, and reduce human
injuries in side impacts.
Making WorldSID
available to the
worldwide vehicle
research community
In addition, as a major ben-
efit of harmonization, introduction
of a single universal dummy into
regulations and consumer testing in all
regions would enable manufacturers
to focus and coordinate resources to
improve worldwide occupant safety,
rather than engineering different safety
designs for different dummies.
As an international group, the
WorldSID Task Group operated under
the leadership of a Tri-Chair, consisting
of one individual from the Americas,
Asia Pacific, and European regions of
the world. Each of the Tri-Chairs served
as chair of their respective regional
Advisory Group and shared the chair-
manship of the Task Group, which is
made up of worldwide representatives
of research facilities, manufacturers,
government agencies, and dummy
equipment manufacturers. One of the
goals of this worldwide group was to
achieve harmonization via the use of the
same dummy in all worldwide markets.
Humans are physically similar world-
wide, so it is logical to have a single
crash dummy to test vehicle safety.
There are presently at least three differ-
1) Risa Scherer, FORD Motor Company,
Chair of the Americas Advisory Group, Akihiko
Akiyama, Honda, Chair of the Asia Pacific
Advisory Group, Edmund Hautmann, BMW
Group, Chair of the European Advisory Group,
with Ken Wiley, DYNAMIC RESEARCH INC.,
WorldSID Phase II Project Manager.
ent adult male sized side impact dummy
designs in use and at least four more
have been developed. One, used by the
US Department of Transportation, has
served as the crash dummy to be used
in the existing US side impact crash
regulation (FMVSS 214). Others were
developed in Europe and are being used
or are being considered for use in crash
tests under European Regulations. The
WorldSID was developed to allow a sin-
gle test device to be used for side impact
testing in any regulation around the
world. Such a worldwide-harmonized
dummy could not have been developed
without the international cooperation
exhibited within the Task Group.
To ensure that the WorldSID
is available to the worldwide vehi-
cle research community, the design
details have been documented in ISO/
WD 15830, Design and performance
specifications for a 50 th percentile male
side impact dummy (WorldSID) – Part
1 : Definitions, symbol and rationale,
Part 2 : Mechanical subsystems, Part
3 : Electronical subsystems and Part
4 : User´s manual, which was recent-
ly approved by ISO/TC 22/SC 12/
WG 5, and is currently being reviewed
and balloted at the Committee Draft
level by ISO/TC 22/SC 12. This doc-
umentation, which consists of nearly
500 pages plus 400 fabrication draw-
ings and CAD files, includes all of the
design details, material specifications,
and performance standards required for
the fabrication of the WorldSID.
Using new materials
to create human-like
performances
The excellent biofidelity of the
WorldSID design is due in part to the
use of new technologies and materi-
als, some of which were not available
for use in older dummy designs. The
WorldSID ribs achieve human-like
deflection performance through the use
of a super-elastic nickel-titanium alloy.
The WorldSID anthropometry is based
on an extensive, diverse 50 th percentile
male driver data set, which resulted in
a more human-like seating position.
In addition the WorldSID can utilize
an optional in-dummy data acquisition
system capable of recording up to 224
data channels, which can lead to a bet-
ter understanding of the loads applied to
car occupants during side impacts.
“ The excellent biofidelity
of the WorldSID design is
due to the use of
new technologies and
materials.”
The technical performance of the
WorldSID design has been thorough-
ly tested and verified by extensive test-
ing under a variety of conditions. The
original prototype dummy underwent
nearly two years of biofidelity, vehi-
cle, and component testing. Based on
the prototype test results, a pre-produc-
tion design was developed which result-
ed in the modification of nearly every
part of the dummy in order to improve
biofidelity, durability, usability, or oth-
er aspects of the dummy. Beginning in
early 2003, 11 pre-production dummies
were fabricated and delivered to each of
the three world regions. The subsequent
worldwide testing of the pre-production
dummies resulted in a few final modi-
fications, which were incorporated into
the final production design. The pro-
duction design is complete and the pro-
duction dummy is currently available
for purchase and use.
In total, testing has included
more than 1 000 whole dummy biofi-
delity, vehicle, and component tests.
This testing was conducted in 16 dif-
ferent test labs and agencies in at least
10 different countries, including testing
by governmental agencies in Canada,
Japan, Australia, the USA, and various
organizations as part of a framework
research programme of the European
Commission.
The future use of WorldSID
in worldwide regulation is now being
reviewed. During its November 2003
meeting, United Nations Working Party
WP.29 agreed that development of the
WorldSID should be encouraged, and
further agreed that EU member states
will make proposals to incorporate the
WorldSID in ECE Regulation 95 once
the WorldSID is shown to be ready for
use, in the expectation that this could
be done before the end of the 36-month
transitional period specified for ES-
2 in the proposed amendment. This
action ensures that the door remains
open for the WorldSID to be consid-
ered for adoption as a replacement in
UN-ECE Regulations for EuroSID-1,
which is scheduled to be phased out
in 2007 in keeping with earlier GRSP
(Global Road Safety Partnership) deci-
sions. Another and separate discussion
involves continued reporting to WP.29/
GSRP, as related to future potential use
of WorldSID in any potential future
Global Technical Regulation for side
impact protection.
The team behind WorldSID with their
“ offspring ” : (from left to right) Jerry Wang,
Member of Design Team, Senior Projects
Manager, First Technology Safety Systems,
USA ; Ken Wiley, Principal Engineer,
Programme Manager, Dynamic Research Inc.,
USA ; Suzanne Tylko, Vehicle Safety Engineer,
Transport, Canada, Secretary of Americas
region, Canada ; John Zellner, Technical
Director, Programme Manager Dynamic
Research Inc., USA ; Risa Scherer, Chair of the
Americas Advisory Group, Anthropomorphic
Test Device Technical Specialist, Ford Motor
Co., USA ; Edmund Hartmann, Chair of the
WorldSID European Advisory Group, Vehicle
Development Passive Safety Testing, BMW
Group, Germany ; Akihiko Akiyama, Assistant
chief Engineer, Honda R and D, Japan ; Klaus
Bortenschlager, Managing Director, PDB,
Germany ; Craig Morgan, Vice-Chair, Denton
Inc., USA, Member of Design Team.
ISO Focus July-August 2004 35
Developments and Initiatives
Best practice for
information
security
By Ted Humphreys, convenor
of ISO/IEC JTC 1/SC 27, IT
Security techniques /WG 1,
Requirements, security services
and guidelines
I
SO/IEC 17799, Information tech-
nology – Code of practice for
information security management,
is the best practice standard for infor-
mation security management. It pro-
vides a broad framework for address-
ing the day-to-day operational issues a
business needs to deal with to protect
its information from a wide range of
threats and risks. This best practice
offers organizations the basis for
ensuring business continuity, minimiz-
ing business damage and maximizing
business investments and opportunities
by deploying information security best
practice.
36 ISO Focus July-August 2004
Insights from
organizations applying
the standard
NTT Japan, through the voice of
Mr. Hisao Iizuka, Executive Vice-Presi-
dent and CSO NTT Communications
Corporation, and Mr. Tomokazu Hama-
guchi, President and CEO, NTT Data
Corporation, made the following state-
ment about the role and importance that
ISO/IEC 17799 has had in its business.
“ ISO/IEC 17799,” they say,
“ is rapidly being diffused throughout
Japan. It is well implemented especial-
ly in the telecommunication industry,
which requires a high level of informa-
tion security. After the privatization of
Nippon Telegraph and Telephone Public
Corporation in 1985, Nippon Telegraph
and Telephone Corporation (NTT) has
