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ISO 9001: Quality

Management Basics

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Learning Objectives
• QUALITY
• QUALITY CONTROL
• QUALITY ASSURANCE
• QUALITY MANAGEMNT
• TOTAL QUALITY MANAGEMENT
• Little q vs Big Q
• ISO SYSTEM
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QUALITY

A subjective term for which each person

has his or her own definition.
• Characteristics of a product that bears on
it’s ability to satisfy the stated or implied
needs.( ASQ)
(ASQ)
Note:
American Society for Quality ASQ
American Society for Quality Control.(ASQC)
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QUALITY
• Features of products which meet customer
needs and thereby provide customer
satisfaction.

• In this sense the meaning of quality is

oriented to income

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QUALITY
• A product or service free of deficiencies.

Freedom from errors that require doing work

over again (rework) or that may results in field of
failures, customer dissatisfaction, customer
claims and so on.

In this sense quality is oriented to cost and

higher quality means “ Costs Less”
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QUALITY
Product features meet
customer needs
• Higher quality enables
companies to:
• Increase customer satisfaction
• Make products salable
• Meet competition
• Increase market share
• Provide sales income
• Secure premium prices
• The major effect is on
sales
• Usually higher quality
costs more.
Freedom from deficiences
• Freedom from
deficiencies
• Reduce error rates
• Reduce rework, waste
• Reduce failure
• Warranty charges
• Reduce customer dissatisfaction
• Reduce inspection, test
• Shorten time to put new products in the
market
• Increase yields, capicity
• Improve delivery performance
• Major effect is on cost
• Usually, higher quality
costs less
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What is Quality?
• User-based: “In the eyes of the beholder”
• Manufacturing-based: “Right the first
time”
• Product-based: Precise measurement

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Accuracy Vs
Precision
Accuracy
The accuracy of a
measurement describes
how close it is to the
'real' value.

Precision
The ability of a
measurement to be
consistently reproduced

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Dimensions of Product Quality

• Performance
• Aesthetics
• Special features: convenience, high tech
• Safety
• Reliability
• Durability
• Perceived Quality
• Service after sale

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 Dimension 1: Performance
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Does the product or service do what it is

supposed to do, within its defined
tolerances?
• Performance is often a source of
contention(conflict) between customers and
suppliers, particularly when deliverables are not
adequately defined within specifications.
• The performance of a product often influences
profitability or reputation of the end-user. As
such, many contracts or specifications include
damages related to inadequate performance.
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Dimension 2: Features
• Does the product or services possess all of
the features specified, or required for its
intended (future planned) purpose?
While this dimension may seem obvious,
performance specifications rarely define the
features required in a product. Thus, it’s
important that suppliers designing product or
services from performance specifications are
familiar with its intended uses, and maintain
close relationships with the end-users.
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Dimension 3: Reliability

• Will the product consistently perform within

specifications?
• Reliability may be closely related to
performance. For instance, a product
specification may define parameters for up-time,
or acceptable failure rates.
• Reliability is a major contributor to brand or
company image, and is considered a
fundamental dimension of quality by most end-
users.
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Dimension 4: Conformance

• Does the product or service conform to

the specification?
• If it’s developed based on a performance
specification, does it perform as specified?
• If it’s developed based on a design
specification, does it possess all of the
features defined?

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Dimension 5: Durability

• How long will the product perform or last,

and under what conditions?
• Durability is closely related to warranty.
Requirements for product durability are often
included within procurement contracts and
specifications.
• For instance, fighter aircraft procured to operate
from aircraft carriers include design criteria
intended to improve their durability in the
demanding naval environment.
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Dimension 6: Serviceability

• Is the product relatively easy to

maintain and repair?
• As end users become more focused on
Total Cost of Ownership than simple
procurement costs, serviceability (as well
as reliability) is becoming an increasingly
important dimension of quality and criteria
for product selection.

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Dimension 7: Aesthetics

• The way a product looks is important to

end-users. The aesthetic properties of a
product contribute to a company’s or
brand’s identity. Faults or defects in a
product that diminish its aesthetic
properties, even those that do not reduce
or alter other dimensions of quality, are
often cause for rejection.

