QUALITY MANAGEMENT

SYSTEM

Dr. Muhammad Shafiq

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 Meaning of Quality?

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Meaning of Quality

3-3
Meaning of Quality
 Webster’s Dictionary
 degree of excellence of a thing

 American Society for Quality

 totality of features and characteristics that satisfy needs

 Fitness for purpose or use (Juran)

 Quality is conformance to the requirements (Crosby)

 Quality should be aimed at the needs of the consumer,

present and future (Deming)

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 Who defines quality?
So, which person, or group of people defines
whether an organisation delivers quality, or not?

5
 KANO MODEL
“When you meet customer requirements,
you do not gain customer loyalty. You need
to WOW them to have customers for life.”
The Kano Model is a pictorial way to look at
customer levels of dissatisfaction and
satisfaction to define how they relate to the
different product characteristics.

Professor Noriako Kano developed the Kano

Model in the 1980s.
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2/20/2019 7
How to Use Kano Model
• Threshold (Basic or Must-be) Attributes:
• these are the attributes that the customer must have.
• They do not provide an opportunity for product differentiation.

• Performance (One-Dimensional) Attributes:

• these are attributes that will increase customer satisfaction.
• The better or more of these attributes you are offering increases
your chances of higher levels of customer satisfaction.

• Excitement (Attractive) Attributes:

• these are attributes that will WOW the customer.
• They are the ones that are unspoken.
• They are unexpected by the customer but will result in high levels
of customer satisfaction when they are provided.
• The absence of these attributes does not lead to customer
dissatisfaction.
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Analysis for Kano Model
Prioritize needs qualitatively as needs, wants, and wishes.
• Needs must be satisfied
• Wants should be satisfied,
• Wishes can be satisfied.

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 DIMENSIONS OF QUALITY

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 Dimensions of Quality
Manufactured Products
Performance
 basic operating characteristics of a product; how well a
car is handled or its gas mileage
Features
 “extra” items added to basic features, such as a stereo
CD or a leather interior in a car
Reliability
 probability that a product will operate properly within
an expected time frame; that is, a TV will work without
repair for about seven years

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 Dimensions of Quality
Manufactured Products (cont.)

 Conformance
 degree to which a product meets pre–established
standards
 Durability
 how long product lasts before replacement
 Serviceability
 ease of getting repairs, speed of repairs, courtesy and
competence of repair person

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 Dimensions of Quality
Manufactured Products (cont.)

Aesthetics
 how a product looks, feels, sounds, smells, or
tastes
Safety
 assurance that customer will not suffer injury
or harm from a product; an especially important
consideration for automobiles
Perceptions
 subjective perceptions based on brand name,
advertising, and the like

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 Dimensions of Quality
Service
Time and Timeliness
 How long must a customer wait for service, and is it
completed on time?
 Is an overnight package delivered overnight?
Completeness:
 Is everything customer asked for provided?
 Is a mail order from a catalogue company complete when
delivered?

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 Dimensions of Quality
Service
Courtesy:
 How are customers treated by employees?
 Are catalogue phone operators nice and are their voices
pleasant?
Consistency
 Is the same level of service provided to each customer
each time?
 Is your newspaper delivered on time every morning?

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 Dimensions of Quality
Service
 Accessibility and convenience
 How easy is it to obtain service?
 Does a service representative answer you calls quickly?
 Accuracy
 Is the service performed right every time?
 Is your bank or credit card statement correct every month?
 Responsiveness
 How well does the company react to various situations?
 How well is a telephone operator able to respond to a customer’s
questions?

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 •Leading authors have recognized the
inextricable synergy between
organizational excellence and quality

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Evolution of Quality Field
Performance Excellence
Strategic

Six Sigma/BPR/Lean Management Quality

Planning
Process Performance
TQM Knowledge Mgt.

