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What are standards?
Standards are documented agreements containing technical
specifications or other precise criteria to be used
consistently as rules, guidelines, or definitions of
characteristics, to ensure that materials, products,
processes and services are fit for their purpose.
For instance, the format of the credit cards, phone
cards, and "smart" cards that have become commonplace is
derived from an ISO International Standard. Adhering to
the standard, which defines such features as an optimal
thickness (0,76 mm), means that the cards can be used
worldwide.
International Standards thus contribute to making life
simpler, and to increasing the reliability and
effectiveness of the goods and services we use.
Why is international standardization
needed?
The existence of non-harmonized standards for similar
technologies in different countries or regions can
contribute to so-called "technical barriers to trade".
Export-minded industries have long sensed the need to
agree on world standards to help rationalize the
international trading process. This was the origin of
the establishment of ISO.
International standardization is well-established for
many technologies in such diverse fields as information
processing and communications, textiles, packaging,
distribution of goods, energy production and
utilization, shipbuilding, banking and financial
services. It will continue to grow in importance for all
sectors of industrial activity for the foreseeable
future.
The main reasons are:
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Worldwide progress in trade
liberalization
Today's free-market economies increasingly encourage
diverse sources of supply and provide opportunities
for expanding markets. On the technology side, fair
competition needs to be based on identifiable,
clearly defined common references that are
recognized from one country to the next, and from
one region to the other. An industry-wide standard,
internationally recognized, developed by consensus
among trading partners, serves as the language of
trade. |
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Interpenetration of sectors
No industry in today's world can truly claim to be
completely independent of components, products,
rules of application, etc., that have been developed
in other sectors. Bolts are used in aviation and for
agricultural machinery; welding plays a role in
mechanical and nuclear engineering, and electronic
data processing has penetrated all industries.
Environmentally friendly products and processes, and
recyclable or biodegradable packaging are pervasive
concerns. |
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Worldwide communications
systems
The computer industry offers a good example of
technology that needs quickly and progressively to
be standardized at a global level. Full
compatibility among open systems fosters healthy
competition among producers, and offers real options
to users since it is a powerful catalyst for
innovation, improved productivity and cost-cutting.
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Global standards for emerging
technologies
Standardization programmes in completely new fields
are now being developed. Such fields include
advanced materials, the environment, life sciences,
urbanization and construction. In the very early
stages of new technology development, applications
can be imagined but functional prototypes do not
exist. Here, the need for standardization is in
defining terminology and accumulating databases of
quantitative information. |
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Developing countries
Development agencies are increasingly recognizing
that a standardization infrastructure is a basic
condition for the success of economic policies aimed
at achieving sustainable development. Creating such
an infrastructure in developing countries is
essential for improving productivity, market
competitiveness, and export capability. |
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Industry-wide standardization is a
condition existing within a particular industrial sector
when the large majority of products or services conform
to the same standards. It results from consensus
agreements reached between all economic players in that
industrial sector - suppliers, users, and often
governments. They agree on specifications and criteria
to be applied consistently in the choice and
classification of materials, the manufacture of
products, and the provision of services. The aim is to
facilitate trade, exchange and technology transfer
through:
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• enhanced
product quality and reliability at a reasonable
price;
• improved health, safety and environmental
protection, and reduction of waste;
• greater compatibility and interoperability of
goods and services;
• simplification for improved usability;
• reduction in the number of models, and thus
reduction in costs;
• increased distribution efficiency, and ease of
maintenance. |
Users have more confidence in
products and services that conform to International
Standards. Assurance of conformity can be provided by
manufacturers' declarations, or by audits carried out by
independent bodies.
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What is ISO?
The International Organization for
Standardization (ISO) is the specialized
international agency for standardization
comprising of worldwide federation of national
standards bodies from more than 140 countries,
one from each country.
ISO is a non-governmental organization
established in 1947. The mission of ISO is to
promote the development of standardization and
related activities in the world with a view to
facilitating the international exchange of goods
and services, and to developing cooperation in
the spheres of intellectual, scientific,
technological and economic activity. ISO's work
results in international agreements, which are
published as International Standards.
ISO is made up of approximately 180 Technical
Committees. Each Technical Committee is
responsible for one of many areas of
specialization ranging from asbestos to zinc.
The purpose of ISO is to promote the development
of standardization and related world activities
to facilitate the international exchange of
goods and services, and to develop cooperation
in intellectual, scientific, technological, and
economic activity. The results of ISO technical
work are published as international standards.
The standards discussed here are a result of
this process.