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Dimension 8: Perception
• Perception is reality. The product or service
may possess adequate or even superior
dimensions of quality, but still fall victim to
negative customer or public perceptions.
• As an example, a high quality product may get
the reputation for being low quality based on
poor service by installation or field technicians. If
the product is not installed or maintained
properly, and fails as a result, the failure is often
associated with the product’s quality rather than
the quality of the service it receives.
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Dimensions of service Quality

1. Time & Timeliness
–customer waiting time, completed on
time
2. Completeness
–customer gets all they asked for
3. Courtesy
–treatment by employees

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Dimensions of service Quality

4. Consistency
–same level of service for all customers
5. Accessibility & Convenience
–ease of obtaining service
6. Accuracy
–performed right every time
7. Responsiveness
–reactions to unusual situations
--reaction time of the service.
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Two Aspects of Quality

Quality of design measures how closely

the characteristics of products or services
meet the needs and wants of customers.
Conformance quality refers to the
performance of a product or service
according to design and product
specifications.

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GRADE ?
Category or rank given to different quality
requirements for products, processes, or
systems having the same functional use
( ISO 9001:2000)

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Importance of Quality
• Lower costs (less labor, rework, scrap)
• Motivated employees
• Market Share
• Reputation
• International competitiveness
• Revenues generation increased (ultimate
goal)

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INSPECTION

• It is the sorting / segregation of Non

conforming items from the conforming
items
• Means separation of Defective items from
the right items

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QUALITY CONTROL

Quality control: The observation,

technical techniques and activities that
are used to fulfill requirements for quality.
OR
• Quality Control (QC) is a system of routine
technical activities, to measure and control
the quality of the inventory as it is being
developed.
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QUALITY CONTROL
The QC system is designed to:

(i) Provide routine and consistent checks to ensure

data integrity, correctness, and completeness;
(ii) Identify and address errors and omissions;
(iii) Document and archive inventory material and
record all QC activities.

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QUALITY ASSURANCE
is all systematic and planned actions
which are necessary to provide
adequate confidence that a product or
service will satisfy the given
requirement for quality.

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QUALITY MANAGEMENT
is a systematic set of operating
procedures which is company wide,
documented, implemented and
maintained while ensuring the growth
of business in a consistent manner

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QM Vs QA
The Prime Focus of

Quality Management Quality Assurance

Achieving results that satisfy the Demonstrating that the requirements for
requirements for quality. quality have been (and can be) achieved.

Motivated by stakeholders internal to the Motivated by stakeholders, especially

organization, especially the organization’s customers, external to the organization
management

Goal is to satisfy all stakeholders Goal is to satisfy all customers.

Effective, efficient, and continually Confidence in the organization’s products

improving, overall quality-related is the intended result
performance is the intended result.

Scope covers all activities that affect the Scope of demonstration coves activities
total quality-related business results of the that directly affect quality-related process
organization and product results
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TOTAL QUALITY MANAGEMENT

► THE LATEST APPROACH
► The comprehensive approach towards
quality management system
► It is the process of individual &
organizational development the purpose of
which is to increase the level of satisfaction
of all the stakeholders

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HIERARCHIAL STRUCTURE
► TOTAL QUALITY MANAGEMENT

QUALITY MANAGEMENT

QUALITY ASSURANCE

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HIERARCHIAL STRUCTURE
► QUALITY ASSUR. (GMP+Original prod. design &
development)

GOOD MFG. PRACTICE

QUALITY CONTROL
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HISTORICAL BACKGROUND
► THE OLDEST TERM QUALITY

► QUALITY CONTROL

► QUALITY ASSURANCE (1970s)

► QUALITY MANAGEMENT

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HISTORICAL BACKGROUND

► TOTAL QUALITY MANAGEMENT

CURRENTLY ENTERPRISES ARE RUSHING TO

1. SIX SIGMA
2. DEMING AWARD
3. MALCOLM BALDRIDGE NATIONAL QUALITY
AWARD (MBNQA)

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Quality Statements
► There are three types of quality statements:
1. Vision statement
2. Mission statement
3. Quality policy statement

The utilization of these statements varies from

organization to organization. Small organization
may use only the quality policy statement

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Vision Statement
A vision statement is sometimes called a picture
of your company in the future but it’s so much
more than that. Your vision statement is your
inspiration, the framework for all your strategic
planning.
A vision statement may apply to an entire
company or to a single division of that company.
Whether for all or part of an organization, the
vision statement answers the question, “Where do
we want to go?”
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Example
► Institute of Quality & Technology
Management (IQTM) will be a dynamic
contributor of the professionals to the local,
regional, national, and international
manufacturing and services organizations in
the field of Industrial Engineering & Quality
Management.