HRM Statistic Business

QA/QM Group Resource
Results

BS 5750 Dynamics Optimization

Teams
QC SPC ISO 9000 IT
Efficiency
Project Mgt.
Quality BPR
Inspection/ Circles
Testing/ TPM
Metrology
JIT/MRP

Product Process System Culture

Improvement Excellence
Inspection Control Approach Change
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Antecedents of Modern Quality Management

Guilds of Medieval Europe

(From the end of 13th Century to Early 19th Century)

The Industrial Revolution

(From the end of 17th Century to 1800s)
The World War II
(From 1938 to 1945)
Post World War Era
(After 1945)
Antecedents of Modern Quality Management (Contd.)
Guilds of Medieval Europe
(From the end of 13th Century to Early 19th Century)
• From the end of the 13th century to the early 19th century, craftsmen across
medieval Europe were organized into unions called guilds.
• These guilds were responsible for developing strict rules for product and
service quality.
• Inspection committees enforced the rules by marking flawless goods with a
special mark or symbol.
• Inspection marks and master-craftsmen marks served as proof of quality for
customers throughout medieval Europe.
• This approach to manufacturing quality was dominant until the Industrial
Revolution in the early 19th century.
Antecedents of Modern Quality Management
(Contd.)

The Industrial Revolution

(From the end of 17th Century to 1800s)

 Craftsmanship

 The Factory System

 The Taylor System

Antecedents of Modern Quality
Management (Contd.)
World War II
 Antecedents of Modern Quality Management
(Contd.)
Post World War II
The Birth of Total Quality Management

• The birth of TQM in US was in direct response to a quality revolution in Japan

following WW-II as Japanese manufacturers converted from Producing Military
Goods for internal use to producing civilian goods for trade.

• At first Japan had a widely held reputation for shoddy exports, and their goods
were shunned by international markets.

• This led Japanese organizations to explore new ways of thinking about quality.
 “If Japan Can… Why Can’t We?”

• By the end of the 1970s, the American quality crisis reached

major proportions, attracting attention from national legislators,
administrators and the media.
• A 1980 NBC-TV News special report, “If Japan Can… Why Can’t
We?” highlighted how Japan had captured the world auto and
electronics markets. Finally, U.S. organizations began to listen.
 The American Response
The US Business Community Wakes up in 1980s from Deep Slumber

 The chief executive officers of major U.S. corporations

stepped forward to provide personal leadership in the
quality movement.

 The U.S. response, emphasizing not only statistics but

approaches that embraced the entire organization, became
known as Total Quality Management (TQM).

 Several other quality initiatives followed. The ISO 9000

series of quality-management standards, for example, were
published in 1987.
 The American Response
The US Business Community Wakes up in 1980s from Deep Slumber

• The Baldrige National Quality Program and Malcolm Baldrige National Quality Award
were established by the U.S. Congress the same year. American companies were at first
slow to adopt the standards but eventually came on board.

 The major rationale behind establishment of this law was intense foreign competition
especially from Japan.

 The award has set a national standard for quality, and hundreds of major corporations
used the criteria in application form as a basic management guide for quality
improvement programs.
 ISO 9001:2015
QUALITY MANAGEMENT
SYSTEM
1
BACKGROUND
 What is ISO?
• International Organization for Standardization
• ISO is derived from the Greek isos, meaning equal.
• The ISO story began in 1946 when delegates from 25 countries met at the Institute of
Civil Engineers in London and decided to create a new international organization ‘to
facilitate the international coordination and unification of industrial standards’.
• On 23 February 1947 the new organization, ISO, officially began operations.
• In 2017, 163 countries were part of ISO’s worldwide membership: 120 countries were full
members, 40 countries were correspondent members and 3 countries were subscriber
members
• ISO has published 22358 International Standards and related documents, covering
almost every industry, from technology, to food safety, to agriculture and healthcare.
• Technical Committees are formed to produce standards. 786 technical committees and
subcommittees to take care of standards development.
• TC 176 for ISO 9000
• International Organization for Standardization
Email: central@iso.ch
Web: http://www.iso.ch
http://www.bsi.org.uk/iso-tc176-sc2.
• First Pakistani company certified in 1994
• More than 220 Certification (Auditing) Agencies throughout the world of which around 15
have offices in Pakistan
What is ISO? (Contd.)

