QUALITY

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

MBA/QMZG524 QUALITY
MANAGEMENT SYSTEMS
Lecture No. 2
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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RECAP

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

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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

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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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.”

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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.

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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

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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

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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.

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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

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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

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 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
TODAY’S OBJECTIVES

To get conversant with important terminology and

definitions related to Quality, Quality Management and
QMS , etc.
QMP

REF: ISO-9000:2015
Quality Management systems-Fundamentals & Vocabulary

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VOCABULARY &
TERMINOLOGIES
Terms have been systematically grouped as follows and defined as related to:
• Person/people
• Organization
• Activity
• Process
• System
• Object/Requirement
• Result
• Data, information and document;
• Customer
• Characteristic
• Determination
• Action
• Audit.

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CONCEPT DIAGRAMS

REF ISO 9000:2015 Page No 34 to 46

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VOCABULARY &
TERMINOLOGIES
CONCEPTS DIAGRAMS WHAT WE HAVE SEEN:
• Person/people
• Organization
• Activity
• Process
• System
• Object/Requirement
• Result
• Data, information and document;
• Customer
• Characteristic
• Determination
• Action
• Audit.

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CUSTOMER (3.2.4)

Person or organization that could or does receive a product or a

service that is intended for or required by this person or
organization.
EXAMPLE
– Consumer, client, end-user, retailer, receiver of product or
service from an internal process beneficiary and purchaser.
– The boss/management/organization; family of the
patient/student.
– The next process.
Note : A customer can be internal or external to the organization.

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QUALITY –DEFINITION 1

• degree to which a set of inherent characteristics (3.10.1)

of an object(3.6.1) fulfils requirements(3.6.4)
• Terms to be understood:
– Requirements
– Characteristics
– Inherent
– degree

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QUALITY (3.6.2) continues

– Requirements: Need or expectation that is stated, generally

implied or obligatory. (3.6.4)
– Characteristics: A distinguishing feature (3.10.1)
(various classes of characteristics-physical, functional,
ergonomic etc)
– Inherent: characteristics built into the product/service –as
against assigned--.
– degree: Extent to which the requirements are fulfilled-e.g high,
medium, low, bad etc.

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QUALITY (3.6.2) continues

distinguishing feature:
can be inherent or assigned.
can be qualitative or quantitative.
various classes of characteristics:
quality characteristic: inherent characteristic (3.10.1) of
an object (3.6.1) related to a requirement (3.6.4).

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QUALITY- DEFINITION 2

Conformance to specified requirements

•Whose requirements??
•Customers, statutory/regulatory bodies, society.
•Requirements are converted to characteristics to be built
into the product/service through:
• -PO/DRAWING/SAMPLE
• -DESIGNER-DRAWING
• -STANDARDS-DATA SHEETS
• -CONTROL PLANS ETC
• -VERBAL INSTRUCTIONS
• Statutory/regulatory requirements are to be collected/compiled.

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Requirement v/s Characteristic
(Examples)

Product/ser Requirement Related characteristics

vice
Food Grinding of Motor HP & RPM; design & material
processor spices of blades;
Easy chair Seat, back, Sizes, angles as per GRADE of chair.
proper height.

Strength Material of construction

Data Timely and Systems, responsibility for collection
reliable, and transmission,
relevant.
Handkerchief Handy, Different sizes for choice-separate
range for ladies.
Moisture Specifications of cloth to be used.
absorbent,
Aesthetic Designs on borders; prints etc.
 Requirement v/s characteristic
(Examples) contd.

Product/ REQUIREMENT Related characteristics

service
Software 1. No error in 1.Regression testing of code.
for the Calculations; 2.Unit testing, peer review and superior review.
backend 2. Defect free code. 3.Made for MAINFRAM computers to keep it live
of the 3. Soft ware to support 24X7.
bank staff. 24X7. Etc.
Anti- (i) Protection of the 1. Feature of arming /disarming / integration of
intrusion property. different type of sensors.
alarm (ii)Low insurance cost. 2. Embedding into the system adequate
system (iii)Proper police response. communication option to maintain stations.
(iv) Easy to operate. (Here adequate is as decided by the org.).
3. Visible/audible indicators.

Door -power or manual -Fluid to be used, its further characteristics like

operating -to close gradually. viscosity;
system -but not too slow. -time to close –within ----seconds;
-Bearing –make, size etc.
Etc.
QUALITY (CONTINUES)

• TYPES OF QUALITY

• Quality of design/grade decides the characteristics of the product in

reference to customer requirements.
• Quality of conformance means satisfying the designed standard to ensure
performance levels.