How ISO got it’s name
Many people will have noticed a seeming lack of
correspondence between the official title when
used in full, International Organization for
Standardization, and the short form, ISO.
Shouldn't the acronym be "IOS"? Yes, if it were
an acronym – which it is not.
In fact, "ISO" is a word, derived from the Greek
isos, meaning "equal", which is the root of the
prefix "iso-" that occurs in a host of terms,
such as "isometric" (of equal measure or
dimensions) and "isonomy" (equality of laws, or
of people before the law).
From "equal" to "standard", the line of thinking
that led to the choice of "ISO" as the name of
the organization is easy to follow. In addition,
the name ISO is used around the world to denote
the organization, thus avoiding the plethora of
acronyms resulting from the translation of
"International Organization for Standardization"
into the different national languages of
members, e.g. IOS in English, OIN in French
(from Organization international de
normalization). Whatever the country, the short
form of the Organization's name is always ISO.
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How the ISO 9000 series standards
was developed ?
International standardization began in the
Electrotechnical field: the International
Electrotechnical Commission (IEC) was created in
1906. Pioneering work in other fields was carried
out by the International Federation of the National
Standardizing Associations (ISA), which was set up
in 1926. The emphasis within ISA was laid heavily on
mechanical engineering.
ISA's activities ceased in 1942, owing to the Second
World War. Following a meeting in London in 1946,
delegates from 25 countries decided to create a new
international organization "the object of which
would be to facilitate the international
coordination and unification of industrial
standards". The new organization, ISO, began to
function officially on 23 February 1947.
The first ISO standard was published in 1951 with
the title, "Standard reference temperature for
industrial length measurement". ISO Technical
Committee 176 (ISO/TC176) was formed in 1979 to
harmonize the increasing international activity in
quality management and quality assurance standards.
This committee developed quality systems
standards--the result being the ISO 9000 series,
published in 198
How ISO touched our life
ISO has touched our life in so many ways, even
though some of us are not aware about it. Below are
some examples of ISO standards that have been widely
adopted, giving clear benefits to industry, trade
and consumers worldwide.
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Standardization of the
format of telephone and banking card: ISO set a
standard size for the telephone cards and
banking cards (ATM cards, credit cards) the
cards can be used worldwide. |
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Standardization of Paper
sizes: The original standard was published by
DIN in 1922. Now used worldwide as ISO 216,
standard paper sizes allow economies of scale
with cost benefits to both producers and
consumers. |
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ISO film speed code: The ISO
film speed code, among many other photographic
equipment standards, has been adopted worldwide
making things simpler for the general user. |
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Quality assurance in
business: Tens of thousands of businesses
are implementing ISO 9000, which provides a
framework for quality management and quality
assurance. The ISO 14000 series provides a
similar framework for environmental management. |
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Standardization of freight
container: The internationally standardized
freight container enables all components of a
transport system - air and seaport facilities,
railways, highways, and packages - to interface
efficiently. This, combined with standardized
documents to identify sensitive or dangerous
cargoes makes international trade cheaper,
faster and safer. |
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Standardization of universal
system of measurement: m, kg, s, A, K, mol, cd
are the symbols representing the seven base
units of the universal system of measurement
known as SI (Système international d'unités).
The SI system is covered by a series of 14
International Standards. Without these standards
shopping and trade would be haphazard and
technological development would be handicapped.
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Standardization of symbols
for automobile controls: A well-designed symbol
conveys a clear-cut message in a multilingual
world. The same symbols for automobile controls
are displayed in cars all over the world, no
matter where they are manufactured. |
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Standardization of Safety of
wire ropes: used on oil rigs, on fishing
vessels, in mines, in all types of building
operations, for lifts and cable cars, etc. ISO
International Standards systematically define
basic characteristics such as size, surface
finish, type of construction, tensile grade of
the wire, minimum breaking load and linear mass.
Standardization of performance or safety
requirements ensures that user requirements are
met while allowing individual manufacturers the
freedom to design their own solutions for
meeting these basic needs. Consumers then
benefit from the effects of competition among
manufacturers. |
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Standardization of
international codes for country names,
currencies and languages: The ISO international
codes for country names, currencies and
languages help to eliminate duplication and
incompatibilities in the collection, processing
and dissemination of information. As
resource-saving tools, universally
understandable codes play an important role in
both automated and manual documentation. |
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Standardization of screw
threads: The diversity of screw threads for
identical applications used to represent an
important technical obstacle to trade. It caused
maintenance problems, and lost or damaged nuts
or bolts could not easily be replaced. A global
solution is supplied in the ISO standards for
ISO metric screw threads. |
Who makes up ISO?