been through business segmentation by
the type of business. Ever since, all the
NTT groups are nationally and inter-
nationally recognized as leading com-
panies in telecommunication industry
with their diverse services. Through
the privatization and segmentation pro-
cesses, NTT groups needed to develop
new governance systems of their own
in order to secure a fair and effective
competition. As the rapid dissemination
of Internet gained not only the conve-
nience in communication but also the
potential risks of illegal accesses to the
critical information, the significance of
information security is reaffirmed. In
order for the NTT groups to prove to the
society that they are credible in terms
of information security, they chose to
implement information security man-
agement system with the concept of
ISO/IEC 17799.”
The statement continues : “ Below
are some of the cases that have imple-
mented this system : NTT Communica-
tions – provider for long distance and
international telephone services, Internet
services, and solution services (man-
agement consulting service and system
integration service) – has been certified,
with ISMS (Information Security Man-
agement Systems) at the solution service
department with 4 000 employees. This
case is one of the largest cases in the
world. The other departments are being
certified subsequently.
“ NTT Docomo Groups,
mobile telecommunication service
providers, are individually certified
with ISMS in each regional office,
including NTT Docomo Kansai.
“ The primary service of NTT
Data is System Integration (SI). Its
R&D department for ISMS was firstly
certified and continues to expand the
certification as SIer to sector depart-
ments including the Public Sector Ser-
vice Division.
“ All the NTT groups that
obtained such certification by imple-
menting the ISO/IEC 17799 concept
reaffirm that it is not a one-time only
counter-measure but that it is crucial to
maintain those management processes.”
Protection of information
within multiple fields
ISO/IEC 17799 addresses best
practice for the protection of informa-
tion applied, for example, to the Human
Resource department, operational sys-
tems and processing facilities, third
party services, business applications,
Internet services, business continuity,
and compliance with legislation. The
risks addressed by the best practice
specified in ISO/IEC 17799 apply to
most sectors of business ; this standard
thus provides a “ common language ”
for information security risk manage-
ment. Also the flexible design of the
standard enables it to be used by any
organizations of any size.
The telecommunications sec-
tor is a prime example of a major
user of information security to pro-
tect and manage a range of networks
and network services. ISO/IEC 17799
provides a framework for protecting
information systems, communications
and services deployed by this sector.
All organizations, both commercial
and governmental, rely in some way
or other on network services to carry
out their business. This dependability
means that security of these services
becomes a key aspect – hence the
take-up of the standard by many net-
work operators around the world that
clearly confirms its importance to the
sector. This is additionally borne out
by the active collaboration between
ISO/IEC and ITU-T on the future
development of this standard. Says
Dale Johnstone, Principal Consultant
Risk Management, PCCW, a leading
network operator in Hong Kong.
“ Security of information as
it is moved between computers and
networks has become a high priority
About the author
Ted Humphreys
s convenor of
he working
roup of ISO/
EC JTC 1/SC
7, IT security
echniques,
esponsible for
he maintenance
nd future devel-
pment of ISO/
IEC 17799 and other information security
management standards. He is also Director
and Founder of the ISMS International
User Group, the user community forum
for ISO/IEC 17799.
“ Australian business
and government depart-
ments commonly use
ISO/IEC 17799 to guide
in the implementation of
best practice information
security controls.”
in the business world – and is cru-
cially important to PCCW in protect-
ing its own, and customers’, informa-
tion assets. Applying ISO/IEC 17799
and attaining certification to the Brit-
ish standard BS 7799-2 (Part 2 of
ISO/IEC 17799, at present undergo-
Photo © ISO
ing development) demonstrates our
commitment to protecting information
in our possession, and establishes a
qualification that all IT&T companies
should strive to achieve. Increased pri-
vacy controls by governments in the
countries where PCCW operates is an
important issue. As legislation regulat-
ing how information is secured and
protected becomes increasingly com-
plex around the world, PCCW must be
positioned well to respond effectively
– and adoption of ISO/IEC 17799 and
BS 7799-2 enables the company to do
exactly that.”
Services provided
by third parties
Businesses around the world
depend upon services provided by
third parties, in particular their use in
a growing market for managed data
services. This type of business relies
heavily on information security for a
variety of information handling and
processing controls, ensuring the avail-
ability and continuity of information
services and many others for manag-
ing the risks related to the provision of
third party services. The following is a
view on this by one of the global busi-
nesses in this market.
Grant Geyer, Vice-President,
Global Managed Security Services,
Symantec Corporation, USA, com-
ments : “ Outsourcing critical infra-
structure, especially security, is not
a decision easily made by corpora-
tions. There is a need for providers to
not only deliver extremely high value
and quality, but more importantly, an
imperative to ensure our clients trust
how we’re running the business. Using
ISO/IEC 17799 has enabled Symantec
to provide our managed service cus-
tomers with the assurances they need
about our ability to secure their infor-
mation. Our customers can see that
ISO Focus July-August 2004 37
Developments and Initiatives
we use globally accepted best prac-
tice, with processes that they are able
to examine for themselves. Internally,
it has improved our management of
people, processes and technology and
has meant that information security is
ingrained in the way we work.”
Information security in
the financial sector
The banking institutions are a
well-established user of information
security whether it be the traditional
means of banking or the more modern
on-line banking deploying Internet
technology. Several banks around
the world are now also applying the
best practice in ISO/IEC 17799 ; these
include CITI Bank Asia Pacific, ING
Banking Group, Istituto Bancario San-
Paolo, Misys International Banking, to
name but a few. The Federal Reserve
Bank in New York has been one of the
more recent adopters of the ISO/IEC
17799 standard and, in addition, their
information security management sys-
tem based on this standard has under-
gone an independent third party audit.
Ruud Goudriaan, Corporate
Legal Compliance & Security, ING/,
that has adopted it as the basis for all
State Enterprise Information Security
Policies, and the State of Maine has
adopted it for all State Government
entities as their security policy. In
other countries, health authorities,
the criminal justice system, trade and
industry departments, police services,
social services and many more govern-
ment entities have adopted ISO/IEC
17799.
John Snare, Chair, Austra-
lian ISMS Users’ Group, express-
es his appraisal thus : “ Many busi-
ness and government organizations
know that they have unresolved infor-
mation security problems. However,
Legislation and
cost-effective and prioritized action
to bring these problems under con-
trol is a major challenge. Austra-
lian business and government depart-
partners in
ments commonly use ISO/IEC 17799
to guide in the implementation of best
practice information security controls.
consumer
The use of ISO/IEC 17799 is increas-
ingly being coupled with implementa-
protection
tion of a management system, based on
AS/NZS 7799.2, Information security
management – Specification for infor-
By Giles Allen, Editor
mation security management systems,
to prioritize implementation activi- of ISO Focus
ties and ensure that controls actually

