STATISTICAL QUALITY

IMPROVEMENT
(SQQS 3063

Quality Management System

(QMS):

International Organization for

Standardization (ISO)

Quality Management System

(QMS)
QMS is a system that outlines the policies
and procedures necessary to improve and
control the various processes that will
ultimately lead to improved business
performance.
ISO 9000 standards have been adopted
worldwide as the mainframe of QMS and have
undergone significant development over the
years.

SQQS3063- Chapter 1

The 8 QMS Principles

1. Customer focus
Organization depends on their customers
and therefore should understand current
and future customer needs, should meet
customer requirements and strive to exceed
customer expectations.

2. Leadership

Leaders establish unity of purpose and

direction of the organization. They should
create and maintain the internal
environment in which people can become
fully involved in achieving the organizations
objectives.
SQQS3063- Chapter 1
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The 8 QMS Principles

3. Involvement of people
People at all levels are the essence of
an organization and their full
involvement enables their abilities to
be used for the organizations benefit

4. Process approach

A desired result is achieved more

efficiently when related resources and
activities are managed as a process.
SQQS3063- Chapter 1

The 8 QMS Principles

5. System approach to management
Identifying, understanding and managing
interrelated processes as a system
contributes to the organizations
effectiveness and efficiency in achieving its
objectives.

6. Continual improvement

Time

SQQS3063- Chapter 1

Trend

Continual improvement of the organizations

overall performance should be a permanent
objective of the organization.

Trend

The 8 QMS Principles

7. Factual approach to decision making
Effective decisions are based on the logical
analysis of data and information.

8. Mutually beneficial supplier relationship

An organization and its supplier are
interdependent and
a mutually beneficial relationship
enhances the ability of both to create value.

SQQS3063- Chapter 1

What do 8 QMS Principles do?

Provide direct benefits towards
organization purpose and goal
Contribute in managing benefits, costs and
risks.
Impact on organization performance seen
through:
Customer loyalty, increase in market share,
boost confidence, competitive advantage, etc.

SQQS3063- Chapter 1

ISO - why standard is

important?
Standards ensure desirable characteristics of products
and services such as quality, environmental
friendliness, safety, reliability, efficiency - and at an
economical cost.
When products and services meet our expectations, we
tend to forget about standard. However, when
standards are absent, we soon notice. We soon care
when products turn out to be of poor quality, do not fit,
are incompatible with equipment that we already have,
are unreliable or dangerous.
When products, systems, machinery and devices work
well and safely, it is often because they meet standards

What standards do?

make the development, manufacturing and supply of
products and services more efficient, safer and cleaner
facilitate trade between countries and make it fairer
provide governments with a technical base for health,
safety and environmental legislation, and conformity
assessment
share technological advances and good management
practice
disseminate innovation
safeguard consumers, and users in general, of products
and services
make life simpler by providing solutions to common
problems
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ISO IN GENERAL.
Aim is to help organizations be more
effective
and efficient
Effective = Achieving the planned
results
Efficient = Optimizing use of
resources
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Who will benefit?

For businesses, the widespread adoption of International
Standards means that suppliers can develop and offer products
and services meeting specifications that have wide
international acceptance in their sectors. Therefore,
businesses using International Standards can compete on many
more markets around the world.
For innovators of new technologies, International Standards on
aspects like terminology, compatibility and safety speed up
the dissemination of innovations and their development
into manufacturable and marketable products.
For customers, the worldwide compatibility of technology
which is achieved when products and services are based on
International Standards gives them a broad choice of offers.
They also benefit from the effects of competition among
suppliers.
For governments, International Standards provide the
technological and scientific bases, underpinning health,
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safety and environmental legislation.

 For trade officials, International Standards create "a level playing

field" for all competitors on those markets. The existence of divergent
national or regional standards can create technical barriers to trade.
International Standards are the technical means by which political
trade agreements can be put into practice.
For developing countries, International Standards that represent an
international consensus on the state of the art are an important source
of technological know-how. By defining the characteristics that
products and services will be expected to meet on export markets,
International Standards give developing countries a basis for making
the right decisions when investing their scarce resources and thus
avoid wasting them.
For consumers, conformity of products and services to International
Standards provides assurance about their quality, safety and
reliability.
For everyone, International Standards contribute to the quality of life
in general by ensuring that the transport, machinery and tools we use
are safe.
For the planet we inhabit, International Standards on air, water and
soil quality, on emissions of gases and radiation and environmental
aspects of products can contribute to efforts to preserve the
environment.