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 Requirements (of
customer)

Characteristics
(Requirements of Quality of
the organization) Design

PRODUCT

Non conforming (not Conforming

fulfilling one or more (fulfilling Quality of
requirements). requirements Conformance
of
organization)
DEFECT( Not fulfilling a
requirement related to
intended/specified use )
FUNDAMENTAL CONCEPTS
(ISO 9000:2015)
General:
- QMS enables the organization to meet challenges that are
profoundly different from those encountered in recent past.
- Challenges:
- Accelerated change
- Globalization of market
- Knowledge as a principle resource
- Knowledge and demanding customers.
- The standard provides direction to organization’s approach to
quality.
- All concepts of this standard should be seen as a whole and not in
isolation.

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QUALITY MANAGEMENT
SYSTEM (3.5.4)
- part of a management system (3.5.3) with regard to quality (3.6.2)

OPRV(Objectives, Processes, Resources, Value)

- QMS comprises of a set of interacting/interrelated activities by which the organization:

• Identifies its quality related objectives,
• Determines the processes and
• Determines the resources needed to meet the objectives.
- QMS manages the interacting process and resources required to provide value to all
interested parties.

- QMS enables the Top Management to optimize the use of resources considering the
long term and short term goals and consequences of their Strategies and decisions.
- QMS also enables to identify actions to address intended and unintended
consequences in providing products and services.

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QUALITY ASSURANCE
(3.3.6)
- part of quality management (3.3.4) focused on providing confidence that quality
requirements (3.6.5) will be fulfilled.

Quality Assurance –Set of processes which assure that the quality requirements shall
be fulfilled. This is done by building quality during manufacturing process. Quality is
manufactured and not inspected and aim is to eliminate inspection.
- It assures processes by pro-active approach and is based on process root cause
analysis, FMEA and SPC etc.
It has following steps:-
1. Identify the customers.
2. Determine the needs of customers.
3. Translate needs into your language.
4. Develop product features that can be optimally respond to these needs.
5. Develop a process that is optimally able to produce the product features.
6. Transfer the process to operating people.

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QUALITY CONTROL (3.3.7)

-part of quality management (3.3.4) focused on fulfilling quality requirements(3.6.5)

Quality Control-

More commonly known as Inspection. It involves checking a product for acceptance or

rejection based on whether it meets the specification criteria or not. This is a reactive

approach based on quality of inspection.

It has following steps:-

1. Evaluate actual quality performance.

2. Compare the actual to quality goals.

3. Act on differences.

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QMS TERMS 1

MANAGEMENT SYSTEM (3.5.3)

Set of inter-related or interacting elements of an organization to establish
policies/objectives , and processes to achieve those objectives .
QUALITY MANAGEMENT (3.3.4)
Management with regard to QUALITY.
QUALITY MANAGEMENT SYSTEM (3.5.4)
Part of a management system with regards to Quality.
QUALITY MANAGEMENT SYSTEM REALIZATION(3.4.3)
Process of establishing, documenting, implementing, maintaining and continually
improving a QMS

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QMS TERMS 2

Quality Objective (3.7.2) - objective(3.7.1) related to quality (3.6.2)

Quality Objectives – Based on Company’s quality policy all functions decide

the quality objectives. Those are measurable, within time frame and
responsibility is defined.

These cascade from Top to bottom to achieve Co’s overall goals.

Examples are:-
- Product performance
- Competitive Performance
- Quality Improvement
- Cost of poor quality
At the lowest level of Hierarchy the quality goals are based on Technological
basis.

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EXAMPLES (Are these right
?)
• To adopt new methods for quality improvements every year.
•  To Strive For 100% On Time Delivery
•  Maintain all suppliers in either A or B grade
•  To improve customer satisfaction level
•  To reduce breakdown time in machines
•  To increase profit by minimum 10% annually.
•  To complete all projects in time as required by the contractual agreements.
• Reduction in Process Time by minimum 10% every six months 
• To reduce rework by minimum 2% on Six monthly basis.
 
•

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QMS TERMS 3

Quality Policy (3.5.9)

- policy (3.5.8) related to quality (3.6.2)
It is a guide to managerial action. It is a statement of long term
intentions/directions of the organization w.r.t QUALITY.
Policy differs from a procedure which details how activities shall be
done.
eg. It is the policy of the company to provide products and services of
a quality that meets the present and future expectations and needs
of the customer by continual improvement. The Co wants to be the
leader in the product quality reputation.
-In order to progress towards this policy, the organization shall develop
and implement many processes /procedures (in accordance with
QMS)