Amsterdam, says : “ ING has decided
in an early stage (1997) to base their
Information Security Policies and
organization on the BS 7799. The
good foresight of that decision is dem-
onstrated by the approval in 2000 as
ISO/IEC standard and the worldwide
recognition as reference standard. ING
has implemented ISO/IEC 17799 based
policies in all its business units.”
Government agencies
need security also
The use of ISO/IEC 17799 is
not limited to businesses. Governments
have also taken to using the standard in
many different areas of their business.
This includes government agencies, in,
for example, Australia, Finland, Ger-
many, India, Japan, United Kingdom,
and the USA. There are states in the
USA that have adopted the standard,
as for example, the State of Georgia
achieve their intended objectives.”
A common language for
a best practice standard
ISO/IEC 17799 is proving to
be the global best practice standard
for information security. It has made
its mark as a “ common language ”, as
testified by the take-up by businesses
across a broad spectrum of market
sectors. This standard, like other
standards within ISO, is now going
through the regular revision process.
This is important to ensure that it
continues to remain the “ common
language ” for information security
providing best practice for the com-
mon good of all businesses worldwide
– irrespective of whether for the small,
medium or large market sector.
G
lobalization has rapidly created
a pressing need for a system
that protects the international
consumer in an effective way. To cre-
ate global regulations as such, howev-
er, is a virtually insurmountable chal-
lenge. Therefore a softer approach,
using the toolbox of instruments that
exists at present to their best effect and
in the correct doses already represents
notable progress in the right direction.
It was precisely the mix of
these tools that was at the heart of the
debates at the workshop “ Regulation,
Co-regulation and self-regulation
– who is at risk ? Legislation and
standardization – partners in consum-
er protection ” held in Prague, Czech
Republic, on 17 May, in conjunction
with the COPOLCO (ISO Committee
on consumer policy) plenary. Attended
by 100 delegates from 29 countries, the
workshop provided a good occasion to
look at the subtle inter-relations and
interaction between regulations and