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Non Governmental
Organization
ISO standards are technical agreements
which provide the framework for compatible
technology worldwide. They are designed to
be globally relevant - useful everywhere in the
world.
ISO standards are useful everywhere in
the world.
ISO standards are voluntary. As a nongovernmental organization, ISO has no legal
authority to enforce the implementation of its
standards.
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Scope of ISO work

ISO's work programme ranges from
standards for traditional activities,
such as agriculture and construction,
through mechanical engineering,
manufacturing and distribution, to
transport, medical devices,
information and communication
technologies, and to standards for
good management practice and for
services.

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Examples of the benefits standards provide

solves the repair and maintenance problems caused by a lack of

standardization that were once a major headache for manufacturers
and product users.
Without the standardized dimensions of freight containers,
international trade would be slower and more expensive.
Consensus on grades of various materials gives a common reference
for suppliers and clients in business dealings.
Without the international agreement contained in ISO standards on
metric quantities and units, shopping and trade would be
haphazard, science would be unscientific and technological
development would be handicapped.
Agreement on test methods allows meaningful comparisons of
products, or plays an important part in controlling pollution - whether
by noise, vibration or emissions.
Safety standards for machinery protect people at work, at play, at
sea... and at the dentist's.
Standardized documents speed up the transit of goods, or identify
sensitive or dangerous cargoes that may be handled by people
speaking different languages.

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ISO.
guides and standards for conformity assessment
represent an international consensus on best
practice.
Their use contributes to the consistency of conformity
assessment worldwide and so facilitates trade.
"Conformity assessment" means checking that
products, materials, services, systems, processes or
people measure up to the specifications of a
relevant standard or specification.
products require testing for conformity with
specifications or compliance with safety, or other
regulations before they can be put on many markets.

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What "international standardization" means

When the large majority of products or services in a
particular business or industry sector conform to
International Standards, a state of industry-wide
standardization exists.
The economic stakeholders concerned 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.
This facilitates trade and the transfer of technology
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ISO 9000:2000 Family

ISO 9000
Describes fundamentals
Specifies the terminology & definition

ISO 9001
Specifies requirements

ISO 9004

audit or register to ISO 9001 only

Provides guidance to implementation

Processes for continual improvement
Clarifies satisfaction measures

SQQS3063- Chapter 1

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ISO 9001 and ISO 14001

ISO 9001 (quality) and ISO 14001 (environment)

are "generic management system standards.
Generic means that the same standard can be
applied to any organization, large or small,
whatever its product or service, in any sector of
activity, and whether it is a business enterprise, a
public administration, or a government
department.
ISO 9001 contains a generic set of requirements
for implementing a quality management system
and ISO 14001 for an environmental
management system.

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What is ISO 9000?

ISO 9000 is a generic name given to

a family of standards developed to
provide a framework (guidelines)
around which a quality management
system can effectively be
implemented.
represents an international
consensus on good quality
management practices.
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How the model works?

ISO 9000 lays down what
requirements your quality system
must meet, but does not dictate
how they should be met in any
particular organization. This leaves
great scope and flexibility for
implementation in different business
sectors and business cultures, as well
as in different national cultures.
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 2011 survey from the British

Assessment Bureau showing 44% of
their certified clients had won new
business.
Implementing ISO 9000 showed that
certified organizations achieved
superior return on assets
compared to otherwise similar
organizations without certification,
led to superior operational and
financial performance.
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3 Models of ISO 9000:1987 for quality

management systems
ISO 9001:1987 Model for quality assurance in
design, development, production, installation,
and servicing was for companies and organizations
whose activities included the creation of new products.
ISO 9002:1987 Model for quality assurance in
production, installation, and servicing had
basically the same material as ISO 9001 but without
covering the creation of new products.
ISO 9003:1987 Model for quality assurance in
final inspection and test covered only the final
inspection of finished product, with no concern for how
the product was produced.
ISO 9000:1987 was also influenced by existing U.S.
23 to
and other Defense Standards, and so was well-suited

ISO 9000:1994 (1994 version)