• SO does not perform certification. Organizations looking to get

certified to an ISO standard must contact an independent
certification body. The ISO Survey counts the number of certificates
issued by certification bodies that have been accredited by members
of the International Accreditation Forum (IAF).
What are standards?

• International Standards make things work.

• They give world-class specifications for products, services and
systems, to ensure quality, safety and efficiency.
• They are instrumental in facilitating international trade.
 Some Popular Standards

• ISO 21001 Educational Organization Management System

• ISO 14001 Environmental management
• ISO 26000 Social responsibility
• ISO 31000 Risk management
• ISO 50001 Energy management
• ISO 45001 Occupational health and safety
• ISO 13485 Medical devices
• ISO 37001 Anti-bribery management systems
 What is ISO 9000?

ISO 9000

The word “iso” or

International Organization for The series allocated for
Standardization Quality System standards

• “ISO 9000” is a series of

standards describing the
requirements for
establishing and
maintaining a quality
management system in an
organization
Origin of ISO 9000

ISO 9000:87
ISO 9000:94
ISO 9001:2000
ISO 9001:2008
ISO 9001:2015
BS5750
1979

AQAP1
(NATO)
1970’s
MIL-STD-9858
(1940’s)
Application of ISO 9000

• ISO 9000 is applicable to any type and any size of

organization
• It is not an industry specific or product specific standard
• ISO 9000 involves third party certification
• an independent auditing agency audits the organization against the
requirements of the standard and issues certificate on successful
compliance
• ISO 9000 Certification is valid for three years
• initial certification audit
• yearly or half-yearly surveillance audits
ISO-9001:2015
Where we have been and where we are going
 ISO 9000:2000 Family of Standards
• CORE STANDARDS
• ISO 9000:2000 Fundamentals and Vocabulary
• ISO 9001:2008 QMS Requirements
• ISO 9004:2000 Guidelines for Performance Improvement
• SUPPORTING STANDARDS
• ISO 10005:1995 Guidelines for Quality Plans
• ISO 10006:2003 Guidelines for Project Management
• ISO 10007:2003 Guidelines for Configuration Mgt
• ISO 10012 Measurement Management System
• ISO 10013:2001 Documentation
• ISO/TR 10014:1999 Economics Of Quality
• ISO/TR 10015:2000 Training
• ISO/TR 10017:2003 Statistics
• ISO 19011:2003 Auditing
• ISO 10002:2004 Complaint handling
• ISO 10001 Market based Code of Conduct
• ISO 10003 External Dispute Resolution System
ISO 9000 family

• ISO 9000:2015
• Quality management systems Fundamentals and vocabulary
• ISO 9001:2015
• Quality management systems Requirements
• ISO 9004:2018
• Quality management Quality of an organization Guidance to achieve
sustained success
• ISO 19011:2018
• Guidelines for auditing management systems
• Say what you will do -
• Do what you said -
• Recognize any differences in what you planned and what you
did -
• Act on those differences -
• Ensure action was effective -
• Prove it with documentation.
Process Approach –
Continual Improvements of All Processes

Understanding &
Meeting the Requirements
PLAN

Continual Improvements
Processes in terms
of Processes Based on
Of Added Value PDCA Cycle
Objective Measurements
DO
ACTION

Measure Results of Process

Performance and Effectiveness
- Objective Measurements
CHECK
 Schematic Representation of the Elements of
a Single Process
Starting
End Point
Point

Sources of Inputs Inputs Activities Receivers of outputs

Outputs
Predecessor Matter, SUBSEQUENT
Processes e.g. at energy, Matter, Processes e.g. at
Providers information energy, Customers
(Internal or e.g. In the information (Internal or
External) at form of e.g. In the External) at
customers. At materials, form of other relevant
other relevant resources, product, Interested
Interested requirement service, Parties
Parties s decision

Possible controls and check

points to monitor and
measure performance
 ISO 9001:2008 – Process Model
Continual Improvement of
the Quality Management System

5.Management
Responsibility
CUSTOMER’S

CUSTOMER
Satisfaction
8. Measurement
6. Resource
Analysis and
Management
Improvements

7. Product
Requirements Product Consumption
Realization
 What is ISO 9001?
ISO 9001 is a standard that sets out the requirements for a
quality management system. It helps businesses and
organizations to be more efficient and improve customer
satisfaction.