38 ISO Focus July-August 2004


standards
standards, and how and where they can
help each other in a common cause of
protecting the consumer. For, as Ms.
Caroline Warne, Chair of COPOLCO
said, opening the workshop : “ There is
great concern abroad about the effect
on consumers of the shift towards a
less regulated environment.”
The issue of trust
There were notable differences
between developed, developing and
transitional economies, even if dis-
parities were getting less. Mr. Otakar
Kunc, Director of the Czech Standards
Institute said how pleased he was
about the holding of the workshop in
the new circumstances in the Czech
Republic, particularly as “ the recent
progression in consumer matters here
is promising for consumers and for
standardization.”
Mr. Josef Tržický, General
Director of the Section for Consumer
Protection and Internal Market of the
Ministry of Industry and Trade, Czech
Republic, saw in the heterogeneous
Forum the possibility of contributing
to a more efficient participation of con-
sumers in the creation of international
standards. “ The level of consumer
confidence,” he said, “ is directly pro-
portionate to their involvement in the
development of the standards.”
There was some way to go
before the European consumer felt
The beauty and
hospitality of a
renovated city
of Prague, with
its refound
confidence in the
future, proved the
ideal setting for a
reflection on con-
sumer issues of
particular import
and relevance
to economies in
transition as well
as to developing
countries.
Photo © ISO
really at ease in cross-border shopping
and, at the heart of everything was the
issue of trust – but that was only one
reason, among other more practical
and down-to-earth causes. The fol-
low-up of complaints handling, taking
a company in another country to court,
in a foreign language with different
laws was more than most Europeans
felt capable of undertaking with ease,
said Dr. Lothar Maier, President of
DIN Consumer Council. Shopping
outside a consumer’s country was
still the exception: 86 % of Europeans
had not shopped across borders in the
last year, yet a comparison of prices
between countries highlighted big
advantages. A bottle of mineral water
that could vary in price between the
different national outlets by 44 %; but
between countries of the Union, that
difference soared to 300 %.
The European Union is trying
to use the tool of standardization to
contribute to change the behaviour of
consumers in general and in cross-bor-
der shopping in particular. But, asked
Lothar Maier, is regulation, and what
sort of regulation, also necessary to
protect the consumer ? “ Self-regula-
tion is an option but always on the
condition of effective enforcement,”
he said. “ Co-regulation could be a
precious contribution to fair com-
mercial practices, but only on the
condition of the establishment of an
effective enforcement mechanism. The
results of entirely voluntary applica-
tion without effective enforcement are
discouraging.”
For the Czech Republic, that
had just integrated the European
Union, the question of new approach-
es to consumer protection was of
immediate relevance, as the country
adjusted itself to the new situation.
As explained by Mr. Libor Dupal,
Director of the Czech Consumer
Association, the present European con-
sumer policy covers a broad spectrum
of areas, with measures of a regulatory
nature as well as tools for voluntary
use (technical standards and self-regu-
lation instruments).
“ The voice of
the consumer
is critical to
achieving ISO’s
goals,” said
Oliver Smoot,
ISO President.
“ In ISO’s mis-
sion statement,
we make refer-
ence to ‘ global
relevance ’ ;
this includes
relevance to
consumers,
and looking for
globally
acceptable
solutions.”
Mr. Dupal claimed that one
of the most significant tools for the
implementation of the European
policy should be an effective applica-
tion of the alternative dispute resolu-
tion systems (ADR), including the
operation of the European Network
for Extra Judicial Settlement of con-
sumer disputes. ADR he defined as
“ amicable, out-of-court juridical dis-
pute resolution, used in most countries
on a voluntary basis, and dependent
on self-regulatory mechanisms and
principles ”. “ We have analysed the
situation in the Czech Republic and
the EU, and are trying to develop new
structures for the application of this
mechanism.” Mr. Dupal stressed how
ISO Focus July-August 2004 39
Developments
and Initiatives
keen he was that ISO keep up the work
in the areas of complaints handling
and dispute resolution initiated within
COPOLCO, and how to make ADR
attractive to both parties.
The consumer and
the tools available
Ms. Anna Fielder, Director
of the Office for Developed and
Transition Economies, Consumer
International, studied the notions of
regulation, self-regulation and co-
regulation, specifically in the context
of the transition economies. While
some 12 different definitions of “ self-
regulation ” existed, she retained three
broad categories which were voluntary
(where business regulates itself) and
delegated self-regulation where the
state delegates to a professional body
and provides it with a licensing sys-
tem. Finally there was co-regulation,
a hybrid system where the state sets
the framework, then industry chooses
to join in or not.
Historically the consumer
movement has been wary of the effec-
tiveness of self-regulation, considering
it as a helpful adjunct to state-led regu-
lation rather than an answer in itself.
This was because the necessary corol-
laries of effective regulation – follow-
up oversight, enforcement and redress
– have generally been lacking in
self-regulatory systems. In developed
economies, consumer organizations
themselves play an important function
in monitoring or forcing the market
to deliver – examples range from car
crash safety tests that exceed interna-
tional standards to setting up various
codes and schemes for effective serv-
ice delivery.
The situation was different in
transition economies : in the area of
product standards, for instance, they have
changed from a prior situation of strong-
ly regulated pre-market entry product
certification to one of “ presumption of
conformity ”, in order for the new mem-
bers to align with the EU system, and for
the developing economies to conform to
the principles laid out in the WTO Tech-
nical Barriers to Trade.
40 ISO Focus July-August 2004
Photo © ISO
“ Though consumers have
been sceptical about the use of self-
regulation essentially for the ‘ no teeth ’
reasons, we are coming to think that
hybrid or co-regulation is the form
most likely to deliver for consum-
ers ”, she said. “ We are also seeking
to encourage ISO to look at codes
for ‘ effective stakeholder representa-
tion ’.”
Closing the gap between
incompatibilities
For Dr. Elizabeth Nielsen,
Health Products and Food Branch
Health Canada, it has become virtually
unthinkable to reach an “ international
legislation,” so complex and divergent
are regulations at the national level.
Another means needed therefore to
be found to bring the world’s systems
nearer together and to close the gap
between incompatibilities between
national laws the world over. Since
International Standards are one of sev-
eral well-established tools that exist,
they can play an extremely useful role
in harmonizing and aligning systems
by playing a “ go-between ” role, and
getting legislations throughout the
world to pull together in the same
direction. For Elizabeth Nielsen, it was
preferable not to think of standards and
regulations as two separate species, but
as two in a range of interlocking tools
that were to be used in varying combi-
nations according to need and purpose.
