QUALITY

MANAGEMENT
SYSTEMS
BITS Pilani
MBA/QMZG524
Pilani Campus MATHEW PAUL VIZHALIL
 BITS Pilani
Pilani Campus

MBA/QMZG524 QUALITY
MANAGEMENT SYSTEMS
Lecture No. 1
INFORMATION

FACULTY: MATHEW PAUL VIZHALIL

For course related queries, my email id:

mathew.vizhalil@wilp.bits-pilani.ac.in

For administrative and other queries, please contact BITS

WILP section directly

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TODAY’S OBJECTIVES

 INTRODUCTION
 EVOLUTION OF QUALITY
 EVOLUTION OF ISO AND STANDARDS

BITS Pilani, Pilani Campus

EVOLUTION OF QUALITY

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

EVOLUTION OF QUALITY

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY EVOLUTION

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

JOURNEY

Self Inspection

control by Inspection ??

Probability theory-
Sampling
towards SPC & beyond
movement/progress

SQC

Schewart control chart-

statistical process control
Quality assurance

Taguchi/TQC/TQM

ISO, QMS

Six sigma, Lean etc.

1925 World 1950 1987 1994 2000 2008 2015

war II

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

EVOLUTION OF QUALITY

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

EVOLUTION OF QUALITY

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY EVOLUTION

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY EVOLUTION

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY EVOLUTION

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY EVOLUTION

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY - DEFINITIONS

1) Perfection
2) Consistency
3) Eliminating waste
4) Speed of delivery
5) Compliance with policies and procedures
6) Providing a good, usable product
7) Doing it right the first time
8) Delighting or pleasing customers
9) Total customer service and satisfaction

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY - DEFINITIONS

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956

QUALITY -DEFINITION
(ASQ)
Quality: A subjective term for which each person or sector
has its own definition. In technical usage, quality can
have two meanings: 1) the characteristics of a product or
service that bear on its ability to satisfy stated or implied
needs; 2) a product or service free of deficiencies.
According to Joseph Juran, quality means “fitness for
use”; according to Philip Crosby, it means “conformance
to requirements.”

BITS Pilani, Pilani Campus

EVOLUTION OF
MANAGEMENT
1st Generation : Just do it yourself.
2nd Generation : Telling others what and how to do it?
3rd Generation : Management by objectives - Set Targets
Three ways people reacted to this change:
a- Improve the system
b- Distort the system
c- Distort the figures
4th Generation : Managers know that results can be
attained only by fundamental improvements. They
become champions of customer needs which are drivers
of real improvement.

BITS Pilani, Pilani Campus

DEFINITION OF QMS (ASQ)

A quality management system (QMS) is defined as a

formalized system that documents processes,
procedures, and responsibilities for achieving quality
policies and objectives. A QMS helps coordinate and
direct an organization’s activities to meet customer and
regulatory requirements and improve its effectiveness
and efficiency on a continuous basis.

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QMS HELPS

QMS helps to serve the purposes like

•Improving processes
•Reducing waste
•Lowering costs
•Facilitating and identifying training opportunities
•Engaging staff
•Setting organization-wide direction

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BENEFITS OF QMS

• Meeting the customer’s requirements, which helps to

instill confidence in the organization, in turn leading to
more customers, more sales, and more repeat business
• Meeting the organization's requirements, which ensures
compliance with regulations and provision of products
and services in the most cost- and resource-efficient
manner, creating room for expansion, growth, and profit.

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ADVANTAGES OF
SYSTEMATIC QMS

With QMS Without QMS

Increase in Sales 69% 32%
Gain in operating revenue 91% 43%
Growth in number of Employees 23% 7%
Increase in Return on Sales 8% 0

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ELEMENTS OF QMS

The organization’s quality policy and quality objectives

Quality manual
Procedures, instructions, and records
Data management
Internal processes
Customer satisfaction from product quality
Improvement opportunities
Quality analysis

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ESTABLISHING AND
IMPLEMENTING QMS
• Design
• Build
• Deploy
• Control
• Measure
• Review
• Improve

The structure is largely based on PDCA cycle and allows

for continuous improvement for Product and QMS

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3S TO 3P

Strategy to Purpose
Structure to Process
Systems to People
OLD WAY :
Top-level managers view themselves as the designers of the
strategy, the architects of the structure, and the managers
of the systems that direct and drive their companies.
GM and IBM in the United States, Philips and Daimler-Benz
in Europe, and Matsushita and Hitachi in Japan can be
traced, at least in part, to top management’s cleaving to
this philosophy too tightly and for too long.

BITS Pilani, Pilani Campus

3S TO 3P

NEW WAY :
Leaders place less emphasis on following a clear strategic
plan than on building a rich, engaging corporate purpose.
Next, they focus less on formal structural design and more
on effective management processes.
Finally, they are less concerned with controlling
employees’ behavior than with developing their
capabilities and broadening their perspectives.

3M , Canon , AT&T, Royal Dutch/Shell, Intel, Andersen

Consulting, Kao, and Corning from succumbing to the so-
called inevitable decline of large corporations?
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International organization
for Standardization
• 162 member bodies-(Geneva)
• About 22000 standards so far.
• Technical committees,
Sub committees and work groups
• Draft International Standards--
to member bodies for approval
• At least 75 % approval for acceptance by ISO council.
• Technical specification for 3 years (TS)
• Protocol for review every 5 years

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WHAT IS ISO ?