A new version of the standard, ISO 9001:2015, has just been launched,
replacing the previous version (ISO 9001:2008).
What is a quality management system?

• A quality management system is a way of defining how an organization

can meet the requirements of its customers and other stakeholders
affected by its work.

• ISO 9001 is based on the idea of continual improvement.

• It doesn’t specify what the objectives relating to “quality” or “meeting

customer needs” should be, but requires organizations to define these
objectives themselves and continually improve their processes in order to
reach them.
Who is ISO 9001 for?

• ISO 9001 is suitable for organizations of all types, sizes and

sectors.

• In fact, one of the key improvements of the newly revised ISO

9001:2015 was to make it more applicable and accessible to all
types of enterprises.

• Smaller companies that do not have staff dedicated to quality can

still enjoy the benefits of implementing the standard – ISO has many
resources to assist them.
 What benefits will it bring to my
business or organization?
Implementing a quality management system will help you:

• Assess the overall context of your organization to define who is affected

by your work and what they expect from you. This will enable you to
clearly state your objectives and identify new business opportunities.

• Put your customers first, making sure you consistently meet their needs
and enhance their satisfaction. This can lead to repeat custom, new
clients and increased business for your organization.
 ISO 9001: benefits
• Work in a more efficient way as all your processes will be aligned and
understood by everyone in the business or organization. This increases
productivity and efficiency, bringing internal costs down.

• Meet the necessary statutory and regulatory requirements.

• Expand into new markets, as some sectors and clients require ISO 9001
before doing business.

• Identify and address the risks associated with your organization

 Why was ISO 9001 revised?
• All ISO standards are reviewed and revised regularly to make sure they remain
relevant to the marketplace.

• ISO 9001 has been updated to take into account the different challenges that
businesses now face.

• For example, increased globalization has changed the way we do business and
organizations often operate more complex supply chains, and there are
increased expectations from customers.

• ISO 9001 needs to reflect these changes in order to remain relevant.

 What are the key improvements?
Structure
ISO 9001:2015 now follows the same overall structure as other ISO
management system standards (High-Level Structure), making it easier for
anyone using multiple management systems.

Focus on risk-based thinking

This has always been part of the standard, but the new version gives it
increased prominence.
More information can be found on the Website run by ISO/TC 176/SC 2, the
group of experts behind the standard (www.iso.org/tc176/sc2/public).
 What benefits does the
new version bring?

The new version of the standard brings the user a number of benefits.
ISO 9001:2015:
• Puts greater emphasis on leadership engagement

• Helps address organizational risks and opportunities in a structured

manner
• Uses simplified language and a common structure and terms, particularly
helpful to organizations using multiple management systems
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based organizations
 Should I be certified to ISO 9001?
• Certification - when an independent certification body audits your
practices against the requirements of the standard – is not a
requirement of ISO 9001, but is a way of showing stakeholders that you
have implemented the standard properly.

• For some companies, third- party certification may be a requirement. For

example, some governments or public bodies may only contract suppliers
that have been certified to ISO 9001.

• ISO does not perform certification. For more information about the
certification process, see www.iso.org and the publication ISO
9001:2015 – How to use it.
 How do I get started with ISO 9001:2015?
Key tips
Tip 1 – Define your objectives. Why do you want to implement the standard?

Tip 2 – Ensure senior management is on board. It is crucial that everyone is

supportive of the initiative and its objectives. The publications Reaping the
benefits of ISO 9001 and ISO 9001: Debunking the myths may help with this.

Tip 3 – Identify your organization’s key processes for meeting your objectives
and customers’ needs. Within each of these processes, ensure you understand
your customers’ requirements and can guarantee that these are met. This will
form the basis of your quality management system.
Examples of success with ISO 9001
ISO 9001 is used successfully all over the world. In 2013 alone, over one
million certificates to the standard were issued across 187 countries, and
many other companies and organizations have used the standard without
seeking certification.