Self-regulation has its sceptics,
convinced that rogue traders would deal
a final blow to ambient “ permissive-
ness ”. However it has its proponents
also : Professor Tsuneo Matsumoto,
Graduate School of Law, Hitotsubashi
University, Japan, described how
consumer protection is today consti-
tuted by “ soft law ” in Japan, made
up of various tools “ co-regulation ” or
“ self-regulation ”. Comparing various
national experiences, he considered
how such systems of self-regulation
or co-regulation successfully help
safeguard consumer interests by the
best mix of tools, according to country
and situation.
Consumers’ main concerns
relate to safety and health, lack of infor-
mation, fraud, inability to understand
complex transactions, and rational deci-
sions versus high-pressure sales tech-
niques. From the consumer perspective
it is particularly important to underpin
standards by effective state regulation.
“ There are many different
approaches to consumer protection,”
said Prof. Matsumoto, “ Government
legislation (regulation), cooperative
mechanisms between the public and
private sectors (co-regulation) and
voluntary adherence by businesses to
a code of ethics and self-declaration
of conformity, enforced by peers or
by independent consumer movements.
Standards have a role in all three sys-
tems.”
A long way to reassure
the consumer ?
Getting the consumer conscious
and involved in consumer protection
begins in education, said Ms. Nadežda
Klabusayová, who gave her experience
of teaching of quality and consumer
protection at the Department of Busi- ž
ness Administration of the University of
Ostrava (Czech Republic). Getting such
consumer demands into students’ ways
of thinking was a highly successful
way of later involvement and automatic
consumer reactions among tomorrow’s
leaders of opinion. Furthermore, quality
begins as a mindset which is best cul-
tivated early in life. Ms. Klabusayová
emphasized the importance of inculcat-
ing the quality ethic as a backdrop to
technical capability in business.
Despite the noticeable improve-
ment in the security of the Internet,
there was a long way to go before the
 consumer felt totally reassured. Was it
possible, asked Mr. Steven Cole, Senior
Vice-President, Council of Better
Business Bureaus, USA, to count on
the self-discipline of the trades-peo-
ple to ensure the Internet themselves,
since there was no enforcement ? Was
self-regulation an effective tool ? The
response varied, he said ; systems such as
the trustmark concept of shopping on the
internet with recognized and approved
traders, had has considerable success in
the USA ; trustmark programmes were a
three-legged stool, requiring high stand-
ards, accessible dispute resolution and
a trustmark. Not all the problems had
been solved, however, he said, such as
the issue of funding of systems, keeping
them independent and trusted. However,
argued Steven Cole, the trustmark con-
cept and global trustmark alliance are
timely and useful, despite some improve-
ments and issues to resolve, namely a
heightened focus on dispute resolution
implementation, a need to rethink forms
of self-regulation and the possible role
of international standard-setting from
organizations such as ISO. The Internet
and e-commerce companies are global,
whence a need for consistency, flexibil-
ity and high standards.
Breakout groups then tackled
themes of particular concern. Talking
about consumer participation, attend-
ees noted the greater reliance being
placed on standards at both national
and international level, but remarked
how it was growing even more difficult
to find and fund consumer representa-
tives, and looked at alternative funding
models. The added credibility, and
ž Standards Officer, TTSB, Trinidad and Tobago ;
thus value, given to standards devel-
oped with consumer input needed to
be constantly voiced. Participants sug-
gested that the development of a set of
criteria for participation, with further
benchmarking against such criteria,
and inclusion in the new ISO Business
Plans of a template with a clear fund-
ing mechanism for consumer represen-
tation could be a way forward.
Environmental issues were very
special case, and the second breakout
group recognized their importance but
stressed the need for political will to
address environmental concerns, that
were particularly difficult to imple-
ment for developing countries due to
the costs of certification. There was a
need for a mechanism to make envi-
ronmental standards more effective,
and to carry out a survey to study how
they were being implemented. This
concerned in particular the ISO 14020
series of standards that were not being
used sufficiently.
E-commerce, that theoretically
could open the world to consumers,
still suffered from the handicap of
the difficulty of access for develop-
ing countries, as well as an overdose
of information, with its accompany-
ing unreliability and the insecurity
involved in the transaction. The OECD
Guidelines on e-commerce was an
excellent start, and some good national
standards exist, but the group felt that
an ISO standard on e-commerce would
gain wider acceptance.
Standards – an indispen-
sable cog in the
regulatory mechanism
The workshop sought to explore
effective mechanisms by which vol-
untary standards interact with regula-
tory regimes to ensure that products and
services meet consumers’ expectations
for safety, performance, fitness of pur-
pose, pricing redress and other criteria.
In the course of the workshop,
the issue of enforcement was con-
stantly either present or in the wings.
Among the array of instruments exer-
cising varying degrees of “ constraint ”,
along with regulations and self-regula-
tions, came voluntary and consensus-
based International Standards, one of
the most useful of these tools. The
level of consensus that transcends
national frontiers that is provided by
ISO standards propels them forward as
actors on the international stage ; they
can credibly support national policy
goals and be relevant and useful in the
increasingly international market.
Speakers, moderators and rapporteurs at
the workshop, from left to right, top row to
bottom. Josef Tržický, General Director of the
Section for Consumer Protection and Internal
Market of the Ministry of Industry and Trade,
Czech Republic ; Bruce Farquhar, Consultant,
Canada ; Anne Ferguson, Vice Chair, Consumer
Representation in Standardization, British
Standards Institution (BSI-CPC) ; Otakar Kunc,
Director, Czech Standards Institute (CSNI),
Czech Republic; Caroline Warne, COPOLCO
Chair ; Naděžda Klabusayová, Associate
Professor, Technical University of Ostrava,
Department of Business Administration,
Czech Republic ; Second row : Steve Williams,
Herman Schipper, Head International and
European Affairs, NEN, Netherlands ; Tsuneo
Matsumoto, Japanese Consumer Council,
Graduate School of Law, Hitosubashi
University, Japan ; Bill Dee, Representative,
Standards Australia International ; Steven J.
Cole, Senior Vice President, General Counsel,
Council of Better Business Bureaus, USA ;
Libor Dupal, Director, Czech Consumer
Association, Czech Republic ; Bottom
row : Agnes Ratz-Ludanyi, MSZT, Hungary ;
Elizabeth Nielsen, Health Products and
Food Branch, Health Canada ; Anna Fielder,
Director, Office for Developed and Transition
Economies, Consumers International ; Dana
Kissinger, Secretary ISO/COPOLCO. Absent :
Lothar Maier, University of Applied Sciences,
President, DIN Consumer Council, Germany.
ISO Focus July-August 2004 41
Developments and Initiatives
been developed that would further
The unrelenting advance compress video. In 2001, a Call for
Evidence was issued asking the indus-