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Mission Statement
► A mission statement concerns what an organization is all
about. The statement answers the questions such as: who
we are, who are our customers, what do we do and how
do we do it. This statement is usually one paragraph or
less in length, easy to understand, and describes the
function of the organization. It provides clear statement of
purpose for employees, customers, and suppliers.

Mission statements describe the overall purpose of

an organization: what you do, who you do it for,
and how and why you do
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Example
► The IQTM has 3 fold educational missions:
1. The teaching mission is to provide high quality
undergraduate and postgraduate courses in the field
of Industrial Engineering and quality management.
2. The research mission is to advance knowledge in the
area of Industrial Engineering & Quality Management
to strengthen and support manufacturing and service
sectors
3.
The service mission is to participate in the faculty
governance, in the broader community of the
engineering profession, and in the mission of the
university. 50
 Difference between a mission
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statement and a vision statement

a mission statement focuses on a

company’s present state
while
a vision statement focuses on a
company’s future.
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Quality Policy Statement

► The quality policy is a guide for everyone in
the organization as to how they should
provide products and services to the
customers. It should be written by the CEO
with feedback from the workforce and be
approved by the quality council. A quality
policy is a requirement of ISO 9000.

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QUALITY POLICY
► It is the mission statement of the
organization which is consistent with other
organizational policies, and is understood,
implemented, and reviewed at all level of
the organizations.

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Quality Policy Example

► Institute of Quality and Technology Management,
University of the Punjab is committed to provide efficient
and cost effective education/training in Quality
Management for Manufacturing and Service sectors. We
are dedicated to provide trained professionals who shall be
instrumental in our continuous quality improvement in
manufacturing and services sectors of Pakistan. We shall
achieve our aims by fulfilling our objectives, training of our
faculty members and assuring a continual quality
improvement in our working system.

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QUALITY OBJECTIVES
► Quality Objectives are measurable goals
pertaining to quality, fitness for use,
performance, safety, and dependability
which is consistent with the quality policy
and which reflect the satisfaction of
customers requirements.

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QUALITY MANUAL
► The main document used to demonstrate or
describe a documented quality system.
► A sign-post or map of a quality system.

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QUALITY PROCEDURES
► Quality Procedures are elements,
requirements and descriptions of process
adopted by an Organization for its quality
system, which are documented in an orderly
and understandable manner.

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QUALITY RECORDS
► Quality Records – All evidence in any
form (whether on paper, magnetic disks,
software or other form of recordings) which
demonstrate conformance to specified
requirements, and the effective operation of
the quality system.

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QUALITY COSTS
► Quality Costs – All corrective, preventive,
inspecting, and opportunities lost as a result
of not meeting customer requirements.

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“BIG Q” Vs “LITTLE q”

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“BIG Q” Vs “LITTLE q”

Expression that contrasts the difference

between striving for quality in all of the
firm's products and processes (the big 'Q')
and striving for quality in a limited or
specific area (the little 'q').

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GLP -----Goods laboratory practices

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TQM Vs ISO SYSTEM (1)

ISO 9000 TQM
NOT NECESSARILY DEFINITELY
CUSTOMER CUSTOMER FOCUSED
FOCUSED
TECHNICAL SYSTEM PHILOSPHY,
& PROCEDURES CONCEPTS, TOOLS
FOCUSED &TECHNIQUES
FOCUSED
EMPLOYEE EMPLOYEE
INVOLVEMENT NOT INVOLVEMENT
NECESSARY NECESSARY 64
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TQM Vs ISO SYSTEM (2)

ISO 9000 TQM
LESS OR NO FOCUS CQI &TQM ARE
ON CQI (Continuous SYNONYM
Quality Improvement)
CAN BE ORGANIZATION WIDE
DEPATMENTALLY
FOCUSED
QUALITY EVERYONE
DEPARTMENT RESPONSIBLE FOR
RESPONSIBLE FOR QUALITY
QUALITY 65