Success with ISO 9001 can take many forms. For some enterprises, it is all about
attracting new clients, while others see it as the blueprint for internal
efficiency.
TRUTHS & MYTHS ABOUT
ISO-9000

55
OTHER MISCONCEPTIONS ARE AS FOLLOWS:

ISO-9000 CERTIFIED COMPANIES CAN ONLY

PURCHASE FROM ISO-9000 COMPANIES.
This is not true. An organization is only to maintain
records of acceptable suppliers whereas it is at liberty
to choose the criteria of acceptability which would
give consistent quality of supplies/goods. The past
performance can be an important guideline.

56
ISO-9000 IS ONLY REQUIRED BY BIG COMPANIES.
Not true. The size of company is not relevant as the
company could be producing quality items which
either are used independently or become a
component of a more sophisticated item. Of course
the ISO-9000 implementation and system could vary.

57
ISO-9000 IS ONLY FOR MANUFACTURING
ORGANIZATION
Not true. It is applicable to all sectors including
services like hospital, railway, hotel etc.

ISO-9000 IS ONLY FOR EXPORT INDUSTRY

Not true. The benefits are so large that whether you
sell locally or export, the system is beneficial.

58
THE SYSTEM IS BEURACRATIC AND RESULTS IN
INCREASED PAPER WORK
Not true. It can only prove bureaucratic if wrongly
understood and wrongly implemented. In fact it
brings together different departments but maintains
the necessary checks and balances. A company
usually has purchase orders, drawings and other
records. The ISO-9000 simply bring them together in
an organized way.

Continued 59
In some cases it is actually reduces red tape and paper
work written procedure/work instruction specifying
working methodologies are helpful as it may tell you
that staff is not doing as per your requirement. The
greater the training and skill of the manpower, lower
would become the needs for written instructions.

60
THE SYSTEM REQUIRES EXTRA STAFF
Not true. In fact a systematic working reduces rework,
error, results in lowering number of staff. In some
case a small firm need not employ a quality manager.
It may just give this work to an existing employee on
part time basis. In case of audit, one department can
audit another department. The system built up is, of
course important. It should be slim-line and
manpower well trained.

61
ISO-9000 SETS A SPECIFIC LEVEL OF QUALITY
Not true. One must differentiate between grade and
quality. The quality standards are set by the
requirements of the customers. ISO-9000 require the
maintenance of system that ensures consistent quality
at pre-determined level.

62
ONCE ISO-9000 CERTIFICATION IS ACHIEVED &
ORGANIZATION CAN RELAX ITS QUALITY SYSTEM
Not true. As certification companies carries out a six
monthly surveillance which is a part of three years
contract and an organization can lose its certificate in
case during surveillance it is discovered that a
company is not adhering to the ISO-system.

63
EXPLAINING SOME POINTS OF
CRITICISM
ABOUT ISO-9000

64
THE CO/ORGANIZATION HAS BEEN PRODUCING
QUALITY GOOD FOR MANY YEARS. WHY SHOULD IT
NEED AN ISO-9000 CERTIFICATE?
It is true that old-established companies/ organization
having loyal and regular customers with dedicated
workers feel cornered / cheated when new businesses
having ISO-9000 certification takes over their
business. One should really look at the relevance of
benefits of the ISO-9000 and then decide.

Continued 65
The standards are getting higher and competition
stiffer. Moreover, the ISO certification can prove to
the customer that an organization produces consistent
result. In any case if an organization has good system
it takes very little to fall in line with ISO-9000 and thus
achieve universality with international practices.

66
AN ORGANIZATION CAN PRODUCE POOR QUALITY
PRODUCTS DESPITE ATTAINING ISO-9000
It is not possible in practice to have good planning,
quality control, inspection, resting and other quality
system of ISO 9000 and still produce substandard low
grade products.
The ISO system assists you in producing a consistent
product with minimum chances of fault/defective
products. Despite ISO-9000 if there are defective
products it can lead to change in process or
machinery.
67
THE ORGANIZATION HAS GOOD SYSTEMS OF
WORKING-WHAT IS THE NEED OF CERTIFICATION?
It is true for such companies to feel that they do not
need to pay a certification body to prove their systems
quality. But checking by an external independent
agency is bound to be more rigorous than ones own
checking.