ISO is made up of its members, which are divided
into three categories:
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Member body: A member body of
ISO is the national body "most representative of
standardization in its country". Thus, only one
body in each country may be admitted to
membership of ISO. Member bodies are entitled to
participate and exercise full voting rights on
any technical committee and policy committee of
ISO. |
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Correspondent member: A
correspondent member is usually an organization
in a country, which does not yet have a fully
developed national standards activity.
Correspondent members do not take an active part
in the technical and policy development work,
but are entitled to be kept fully informed about
the work of interest to them. |
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3)
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Subscriber membership: ISO
has also established a third category,
subscriber membership, for countries with very
small economies. Subscriber members pay reduced
membership fees that nevertheless allow them to
maintain contact with international
standardization. |
What are the ISO
9000 series
standards?
ISO 9000 is a series of quality management systems
standards created by the International Organization
for Standardization (ISO). The ISO 9000 quality
management systems (QMS) standards are not specific
to products or services, but apply to the processes
that create them. The standards are generic in
nature so that they can be used by manufacturing and
service industries anywhere in the world. First
released in 1987 and revised in a limited manner in
1994, they underwent a major overhaul in 2000.
The most important revised standard, ISO 9001:2000,
uses a simple process-based structure, which is more
generic than the old 20-element structure of ISO
9001:1994, is consistent with the plan-do-check-act
improvement cycle used in the ISO 14000
environmental management systems standards, and
adopts the process management structure widely used
in business today.
ISO9001:2000 is an internationally recognized
management standard that gives an outward sign to
customers, shareholders, and other interested
parties that you manage your organization with,
sound business objectives, have good control, and
have in place a structure for continual improvement.
The main thrust is to increase customer
satisfaction.
To achieve ISO9001:2000 certification your
organization will need to implement the relevant
elements of the standard into its management
structure and then be assessed by a third party
assessing body. The assessing body will make sure
that the standard has been implemented, ie: through
your documented processes and procedures, and then
they will check to make sure you are following them.
A successful audit by the assessing body will result
in the issuing of a certificate. In order to
maintain certification the assessing body will visit
you either once or twice a year (usually once for
small companies) to make sure you are maintaining
the ISO9001:2000 requirements.
ISO 9001:2000 addresses an organization’s quality
management system requirements, in order to
demonstrate its capability to meet customer
requirements, and applies to all generic product
categories, such as hardware, software, processed
materials and services.
ISO 9001:2000 registration gives the organization
the benefit of an objectively evaluated and enforced
quality management system. It is a tangible
expression of a firm’s commitment to quality that is
internationally understood and accepted. ISO
9001:2000 registration is carried out by registrars,
accredited organizations that review the
organization’s quality manual and other
documentation to ensure that they meet the standard,
and audit the firm’s processes to ensure that the
quality management system described in the
documentation is in place and is effective.
The ISO 9000 series is a set of five individual, but
related, international standards on quality
management and quality assurance. They are generic,
not specific to any particular products. They can be
used by manufacturing and service industries alike.
These standards were developed to effectively
document the quality system elements to be
implemented in order to maintain an efficient
quality system in your company. The ISO 9000 Series
standards do not themselves specify the technology
to be used for implementing quality system elements.
What are most common benefits of implementing the
standards?
Companies implementing the standards cite these
benefits:
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more consistent quality in
your product or service and fewer costly
after-the-fact inspections, rework and field
failures. |
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increased customer confidence
in your company's ability to consistently
satisfy their needs. |
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reduced frequency of audits
customers perform on your operation.
Increasingly, customers are accepting supplier
quality system registration from an accredited
third-party assessment based on these standards. |
Also See
Benefits of ISO
How ISO touched our life
How does the Series work?
ISO 9000 provides the user with guidelines for
selection and use of ISO 9001, 9002, 9003 and 9004.
ISO 9001, 9002, and 9003 are quality system models
for quality assurance.
These three models are actually successive subsets
of each other.
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ISO 9001 is the most comprehensive--covering
design, manufacturing, installation, and
servicing systems. |
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ISO 9002 covers production and installation. |
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ISO 9003 covers only final product inspection
and test. |
These three models were developed for use in
contractual situations such as those between a
customer and a supplier. ISO 9004 provides
guidelines for internal use by a producer developing
its own quality system to meet business needs and
take advantage of opportunities.
The choice of which model to implement depends on
the scope of your operation. For example, if you
design your own product or service, you must
consider ISO 9001. If you only manufacture (working
off someone else's design) you may wish to consider
ISO 9002. Finally, if you neither design nor
manufacture, you may wish to consider ISO 9003.