The International Organization for Standardization (ISO) is

a worldwide federation of national standards bodies from
more than 145 countries, with one body representing
each country.
ISO is a non-governmental organization established in
1947 and based in Geneva, Switzerland.

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WHAT IS ISO ? (Continues)

Its mission is to promote the development of

standardization and related activities in the world; to
facilitate the international exchange of goods and
services; and to develop cooperation in intellectual,
scientific, technological and economic activity. ISO's
work results in international agreements, which are
published as International Standards and other types of
ISO documents.

BITS Pilani, Pilani Campus

DEFINITON OF STANDARD

The International Organization for Standardization (ISO)

defines a standard as a "document, established by
consensus and approved by a recognized body, that
provides – for common and repeated use – rules,
guidelines or characteristics for activities of their results,
aimed at the achievement of the optimum degree of
order in a given context

BITS Pilani, Pilani Campus

PURPOSES OF
STANDARDS
• Determining the fitness of an object or process for a
specific purpose or its compatibility and
interchangeability with other objects or processes
• Contributing to safety
• Providing protections for the environment
• Providing for product protections against climatic or other
adverse conditions

BITS Pilani, Pilani Campus

BENEFITS OF STANDARDS

ISO standards add value to all types of businesses and business

operations. They contribute to making the development, manufacturing,
and supply of products and services more efficient, safer, and cleaner.

ISO standards also serve to safeguard consumers and users of products

and services in general as well as to make their lives simpler.

For businesses, the widespread adoption of international standards means

that suppliers can base the development of their products and services
on reference documents that have broad market relevance.

For customers, a product or service based on an international standard will

be compatible with more products or services worldwide, which increases
the number of choices available.

BITS Pilani, Pilani Campus

STANDARDS
DEVELOPMENT
Key principles in standard development
1. ISO standards respond to a need in the market

2. ISO standards are based on global expert opinion

3. ISO standards are developed through a multi-

stakeholder process

4. ISO standards are based on a consensus

BITS Pilani, Pilani Campus

MANAGEMENT SYSTEM
STANDARDS
A management systems standard is what an organization
does to manage its processes or activities so that the
products or services that it produces meet the objectives
it has set itself, such as:

• Satisfying the customer's quality requirements

• Complying with regulations
• Meeting environmental objectives

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EVOLUTION OF MANAGEMENT
SYSTEMS STANDARDS

1987
First ISO 9000 Series published. Based on BS 5750

1994
Three Certification standards
20 Elemental approach focused on producing products at
consistent quality level.

2000 (ISO-9000,9001, 9004)

Elemental to Process Approach( Deming-PDCA)
Single Certification Standard.

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EVOLUTION OF MANAGEMENT
SYSTEM STANDARDS - CONTINUES

2008 ( (ISO-9000,9001, 9004) +19011:2002+ guidance

documents)
No significant changes. Mostly clarifications

2015 ((ISO-9000,9001, 9004) +19011:2011+ guidance

documents )

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LIST OF OTHER
STANDARDS
ISO-14001-2015 Environment Management System
ISO-21000-2018 Educational Management systems
ISO 27010-2015 Information security management
ISO 22000-2018 Food safety management.
ISO-13485-2016 Medical devices — Quality management
systems — Requirements for regulatory purposes.
ISO-15378-2017 Primary packing for medicinal products.
ISO 45001:2016 Occupational health and safety management systems

ISO-9001 is the base for IATF 16949, and Aerospace AS 9100

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ISO 9000 SERIES OF
STANDARDS

ISO 9001:2015: Quality Management Systems – Requirements

ISO 9000:2015: Quality Management Systems - Fundamentals and

Vocabulary (definitions)

ISO 9004:2018: Quality Management - Quality of an Organization -

Guidance to Achieve Sustained Success (continuous improvement)

ISO 19011:2018: Guidelines for Auditing Management Systems

BITS Pilani, Pilani Campus

 Plan-Do-Check- Act cycle

Organization and its

Quality Management System (4)
context (4)

Support &
Operation
(7.8)

Do Customer Satisfaction

Plan
Performan
ce
Customer Planning Results of
requirement (6)
`
Leadership
(5)
evaluation
QMS
(9)

Check Products and services

Needs and
expectations of Act
relevant interested
parties (4) Improvem-
-ent
(10)

Structure of this International standard in PDCA

Ref: ISO 9001: 2015
FUNDAMENTALS

• QMS 7 Principles
• PROCESS APPROACH/MANAGEMENT
• RISK BASED MANAGEMENT
• PDCA
• High Level Structures

PS: We will be going through each one in subsequent

Lectures.

BITS Pilani, Pilani Campus

WHAT WE COVERED
TODAY
 INTRODUCTION
 EVOLUTION OF QUALITY
 EVOLUTION OF ISO AND STANDARDS

BITS Pilani, Pilani Campus

THANK YOU

BITS Pilani, Deemed to be University under Section 3 of UGC Act, 1956