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About ISO

ISO (International Organization for Standardization) is the world's largest developer


and publisher of International Standards. ISO is a network of the national standards
institutes of 163 countries, one member per country, with a Central Secretariat in
Geneva, Switzerland, that coordinates the system. ISO is a non-governmental
organization that forms a bridge between the public and private sectors. ISO has
developed over 18,500 International Standards on a variety of subjects and some 1100
new ISO standards are published every year. The three official languages of the ISO
are English, French, and Russian. The organization's logos in two of its official
languages English and French. The organization which today is known as ISO began in
1926 as the International Federation of the National Standardizing Associations (ISA)
ISO is a voluntary organization whose members are recognized authorities on
standards, each one representing one country. The bulk of the work of ISO is done by
the 2700 technical committees, subcommittees, and working groups. Each committee
and subcommittee is headed by a Secretariat from one of the member organizations.

History of ISO
The conference of national standardizing organizations which established ISO
took place in London from 14 to 26 October, 1946. ISO was born from the union of two
organizations .One was the ISA (International Federation of the National Standardizing
Associations), established in New York in 1926, and administered from Switzerland. The
other was the UNSCC (United Nations Standards Coordinating Committee), established
only in1944, and administered in London. Despite its transatlantic birthplace, the ISA’s
activities were mainly limited to continental Europe and it was therefore predominantly a
“metric” organization. The standardizing bodies of the main “inch” countries, Great
Britain and the United States, never participated in its work, though Britain joined just
before the Second World War. The legacy of the ISA was assessed in a speech by one of
the organization’s founders, Mr. Heiberg from Norway, at an ISO General Assembly in
1976. On the negative side, he admitted that the ISA “never fulfilled our expectations”
and “printed bulletins that never became more than a sheet of paper”. On the other hand,
he pointed out that the ISA had served as a pro to type. Many of ISO ’s statutes and rules
of procedure are adopted from the ISA, and of the 67 Technical Committees which ISO
set up in 1947, the majority were previously ISA committees. The ISA was run by a Mr
Huber-Ruf, a Swiss engineer who administered the organization virtually single-
handedly, handling the drafting, translation and reproduction of documents with the help
of his family from his home in Basle. He attempted to keep the ISA going when the war
broke out in 1939, but as international communication broke down, the ISA president
mothballed the organization. The secretariat was closed, and stewardship of the ISA was
entrusted to Switzerland.
Though the war had brought the activities of one international standardization
organization to an end, it brought a new one into being. The UNSCC was established by
the United States, Great Britain and Canada in 1944 to bring the benefits of
standardization to bear both on the war effort and the work of reconstruction. Britain’s
ex-colonies were individual members of the organization; cont i n e n tal countries such
as France and Belgium joined as they were liberated . Membership was not open to Axis
countries or neutral countries. The UNSCC was administered from the London offices of
an international standardization organization which was already venerable – the
International Electro technical Commission (IEC). The IEC was founded in 1906. Its
Secretary at the time of the Second World War was a British engineer called Charles Le
Maistre.Le Maistre has some claim to be known as the father of international stand a rd
ization. He played a significant role in the history of many org a n i za t i o n s
. As well as being involved in the IEC since 1906, it was he who initiated the series
of meetings which led to the founding of the ISA at the New York conference in
1926. Already in his 70 s, he also took on the job of Secre ta r y - G e n e ral of the
UNSCC, doubling this post up with his IEC duties. One of the IEC secretaries at the
end of the war was Miss Jean Marshall (now the wife of Roger Maréchal, inter-vie wed
later in this book). She describes Le Maistre as: “...an extraordinary man.
The conference of the national sta n d a rds bodies at which it was decided to establish ISO to o k
place at the Institute of Civil Engineers in London from 14 to 26 October 1946. Twenty-
five countries were represented by 65 delegates.

STAGES OF ISO

• International Standards are developed by ISO technical committees (TC) and


subcommittees(SC) by a process with six steps:
• Stage 1: Proposal stage
• Stage 2: Preparatory stage
• Stage 3: Committee stage
• Stage 4: Enquiry stage
• Stage 5: Approval stage
• Stage 6: Publication stage

• Stage 1: Proposal
– A proposal is submitted to ISO by industry members who feel that an
International Standard is needed for
their product or service. ISO forms technical committees (TC) and subcommittees
(SC) to discuss the
proposal. The committees vote on the proposal, and if the vote is accepted the
standard moves to the
second stage.
• Stage 2: Preparatory
– A group of experts is gathered by the TCs and SCs formed in the proposal stage
and is put under the charge
of a project chairman. The experts pen and revise a working draft of the standard
that outlines the
technical specifications that must be met by the standard. Once the experts are
satisfied with the technical
draft of the specification, the document is sent to the parent committee of the
group for review.
• Stage 3: Committee
– The working draft created during the preparatory stage is registered by the
Central Secretariat of ISO and
circulated among the TC and SC groups formed for the standard. The committees
reviewing the draft can
vote to send the document to the next stage as a draft International Standard or
revise the document .
• Stage 4: Enquiry
– The draft International Standard (DIS) is circulated among the member bodies of
ISO for review, voting and
comment. Member bodies have five months to respond to the DIS. If two-thirds of
the TC and SC members
approve of the DIS, and if three-quarters of the member bodies of ISO approve of
the DIS, the draft is
revised and moves into the Approval Stage. If the voting requirements are not
met, the draft is returned to
the Committee Stage for further revision.
• Stage 5: Approval
– The final version of the DIS is submitted for a second vote among the member
bodies of ISO. Member
bodies have two months to place their votes. The draft is approved if two-thirds of
the TC and SC members
and three-quarters of the member bodies of the ISO vote in favor of the DIS. Any
technical comments
received at this stage are saved for later review.
• Stage 6: Publication
– Minor editorial changes are made to the final International Standard, which is
then published by ISO.
Within three years, the new standard is reviewed by the TC/SC and member
bodies of the organization and
revised if necessary.