Emphasized quality assurance via

preventive actions, instead of just checking
final product, and continued to require evidence
of compliance with documented procedures.
As with the first edition, the down-side was
that companies tended to implement its
requirements by creating shelf-loads of
procedure manuals, and becoming
burdened with an ISO bureaucracy. In some
companies, adapting and improving processes
could actually be hampered by the quality
system.
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ISO 9001:2000
combines the three standards 9001, 9002, and 9003 into one,
called 9001.
Design and development procedures are required only if a
company does in fact engage in the creation of new products.
The 2000 version sought to make a radical change in thinking by
actually placing the concept of process management front and
center ("Process management" was the monitoring and optimizing
of a company's tasks and activities, instead of just inspecting the
final product).
The 2000 version also demands involvement by upper executives,
in order to integrate quality into the business system and avoid
delegation of quality functions to junior administrators. Another
goal is to improve effectiveness via process performance metrics
numerical measurement of the effectiveness of tasks and
activities. Expectations of continual process improvement and
tracking customer satisfaction were made explicit.
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ISO 9001:2008
Certification ISO 9001:2008 only introduces
clarifications to the existing requirements of
ISO 9001:2000 and some changes intended to
improve consistency with ISO 14001:2004
(ISO 14001-Environmental management
standards)
There are no new requirements.
E.g: A quality management system being
upgraded just needs to be checked to see if it
is following the clarifications introduced in the
amended version
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Why an organization should

implement ISO 9000?
Without satisfied customers, an
organization is in peril! To keep
customers satisfied, the organization
needs to meet their requirements.
The ISO 9001:2008 standard provides a
tried and tested framework for taking
a systematic approach to managing
the organization's processes so that they
consistently turn out product that
satisfies customers' expectations.
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 To check that it works:

1)

The standard requires the organization itself to audit

its ISO 9001:2008-based quality system to verify that it is
managing its processes effectively - or, to put it another way,
to check that it is fully in control of its activities .

2) In addition, the organization may invite its clients to

audit the quality system in order to give them confidence
that the organization is capable of delivering products or
services that will meet their requirements.
3) Lastly, the organization may engage the services of an
independent quality system certification body to obtain
an ISO 9001:2008 certificate of conformity. This last option
has proved extremely popular in the market-place because of
the perceived credibility of an independent assessment.
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Advantages of ISO 9000

A proper quality management improves business,
often having a positive effect on investment, market
share, sales growth, sales margins, competitive
advantage, and avoidance of litigation. Some of the
advantages:
Create a more efficient, effective operation
Increase customer satisfaction and retention
Reduce audits
Enhance marketing
Improve employee motivation, awareness, and morale
Promote international trade
Increase profit
Reduce waste and increase productivity.

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Problems with ISO 9000

A common criticism of ISO 9001 is the amount of money, time
and paperwork required for registration.
not in any way an indication that products produced using its
certified systems are any good. A company can intend to
produce a poor quality product and providing it does so
consistently and with the proper documentation can put an ISO
9001 stamp on it.
promotes specification, control, and procedures rather than
understanding and improvement.
effective as a guideline, but that promoting it as a standard
helps to mislead companies into thinking that certification
means better quality.
reliance on the specifications of ISO 9001 does not guarantee a
successful quality system.
Another problem reported is the competition among the
numerous certifying bodies, leading to a softer approach to the
defects noticed in the operation of the Quality System of a firm 30

ISO 9000 vs TQM

ISO-9000 is a set of standards and focuses on
documents. It ignores human element. On the contrary,
TQM features on developing human elements.
It is important to note that TQM and ISO 9000
Standard are not in opposition. One is supporting the
other. The ISO-9000 standard establishes the principles
for a management system which will improve a
companys performance. It provides basic building
block for moving towards TQM. TQM is a much bigger
concept than ISO. It is a way of life or an approach,
which is peculated so that a company is better,
managed.

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ISO 9000
Focus on:
Certification
Product conforms to specification
Audits and check
Key processes
Quality system
External Trust
Visibility of capability prior to delivery
Maintenance of what is documented
An assurance to external customers that a quality
system is being pursued.
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TQM
Focus on:
Customer delight and satisfaction
Total organization including invisible and visible
resources
Total Quality Management
Internal and External Trust
Leadership
Internal Customer
Human Factor
Flexibility and change Management
Top management commitment
Continuous improvement
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 Although Total Quality Management

(TQM) came on the scene first as a
method for companies to improve
profits and repeat business,
complying to the ISO 9000 standards
is the first thing a company should
consider to improve the way it does
business.
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