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QMS TERMS 4

Process (3.4.1)
Set of interrelated or interacting activities that use inputs to deliver an
intended result.
Output (3.7.5)
Result of a process.
Product(3.7.6)
Output of an organization that can be produced without any interaction
taking place between the organization and the customer.
Service (3.7.7)
Output of an organization with at least one activity necessarily performed
between the organization and the customer.
Object (3.6.1)
Entity, item, anything perceivable-e. g
Product, service, process, person, organization, system, resource
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QMS TERMS 5
Top Management (3.1.1)
Person or a group of persons who directs and controls an organization
(3.2.1) at the highest level.
Customer
Person or organization(3.2.1) that could or does receive a product or a
service that is intended for or required for this person or organization.
Improvement(3.3.1)
Activity to enhance performance (3.7.8)- - - - - - (continual).
Nonconformity (3.6.9)
Non fulfillment of a requirement.
Defect (3.6.10)
Nonconformity related to an intended use or specific requirement

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QMS TERMS 6

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QMS TERMS 6 (continues)

• Verification (3.8.12)
• Confirmation, through the provision of objective evidence(3.8.3) ,
that specified requirements have been fulfilled.
• (Applies to design ; also to processes where it is called qualification
process )
• Validation (3.8.13)
• Confirmation, through the provision of objective evidence (3.8.3),
that the requirements (3.6.4) for a specific intended use or
application have been fulfilled.
• (Applies to design, process , system, instrument/software etc.)

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QMS TERMS 7

Competence (3.10.4)
Ability to apply knowledge and skills to achieve intended
results.
Capability(3.6.12)
Ability of an object(3.6.1) to realize an output(3.7.5) that
will fulfil the requirements (3.6.4) for that output.

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QMS TERMS 8

System(3.5.1) set of interrelated or interacting elements.

Organizations like human beings are adaptive and comprise of
interacting systems. Each needs ability to change.
- QMS recognizes that all systems, processes and activities cannot,
be predetermined and therefore need to be flexible and adaptable.
System:
Organizations seek to understand internal and external context to
identify the needs and expectations of interested parties
- The information is used to develop QMS to achieve
organizational sustainability.
- The input and output of each process are interlinked into
the overall net work.
- Every organization is unique and has its own QMS.

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QMS TERMS 9

Process (3.4.1) set of interrelated or interacting activities that use

inputs to deliver and intended result
Processes :
Organization has processes that can be measured, defined and
improved.
The processes interact to deliver results consistent with the objective
and cross functional boundaries.
Some processes are critical.
Activity:
People collaborate within a process to carry out daily activities.
Some activities are prescribed and depend on understanding of the
objectives.
Some are not prescribed to enable them to react to external stimuli.

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WHAT ISO 9001: 2015
REQUIRES
WHAT
THE ISO-9001 REQUIRES THE ORGANISATION TO:-

-Determine the needs and expectations of customers and other interested

parties

-Establish policies , objectives and environment to satisfy the above needs.

-Design, deploy and manage a system of interconnected processes necessary

to implement the policy and attain objectives.

-Measure, analyse and evaluate the effectiveness of each process in meeting

the objective.

-Pursue continual improvement.

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HOW ISO 9001:2015 DOES

HOW
-Determine what is required to be done.

-Convert into clear and unequivocal instruction..

-Confirm it is followed.

-Check everyone has knowledge ,ability to do the job and train if

necessary.

-Check if job has been done correctly.

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MAIN CLAUSES (ISO
9001:2015)
• Clause 4—Context of the organization +.
• Clause 5---Leadership
• Clause 6- Planning.
• Clause 7- Support.
• Clause 8- Operation.
• Clause 9--Performance evaluation.
• Clause 10-Improvement

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 ISO 9001:2015

ISO-
9001:2015

Cl. 4
Context of the
organization +

Cl. 5 Cl. 7 Cl.9

Leadership Performance
Support evaluation

Cl. 6 Cl.8 Cl.10

Planning Operation
Improvement

7 clauses, each representing a group of generic

processes applicable to any type of organization.
 Sequence and interaction of QMS processes at macro level

Context & needs

of interested
parties cl 4. Leadership &
Planning cl 5 & 6

Performance
Customer Evaluation Improve
requirements Support cl 7 Cl 9 ments
Cl 10

Operations cl 8
Products &
services as
required
 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
QMP

Objective:
– What are the 7 QMP’s
– Significance of the QMP’s.
– Understanding the QMP’s.
– Role played by QMP’s in building the QMS of the
organization.
– etc

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QMP
- ISO 9000: 2015 has defined QMP,s in clause 2.3

- The Seven principles are:-

1. Customer Focus. 2. Leadership

3. Engagement Of People 4. Process Approach

5. Improvement 6. Evidence based

Decision making
7. Relationship Management
These principles form the CONTEXT of how to interpret the SECTIONS of the
Standard. Methods may change or evolve , but principles do not.