of video compression try to bring evidence that video could

By Leonardo Chiariglione, Digital
Media Strategist, Convenor of
ISO / IEC JTC 1 / SC 29 / WG 11,
the Moving Pictures Experts Group
(MPEG) working group
bound to get a solution. This was the
case of video compression. The prob-
lem was to reduce the number of bits/s
required to store or transmit video
signals. The smart people were the
thousands of researchers who invested
time and effort to reduce the bitrate of
be further compressed compared to
MPEG-4. The evidence confirmed the
validity of the request, and the decision
to develop a new part (part 10) of the
MPEG-4 standard – called Advanced
Video Coding (AVC) – was taken,
this time in collaboration with ITU-T
(as had been the case for MPEG-2).
ISO/IEC 14496-15:2004, Information

E
ver since people first realized
that digital technologies could
be used to store and transmit
video signals with greater fidelity, the
problem of the amount of bits required
to do so became apparent. The ana-
logue television signals still in com-
mon use today have a bandwidth of
about 5 MHz. Converted into bits, this
generates 216 Mbit/s (million bits per
second) some 20 times more than the
bitrate of a good ADSL modem !
Ask smart people to solve a
well-formulated problem and you are
digital video to low levels.
It did not happen overnight.
The first applications were driven
by the idea that people would like to
communicate with video in addition to
audio. In the early 1990s the first stan-
dard produced by the Moving Picture
Experts Group or MPEG (Working
Group 11 of ISO/IEC JTC 1/SC 29)
targeted storage of digital video on
compact disc (CD). MPEG-1, as the
standard is called, is used in hundreds
of millions of Video CD players.
In the mid-1990s, MPEG devel-
oped MPEG-2 that
Photo © ISO
technology – Coding of audio-visu-
al objects – Part 15 : Advanced Video
Coding (AVC), was approved as FDIS
in July 2003.
AVC – video compression
of the new generation
There is an understandable
tendency on the part of salesmen to
overstate the quality of their “ wares ” ;
MPEG could similarly boast the won-
ders of its new “ product ”. This is not,
however, what MPEG does for the
audio and video compression stan-
dards it develops. When a compression

is being used in
hundreds of mil- standard nears completion, “ verifica-
lions of digital tion tests ” are run, using sophisticated
television set top techniques that transform the results of
boxes and Digital a large number of subjective evalua-
Versatile Disc tions into objective measures. For AVC
(DVD) players. it was found that on average the com-
In the late 1990s,
MPEG developed
MPEG-4 that is
widely used to About the author
move digital video
Dr. Leonardo
files on the web, to
Chiariglione is
view video on cell Convenor of the
phones or to store Moving Pictures
digital video in a Experts Group
computer-friendly (MPEG), the
fashion. working group
All these which produced
standards were the MPEG-1,
characterized by MPEG-2 and
advances in the MPEG-4 stand-
ards that support rich-media applications
technologies used
on diverse delivery systems, MPEG-7, that
to compress video
supports advanced search and retrieval of
signals. In 2000, audio-visual content and is developing
MPEG started MPEG-21, the Multimedia Framework
inquiring if new and MPEG-A, the MultimediaApplication
technologies had Formats.