Continued 68
The system of independent verification is common
practice. For instance, one can not drive a car without
being assessed and certified. Moreover, external
auditor, have wide experience of scrutinizing a large
number of companies all over the world and have the
knowledge in avoiding quality problems. Their advice
could improve the business.

69
CERTIFICATION COSTS ARE HIGH
This criticism mostly comes from smaller
companies/organizations. It is true that costs in the
first year could be high. But it is possible to negotiate
spreading the payment over three years. Smaller and
similar companies can form cluster can get the
certification company representative to do their work
during their one visit. This is specially applicable to
Pakistan where the surveyors come from foreign
countries.

70
ADVANTAGES OF
ISO-9000

71
 For your employees:
1. Staff gets a better understanding of their role and
objectives, by having a documented management system.
2. They benefit from reduced stress levels, because they are
using an efficient management system and because they
know what is expected of them.
3. They get increased morale and a sense of pride through
achieving the goals of registration and customer
satisfaction.
4. New staff can immediately learn their job, because the
details are in writing.

72
 For your organization:
1. Your products will be of a more consistent quality, and
you will produce fewer rejects.
2. You gain cost savings, because your production will be
more efficient. There are economies in production
(because your systems are controlled from start to finish),
and economies in time that was formerly spend re-doing
work.
3. You can improve the quality of your raw materials by
requiring your suppliers to have a ISO 9000 system.
4. Export marketing is easier, because some foreign buyers
recognize ISO 9000 (BS 5750).

Continued 73
5. You can expect preferential treatment from potential
customers who have ISO 9000 certification. This means
an increase in new business.
6. You secure greater customer loyalty, because you
continuously satisfy their needs and give them no cause
to seek another supplier. That means you suffer fewer
customer losses.
7. You can use ISO 9000 in your publicity to win more sales.
8. ISO 9000 helps in minimize the risk of producing unsafe
products. It may also give you some protection law
against product liability claims.
9. Being first in your area or industry may put you ahead of
your rivals by 18 months to two years.

74
 For your customers:
1. Your customers get a known level of quality that is
independently audited.
2. They get a means of choosing between competing
suppliers.
3. They can have more confidence in your goods.
4. They can assess your quality system, and thus check your
ability to produce satisfactory goods and services.

75
 Quality
Management Principles

20/02/2019 76
Eight Quality Management Principles
 1 Customer Focused Organization
EXPECTATIONS

NEEDS CUSTOMER REQUIREMENTS

ORGANIZATION
 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 organization’s
objectives
 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 organization’s benefit.
Involvement is participation.
 4 Process Approach
• A desired result is achieved more efficiently when related resources
and activities are managed as a process

Resources

Transformation
Inputs Outputs
EXERCISE
Describe any Process?
 E.g. - Purchasing Process
Inputs Purchasing Outputs
• Required item / Procedure • Receipt of Materials
quantity / date on right conditions
• Applicable specs • Right Quality, Right
• Supplier source Quantity
• Suppliers capability Interactions to • Right Time.
to meet our •Storage
requirements •Inspection and Testing
•Manufacturing
•Finance

Performance Measurements
•Delivery status – On-time, On spec, etc
•Supplier evaluation
 5. System approach

conceptual presentation of QMS requirements

specified

Controls
(e.g.procedure)
(e.g.procedure)
Process Process
A C
Input Process Output
Activities
+ Process Process
Resources
B D

28
 CONTINUAL IMPROVEMENT

• Continual improvement should be a permanent

objective of the organization

Deming’s wheel
(P.D.C.A.)

PLAN DO

ACT CHECK Continuous

Improvement

ISO
9000
Factual Approach to Decision Making

• Effective decisions are based on the

analysis of data and information

Data Data
Decision
Collection Analysis
 8 Mutually Beneficial Supplier
Relationships
• An organization and its suppliers are interdependent, and a
mutually beneficial relationship enhances the ability of both
to create value