 3. Introduction to ISO 9000 •

The ISO 9000 family of standards is related to quality management systems and designed to help
organizations ensure that they meet the needs of customers and other stakeholders while meeting
statutory and regulatory requirements.
• ISO 9000 deals with the fundamentals of quality management systems, including the eight
management principles on which the family of standards is based. International standards
promote international trade by providing one consistent set of requirements recognized around
the world.
• ISO 9000 can help a company satisfy its customers, meet regulatory requirements and achieve
continual improvement. It provides the base level of a quality system, not a complete guarantee
of quality.
• Originally published in 1987 by the International Organization for Standardization (ISO), a
specialized international agency for standardization composed of the national standards bodies of
90 countries.
Eight Quality Management Principles:
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decisionmaking
8. Mutually beneficial supplier relationships

ISO 9000 Series


ISO 9000
• Explains fundamental quality concepts and provides guidelines for the selection and application
of each standard
ISO 9001 • Model for quality assurance in design, development, production, installation and
servicing.
ISO 9002 • Model for quality assurance in the production and installation of manufacturing
systems
ISO 9003 • Quality assurance in final inspection and testing.
ISO 9004 • Guidelines for the applications of standards in quality management and quality
systems.

ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to accomplish
the requirements outlined in standards 9001, 9002 or 9003.

Advantages
 Quality is maintained,
 ISO registration also has a significant bearing on market credibility as well.
 Opportunity to compete with larger companies,
 More time spent on customer focus,
 Confirmation that your company is committed to quality,
 May facilitate trade and increased market opportunities,
 Can increase customer confidence and satisfaction.
Clauses
The requirements of the standard are specified in following clauses of the standard:
Clause 4 • Quality Management System
Clause 5 • Management responsibility
Clause 6 • Resource management
Clause 7 • Product realization
Clause 8 • Measurement, analysis and improvement

Quality Management Clause


General requirements
Documentation requirement
Quality manual
Control of records and documents
Management responsibility clause
Customer focus
Quality objective
Quality policy
Quality management system
planning
Management representative
Internal communication
Resource management requirement clause ▫

Competence, awareness and training ▫

Infrastructure ▫

Work environment •

Product realization requirement clause ▫

Planning of product realization

▫ Customer related process

▫ Customer communication

• Measurement, analysis and improvement clause

▫ General requirements
▫ Monitoring and measurement

 customer satisfaction

 Internal audit

▫ Analysis of data

▫ Continual improvement

ISO 9001
ISO 9001 is the standard that gives the
requirements for a quality management
system
 ISO 9001:2008 is the latest, improved version
 It is the only standard in the ISO 9000 family
that can be used for certification
 There are 16 other standards in the family
that can help an organization on specific
aspects such as performance improvement,
auditing, training

 ISO 9000-1 is a general guideline which gives background


information about the family of standards
 ISO 9001, ISO 9002, and ISO 9003 are standards in the
family, containing requirements on a supplier
 ISO 9002 and ISO 9003 are subsets of ISO 9001
◦ ISO 9002 applies when there is no design
◦ ISO 9003 applies when there is neither design nor production
 ISO 9004 is a comprehensive guideline to the use of the ISO
9000 standards
 For software development, ISO 9001 is the standard to use
 ISO 9000-3 is a guideline on how to use ISO 9001 for
software development
 ISO 9004-2 is a guideline for the application of ISO 9001 to
the supply of services (including computer centers and other
suppliers of data services)

• As opposed to ISO 9000 which was introduced in 1987, ISO


9001,ISO 9002, and ISO 9003 were all combined in year 2000
and called ISO 9001:2000.
• ISO 9001 was updated in 2008 and is known as ISO 9001:2008.
The changes are considered minor. Companies that seek ISO
9001:2008 certification will be evaluated by the process of
examining a sample of their product(s) , processes and functions
to see if they are compliant
FACTS ABOUT ISO 9001

ISO 9001 and ISO 14001 are among ISO's


most well known standards ever.
 They are implemented by more than a
million organizations in some 175
countries.
 ISO 9001 helps organizations to implement
quality management

The rules are updated as the requirements change over the time. Some of the
requirements in ISO 9001:2008 include

a set of procedures that cover all key


processes in the business
 monitoring processes to ensure they are
effective
 keeping adequate records
 checking output for defects, with appropriate
and corrective action where necessary
 regularly reviewing individual processes and
the quality system itself for effectiveness
 facilitating continual improvement