42 ISO Focus July-August 2004

pression performance of AVC is twice
that of MPEG-2 and MPEG-4 part 2
(the original MPEG-4 standard).
This is an impressive result
and there is a lot of excitment in the
industry at the possibilities opened
up by this new standard. AVC can
be used in at least two new ways : to

Photo © ISO
replace older standards for the same
type of application or to use the new
standard for new applications. One
of the possibilities of the former is
to use AVC as the video compres-
sion of the new generation DVD that
is being discussed in the appropriate
ISO to go ahead
fora. Another is to use AVC to pro-
vide improved picture quality on such
constrained-bandwidth applications as
with guidelines for social
video on mobile devices.
When a new technology replac-
es an old one in widely deployed appli-
responsibility
cations and devices there is always
some resistance because of the need By Roger Frost, Press and Communication Manager,
to cater for the transition between the ISO Central Secretariat
old and the new. This is not, however,

I
SO is to develop an International ISO system, ISO recognizes that the
the case for new applications, such as
Standard for social responsibility. work will need to be carried out “ in an
digital video on the Internet, for which
The objective is to produce “ a innovative manner ”, but insists that this
there have been little more than trials.
guidance document, written in plain remains “ consistent with ISO’s funda-
AVC can be the video compression
language which is understandable and mental principles ”, including openness
technology of choice – along with
usable by non-specialists ” and not and transparency in the way it works.
another successful MPEG technol-
intended for use in certification. ISO Secretary-General Alan
ogy for audio compression, Advanced
The decision was taken at a sen- Bryden commented : “ ISO’s decision is
Audio Coding (AAC) for what is likely
ior ISO management meeting on 24-25 based on a thorough analysis of trends
to become the marriage between net-
June 2004 in Stockholm, following an and initiatives relating to social respon-
works and media.
international conference in the Swedish sibility and the active involvement of all
Is this the end of the story for
capital earlier the same week on 21- interested groups of stakeholders. The
video compression ? Most likely not.
22 June. The conference provided a consensus achieved on the way forward
In December 2003, MPEG issued a
platform for stakeholders to give their for an ISO contribution illustrates the
Call for Proposals for video compres-
views on whether ISO should proceed broadening of the scope of our work
sion technologies with “ scalable ”
with work addressing the social respon- and the recognition that today, ISO not
features, and in March 2004 received
sibility (SR) of organizations and, if so, only provides a growing portfolio of
a large number of responses. MPEG
what form it should take. technical standards, but may also sup-
is now busy working on a new video
Based on the consistent and ply solutions and guidance on social
compression standard that is expected
supportive feedback from the confer- and environmental issues in the global
to see the light toward the end of
ence, ISO concluded that a further fea- economy. This new venture is obvious-
2006.
sibility study was unnecessary and that ly of great interest to stakeholder groups
Get ready for more compression
SR work should be “ undertaken imme- such as consumers, NGO’s, labour and
with more features !
diately ”. In taking its decision, ISO regulators whose participation and input
acknowledges that “ social responsibil- ISO both needs and values.”
ity involves a number of subjects and To develop the SR standard,
issues that are qualitatively different ISO will set up a new working group
from the subjects and issues that have answering directly to ISO’s Technical
traditionally been dealt with by ISO. ” Management Board (TMB) that over-
Since developing an SR stand- sees the activities of the organization’s
ard will bring new and more varied 186 standards-developing technical sub-
categories of stakeholders into the committees. As a first step, it has formed
ISO Focus July-August 2004 43