How does ISO 9000 define quality?
ISO 9000 define quality as “the degree to which a
set of inherent characteristics fulfills
requirements” (ISO DIS 9000:2000). In short, quality
is meeting our customer's requirements.
What is the definition of "quality system" as
referred to by ISO 9000?
A quality system is the set of business and quality
practices our company uses to ensure that we
consistently meet our customer's requirements.
Who is using the standards?
Corporations around the globe have built and
continue to build their quality systems around these
standards. Both large and small companies with
international businesses perceive the ISO 9000
series as a route to open markets and improved
competitiveness. You don't have to be a
multinational corporation or have business overseas
to benefit from implementing these standards in your
company.
Are the standards readily understood?
The standards were designed to be user-friendly.
They are generic in nature and follow a logical,
easily understood format. However, each company is
unique and there may be wide differences in
companies' readiness to implement the standards.
Where can I learn how to interpret and implement
the standards?
QIE offers public seminars and training program's on
understanding and implementing the standards. A good
place to start is our course:
• Getting Started with ISO 9000--A Baseline Workshop
We can train your personnel or actually assist with
implementing the standards.
How much will it cost and how long will it take
to implement these standards?
Unfortunately there is no set answer. Each company
is different. The answer really depends on how
developed your present system is and the
implementation strategy you adopt.
If my company is not registered as complying with
IS0 9000 quality system standards, does it mean that
we will not be able to sell our products globally?
ISO 9000 registration is not a legal requirement for
access to foreign markets, but it can be beneficial.
In the European Union (EU) for many regulated
products, ISO 9000 registration is an alternative
for product certification, not an absolute
requirement. In fact, as cited in most EU
legislation, quality system registration is neither
mandatory--there are other paths to product
certification--nor is it a stand-alone procedure.
Manufacturer compliance with either EN 29002 or
29003 is usually combined with product type testing
at the design stage for full certification to EU
legal requirements. Manufacturers interested in the
European markets need to review relevant EU product
safety directives available from the U.S. Department
of Commerce for specifics applicable to their
product area.
Outside of regulated product areas (such as medical
products), the importance of ISO 9000 registration
as a competitive market tool varies from sector to
sector. For instance, in some sectors, European
companies may require suppliers to attest that they
have an approved quality system in place as a
condition for purchase. This could be specified in
any business contract. ISO 9000 registration may
also serve as a means of differentiating "classes"
of suppliers, particularly in high-tech areas, where
high product reliability is crucial. In other words,
if two suppliers are competing for the same
contract, the one with ISO 9000 registration may
have a competitive edge with some buyers. Sector and
product areas where purchasers are more likely to
generate pressure for ISO 9000 registration include
aerospace, autos, electronic components, measuring
and testing instruments, and so on. ISO 9000
registration may also be a competitive factor in
product areas where safety or liability are
concerns.
How long is a registration valid?
The accredited third-party registrar will perform
periodic surveillance to assure that your quality
system is being maintained. Many registrars also
require a full re-audit after a specified time
(typically three or four years). If you fail to
maintain your quality system, the registrar will
suspend or cancel your registration.
If I decide IS0 9001 registration is
strategically right for our business, how do I
choose a competent registrar?
There are many factors that will affect your choice
of a registrar, such as: what is their mutual
recognition status, are they knowledgeable in my
industry as well as in auditing quality systems, how
many similar firms have they registered, what is
re-audit schedule and does it complement our
business cycle, and, most important, are they
accredited.
Your selection of an accredited registrar won't
automatically guarantee access to all global
markets, but it is the best way to ensure that you
have a competent registrar whose methods of
operation and qualifications have been subjected to
intense scrutiny, with the full weight of the ANSI
due process system behind it. It can give you
assurance that the dollars you invest in this
decision are spent wisely.
What is the future of
ISO 9000?
In order for the ISO 9000 family to maintain
its effectiveness, the standards are
periodically reviewed in order to benefit from
new developments in the quality management
field and also from user feedback. ISO/TC 176,
which is made up of experts from businesses
and other organizations around the world,
monitors the use of the standards to determine
how they can be improved to meet user needs
and expectations when the next revisions are
due in approximately five years' time.
ISO/TC 176 will continue to integrate quality
assurance, quality management, sector specific
initiatives and various quality awards within
the ISO 9000 family.
ISO's commitment to sustaining the ISO 9000
momentum through reviews, improvement and
streamlining of the standards guarantees that
your investment in ISO 9000 today will
continue to provide effective management
solutions well into the future.
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