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QUALITY MANAGEMENT

LGB 20503

..\..\Course Outline\LGB 20503-Quality Lecturer:


Management Course Outline SLT.doc Fauzuddin Ayob
B. Eng Marine Eng;
M. Eng Materials Sc & Eng
..\..\Lesson Plan\LGB 20503 Quality
Management.doc
SECTION 6 – ISO 9000

Sub-Topics:
 Lesson Plan 1: Introduction to ISO and ISO
9000 family
 Lesson Plan 2: Discuss and outline the ISO
9000 seven quality management principles
 Lesson Plan 3: Introduction to ISO
9001:2015 quality management system
 Lesson Plan 4: Briefly discuss the ISO
9001:2015 clauses and requirements
International Standards

• ISO Standards
• ISO Quality Standards
Who ISO is

• ISO ( International Organization for


Standardization) is the world’s largest
developer of standards
• ISO is a network of the national standards
institutes of 156 countries, on the basis of
one member per country, with a Central
Secretariat in Geneva, Switzerland, that
coordinates the system
ISO Organization

General
Assembly

Policy
Technical
Development Council
Management Board
Committees

Technical Advisory
Groups

Technical Committees
Technical Committees
Technical Committees
Technical Committees
Who ISO is and
how it all started
• ISO is a non-governmental
organization
• Used derived from Greek
words isos meaning “equal”
• International standardization
began in the electrotechnical
field : the International
Electrotechnical Commission
(IEC) was established in
1906
How it all started

• Pioneering work in other fields was carried


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
came to an end in 1942
How it all started

• In 1946, delegates from 25 countries met


in London and decided to create a new
international organization, of which the
object would be “to facilitate the
international coordination and unification
of industrial standards”
• The new organization, ISO, officially
began operations on 23 February 1947
ISO INTERNATIONAL STANDARD

The aim is to facilitate trade, exchange and technology


transfer through :

• 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.
What ‘international
standardization’ means

• When the large majority of products or


particular business or industry sector conform
to International Standards, a state of industry-
wide standardization can be said to exist
• This is achieved through consensus
agreements between national delegations
representing all the economic stakeholders
concerned – suppliers, users, government
regulators and other interest groups, such as
consumers
What ‘international
standardization’ means
• They agree on specifications and criteria to be
applied consistently in the classification of
materials, in the manufacture and supply of
products, in testing and analysis, in
terminology and in the provision of services.
• In this way, International Standards provide a
reference framework, or a common
technological language, between suppliers and
their customers – which facilitates trade and
transfer of technology
The big, wide world of ISO
standards

• Between 1947 and the present day, ISO


published more than 20,000 International
Standards. ISO's work programme ranges
from standards for traditional activities, such
as agriculture and construction, through
mechanical engineering, to medical devices,
to the newest information technology
developments, such as the digital coding of
audio-visual signals for multimedia
applications.
What makes ISO 9000 and
ISO 14000 so special
• More than a million organizations in more 150
countries are implementing ISO 9000 which
provides a framework for quality management
throughout the processes of producing and
delivering products and services for the customer.
• The ISO 9000 and ISO 14000 families are among
ISO’s most widely known standard ever
• ISO 9000 has become an international reference for
quality requirements in business to business
dealings, and ISO 14000 looks set to achieve at
least as much, if not more , in helping organizations
to meet their environmental challenges
ISO 14000

• ISO 14000 is primarily concerned with


“environmental management”

• This means what the organization does to


minimize harmful effects on the
environment caused by its activities, and
continually to improve its environmental
performance
ISO 9000

• ISO 9000 is concerned with “quality


management”

• This means what the organization does to


enhance customer satisfaction by meeting
customer and applicable regulatory
requirements and continually to improve
its performance in this regard.
WHERE DOES ISO 9000
COME FROM ?

• Coordinated by International Organization for


Standardization (ISO)
• Over 70 Countries participate in writing the
Standard
• Internationally accepted
– Approximately >150 Countries have adopted as their
QMS Standard
– Adopted as a European Standard
– Adopted as a British Standard
– >1,00,000 Users World wide
Who created the
standards?
• International Organization for
Standardization - Geneva
• ISO tech committee - TC 176 started in
1979
• Standards created in 1987
– To eliminate country to country differences
– To eliminate terminology confusion
– To increase quality awareness
ISO 9000
Why is ISO 9000
important?

• European Union directive


– ISO 9000 certification required by suppliers
of “Regulated Products”
• health, safety, and the environment
– EC has strict corporate liability legislation
protecting consumers
• Globalization impact
Why adopt ISO 9000?

• To comply with customers who require


ISO 9000
• To sell in the European Union market
• To compete in domestic markets
• To improve the quality system
• To minimize repetitive auditing by similar
and different customers
• To improve subcontractors’ performance
WHAT IS ISO 9000
ABOUT ?

• International consensus on good


management practice
• Looks for repeatability and meeting
customer requirements
• Distilled into standard requirements
• Covers any organization – whatever the
size, industry or culture
ISO Quality Standards

• ISO 9000 family


1. ISO 9000 -2015 – Quality Management
Systems – Fundamentals and Vocabulary
2. ISO 9001 – 2015 – Quality Management
Systems - Requirements
3. ISO 9004 – 2009 – Quality Management
Systems – Guidelines for performance
improvements
4. ISO 19011 – 2011 – Guidelines for Auditing
Quality Management Systems and/or
Environmental Management Systems
Description of quality
standards
• ISO 9000 - Describes the fundamental
aspects of quality management and the
various terms used
• ISO 9001 – Specifies the requirement for the
quality management system. It is used to
determine whether an organization can meet
the requirements of its customers. The same
standards can be used to verify whether an
organization’s quality system can meet the
requirements of a regulatory body.
Description of quality
standards

• ISO 9004 – Specifies the requirements for


upgrading an organization's quality control
capability. It is more comprehensive than
9001. It is no needed for certification
purposes or contract purposes.
• ISO 19011 – Provides guidelines on the
principles of auditing. (Applies to quality
system and environment systems)
Benefits of Registration

• Improved operations
• Improved operating margin
• External recognition
• Market expansion
DEVELOPMENT OF QUALITY
SYSTEM STANDARDS
1975 - QA-42 DEVELOPED BY CEGB, UK.

1979 - BRITISH STANDARD 5750 ON QUALITY SYSTEMS.

1981 - BS:5750 ON QUALITY SYSTEMS –REVISED.

1987 - ISO-9000 SERIES WAS ISSUED FIRST TIME.

1994 - REVISED ISO-9000 SERIES ISSUED.

2000 - REVISED ISO-9000 SERIES ISSUED.

2008 - REVISED ISO-9000 SERIES ISSUED.

2015 - CURRENT SERIES OF ISO-9000 ISSUED.


QUESTION & ANSWER

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