Ms. Ziva Patir, ISO Vice-President
(technical management).
a task force to propose the terms of ref-
erence and operating processes for the
working group in time for consideration
at the TMB meeting in September 2004.
Even before that date, the
national standards institutes that com-
prise ISO’s worldwide membership are
being asked to submit by 15 August
2004 their candidates for a twinned
leadership and secretariat to the SR
working group, linking developed and
developing countries. The experts to
the working group will be appointed by
the ISO members from all stakeholder
categories. Related international and
broadly based regional organizations
will also be able to appoint experts.
Easier participation for
experts from developing
countries
ISO intends to make it easier for
experts from developing countries to
participate, as well as from other stake-
holder categories with limited resources,
such as nongovernmental organizations,
consumer associations and others. A post
will be created within the working group
specifically to deal with stakeholder par-
ticipation, including funding.
In deciding to develop an SR
guidance standard, ISO emphasizes that
it is intended to add value to, and not
to replace, existing inter-governmental
agreements with relevance to social
responsibility, such as the United Nations
Universal Declaration of Human Rights,
and those adopted by the International
Labour Organization (ILO), and other
UN conventions. Furthermore, it recog-
nizes the need to develop an agreement
with ILO on cooperation between the
two organizations in the area of social
responsibility.
44 ISO Focus July-August 2004
Crown Princess Victoria of Sweden, who
officially opened the ISO conference on social
responsibility in Stockholm, is presented with
a bouquet by Swedish Standards Institute
(SIS) Chair Håkan Murby.
The ISO SR conference, which
was hosted by the Swedish Standards
Institute (SIS), drew 355 participants
from 66 countries, including 33 develop-
ing countries, representing the principal
stakeholder groups : business, govern-
ment, labour, consumers, international
and nongovernmental organizations.
The major focus for discussion at
the conference was provided by the work
of the advisory group (AG) on social
responsibility which ISO had set up in
early 2003 to help it decide on even-
tual involvement in SR. The group had
developed an extensive report including
an overview of SR initiatives worldwide
identifying issues that should be taken
into account by ISO. It had concluded
that ISO should go ahead with work on
SR on condition that a set of key recom-
mendations are met. On the day after the
conference, ISO met the AG to discuss
the conference feedback and review the
report and recommendations.
At its own meeting on 24-25
June, ISO basically accepted the AG’s
recommendations and addresses them
in its resolution 35/2004 to launch ISO
work on SR that takes fully into account
the elements identified by the AG in its
report and by other stakeholders at the
conference.
Daniel Gagnier, Chair Advisory Group on Social
Responsibility, and Senior Vice-President,
External and Corporate Affairs, Alcan Inc.
Lars Flink, Managing Director, Swedish
Standards Institute (SIS), hosts to the
conference.
The full resolution can be con-
sulted on the SR conference Web site
created by ISO, along with the presen-
tations made at the event, conference
photos and the AG’s report and recom-
mendations. For the future, ISO will
consider developing a Web site as a
means of disseminating good practice in
the field of social responsibility.
Considering that the AG has
successfully completed its mission, ISO
has now disbanded the group, thanking
it and its Chair, Daniel Gagnier, Senior
Vice-President, External and Corporate
Affairs, Alcan Inc., for their achieve-
ments.
ISO Deputy Secretary-General
Kevin McKinley commented : “ The
extent to which the issues raised by
the different stakeholder groups at the
Stockholm conference mirrored those
identified in the AG’s report confirms the
value of the work it has carried out for
ISO over an 18-month period. Now it is
up to ISO to address these issues and face
the challenge
of develop-
ing practical
guidelines that
benefit all the
stakeholders in
social respon-
sibility.”
Kevin McKinley,
ISO Deputy
Secretary-
General.
Photos by Måns Diedrichs, Corporate
Communications, Swedish Standards
Institute (SIS).
Coming up
Main Focus
Food technologies
The ISO Focus dossier on food techno-
logies brings together the essence of
what is happening in standardization in
the varied and heterogeneous aspects of
the food industry.
In each country, the purveyance to its
population of food in sufficient quantity,
of suitable quality and with inherent
safety is a basic political requirement of
that country, and thus the production, the
possible export, and the necessary
import of food represent a prime focus
of interest universally. International stan-
dardization in the agriculture and food
areas started in 1947, and today ISO
today has some 640 standards “ under its
belt ” in the field.
ISO/TC 34, Food products, serves as a
platform for developing ISO Internatio-
nal Standards, and harmonizing the rela-
tions with those of other international
organizations such as the CODEX Ali-
mentarius Commission and the Interna-
tional Dairy Federation.
The most frequent demand to ISO/TC
34 and its subcommittees is to develop
International Standards related to analy-
sis and test methods, and approximately
65 % of standards cover such methods.
Most product-orientated subcommittees
of TC 34 have developed one or more
standards for sampling of their products.
Another important area : ISO’s vocabula-
ry standards are comprehensively used
in world trade and are accepted by other
international organizations.
Photo © ISO
“ Chemicalization ” of agriculture and
the food industry has significantly
increased the yields and food produc-
tion. However, with it has come a
widespread fear of chemicals, and the
demand is rising for more effective
agricultural technologies, that maintain
the nutritive value of the raw materials,
and that preserve the environment.
Food safety has become a universal
and absolute demand. In view of this,
the trend of work is changing with
respect to transgenic materials, new
molecular biological methods, markers,
techniques and technologies. Changes
are expected due to the need to
describe novel qualitative and quanti-
tive methods for the detection of
Genetically Modified materials, and to
follow them in food, in human organ-
isms and in the environment.
TC 34’s work, that covers all the “ tradi-
tional ” fields (cereals, tea and coffee,
milk and milk products, meat and
poultry, fruits and vegetables, edible fats
and oils, etc.), now tackles new and spe-
cific challenges in regard to genetically
modified organisms (GMOs) and tracea-
bility in the food chain. Good Manufac-
turing Practice has become a must for
the industry and consumers : ISO is fina-
lizing ISO 22000, Food safety manage-
ment systems – Requirements throughout
the food chain. And in the light of the
accidents such as dioxin spills and the
BSE (Bovine Spongiform Encephalopa-
thy or “ Mad Cow Disease ”) affair, the
need for International Standards for
methods of analysis for feed are growing.
Developments and
Initiatives
Standards of practice in dentistry.
In the last decade, ISO/TC 106, Dentis-
try’s work has increased substantially,
with new work items demanding both
new standards and the revision of exis-
ting specifications, mainly due to the
flood of new products and clinical
techniques. Three main trends are res-
ponsible : firstly, public appreciation of
the importance of good teeth to a
youthful and aesthetic appearance ;
Photo © ISO
secondly, the increasing desire for cos-
metic or aesthetic dentistry which invol-
ves minimal size fillings and tooth-
coloured filling materials such as poly-
mer-ceramic composites and ceramics.
Thirdly, the exponential increase in the
use of titanium implants embedded in
the jaws as a foundation for the replace-
ment of a missing tooth or teeth.
A world of applications for gas
calibration. The work of ISO/TC 158,
Analysis of gases, is mainly concerned
with the calibration of gases and gas
mixtures, and its market is that of the
calibration of gas market, although the
direct influence of what it does affects
the whole gas market. Photo © ISO
All gas analysing equipment needs cali-
bration, and these standards have a big
impact on a wide range of applications
where accurate knowledge of gas mixtu-
re composition is required. This can be
for demonstration of compliance with
regulations, for trade purposes, for
industrial purposes, or for environmental
purposes.
ISO Focus July-August 2004
Whether it’s Autumn or Spring
in your region...
...the environment is global.
14 001
ISO

ISO 1
4004

Coming this Winter (or Summer),

the revised ISO 14001* and ISO 14004*.
The global EMS standards.
www. .org
* Already available as FDIS (Final Draft International Standards)