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Customer Focus
What this means:
 Understand the needs of current and future customers
 Meet all customer requirements
 Strive to exceed customer expectations.
How do I do it ?
 Recognize that survival is based on dependence upon the customer
 Align targets set in your planning to address customer changes
 Target customer perceptions, current and future
 Formally review contracts and be realistic in your capabilities
 Record and analyze complaints and returns to determine gaps from those
commitments made
 Offer consumer value through preferred products and services
-Key Benefits:
 Delighted customers and resulting in customer satisfaction and Loyalty
 Enhanced business share.
 Increased customer- base.
 Increased profitability.
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Leadership
What this means:
 Establish unity of purpose and direction for your organization by going first through
your Vision and Mission
 Set policy and objectives that inspire and challenge
 Establish your organization’s internal culture, in which employees are partners in
achieving the organization’s objectives.
How do I do it ?
 Set clear goals and objectives: have and organizational “compass”
 Share and Communicate
 Treat quality as strategic issue and identify the financial effects of failing to meet these
goals
 Provide human and physical resources so your organization can achieve its objectives
 Coordinate lower-level objectives to align with top level so everyone is pulling in the
same direction
-
Key Benefits:
 Increased effectiveness and efficiency due to co-ordination of actions at all levels
 Improved communication due to participative management
 Delivery of desired results due to development and participation of people

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Engagement of People
What this means:
 Fully develop the abilities and competencies of your people
 Give people the freedom to use their abilities to achieve maximum benefit
How do I do it ?
 Maintain a high level of communication between leadership and employees
 Position your people in roles that match their abilities and competencies
 Integrate your human resources plan with your strategic business plan
 Conduct active and value-added training and process qualification activities
 Encourage employees to contribute to your organization’s improvement strategy
 Promote participation and empower people to take decision
 Align employees daily work tasks with the overall objectives of the organization.
Key Benefits:
 Improved understanding of company objectives
 Enhanced motivation and involvement of people in meeting the objectives
 Enhanced personal development , initiatives and creativity
 Increased trust, satisfaction and collaboration throughout the organization

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PROCESS APPROACH

To be discussed separately

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IMPROVEMENT
What this means:
 Make improvement a permanent objective for the organization
 Focus on improvement will lead to maintaining current levels of performance, react to
changes both internal and external and create new opportunities.
How do I do it ?
 Focus on process improvement to achieve business results
 Identify critical items and strategically allocate resources to improve what matters
 Provide resources to ensure that targets are met
 Develop and operate mature corrective action loops.
 Set new realistic goals once the targeted level is achieved
 Strive to achieve stretch improvement goals
 Seek to prevent defects, and to reduce variation and waste in supply chain

Key Benefits:
 Improved performance, customer satisfaction and meeting objectives
 Enhanced ability to react to internal and external risks and
opportunities
 Innovative and learning organisation

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EVIDENCE BASED
DECISION MAKING
What this means:
 Base decisions on logical analysis of objective data and information
 Quantify the business case for the action

How do I do it ?
 Focus on data such as audit results, performance reviews, corrective actions , and
complaints to improve customer satisfaction , and focus on internal metrics for internal
customer satisfaction
 Ensure data to be reliable, accurate and recent
 Make data to be available to all as per need (Need to know basis)
 Observe short- and long-term trends and indicators of performance to minimize
immediate issues and to foresee risk
 Use data to continually improve your organization’s performance

Key Benefits:
 Improved decision making
 Improved operational effectiveness and efficiency
 Improved assessment of process performance and ability to achieve objectives
A very simple (but effective) case: one company drastically reduced the amount of
uneaten food in their canteen simply by weighing and displaying everyday the
weight of the uneaten food being wasted
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RELATIONSHIP
MANAGEMENT
What this means:
 Create value through mutual, beneficial, interdependent relationships with interested
parties
How do I do it ?
 Determine relevant interested parties (such as suppliers, partners, customers,
investors, employees, and society as a whole) and their relationship with the
organization
 Determine and prioritize interested party relationships that need to be managed
 Establish relationships that balance short-term gains with long-term considerations;
 Define and document requirements to be met by relevant interested parties and show
clear linkage to end-user requirements
 Evaluate interested parties ability to meet requirements and match the requirements
according to risk
 Work with interested parties to develop mutual trust ,respect and commitment to
customer satisfaction
 Integrate key elements of your organization’s QMS with interested parties’ quality
improvement process.

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RELATIONSHIP MANAGEMENT
(Continues)
Key Benefits:
 Enhanced overall company ‘s performance
 Capability to create value to customers
 Capability to manage risks and competition
 Stable supply chain resulting in consistent flow of products and
services

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7 Principles at a glance

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WHAT WE COVERED
TODAY

Getting conversant with important terminology and

definitions related to Quality, Quality Management and
QMS , etc.
QMP

REF: ISO-9000:2015
Quality Management systems-Fundamentals & Vocabulary

BITS Pilani, Pilani Campus

THANK YOU

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