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Introduction

to
Quality Management System

By:
Directorate of Quality Management
(DQM)

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Objective

To understand terms and concepts of Quality

Management System (QMS) for Standardizing Systems

and Process within the Organization

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Directorate of Quality Management
Contents

1. What is Quality?
2. Quality in Society
3. Quality Evolution
4. What is QC & QA?
5. What is Quality Management?
6. What is ISO?
7. What is ISO 9001?
8. Misconception about Quality

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“It is most important that Top Management
be Quality minded. In the absence of
sincere manifestation of interest at the
top, little will happen below”
Joseph M. Juran

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DQM Introduction

i. Established in 2001 with mandate to monitor QA activities.


ii. Consultancy Support to more than 60 PAEC Establishments.
iii. 26 PAEC Establishments have been ISO 9001:2015 certified
iv. Provide QA support to different PAEC projects.
v. Conducting QA & Performance Audits of PAEC projects.
vi. Trained manpower
vii. Arranged more than 350 different Training programs.

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1. What is Quality?

Historical Development

 History of Quality is as old as Civilization

 High precision of measurements of Length,


Mass and Time by Harappans (2700BC)

 Dimensions of Pyramids (2500BC)

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1. What is Quality? Cont.…..

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1. What is Quality? Cont.…..

PIONEERS AND THEIR DEFINITIONS OF QUALITY:

Customer’s Requirements
Present and Future - DEMING

Fitness for Use - JURAN

Conformance to the
Requirements - CROSBY

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1. What is Quality? Cont.…..

Degree to which a set of inherent characteristics


fulfills a set of requirements.

(ISO 9000:2015)

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1. What is Quality? Cont.…..

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1. What is Quality? Cont.…..

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1. What is Quality? Cont.…..

Quality Parameters CUSTOMER REQUIREMENTS

QUALITY OF DESIGN

QUALITY OF REALIZATION
3

QUALITY OF USE

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1. What is Quality? Cont.…..
Quality Problems In Products

Poor product
Errors made during 30% design and
40% engineering
the manufacturing
process

30%

Non-conforming
materials purchased
from suppliers Courtesy International Trade Centre

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1. What is Quality? Cont.…..
Quality Problems
Responsibility of
In Management System workers
15%

85%
Responsibility of
Managers
(System Problems)

Courtesy International Trade Centre

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1. What is Quality? Cont.…..

Types of Quality

Quality is classified into following categories:

i. Item / Product Quality

ii. Service Quality

iii. Combination of Product and Service

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1. What is Quality? Cont.…..

Dimensions of Quality
1. Performance:

Will the product/service do the intended


job?

2. Reliability:
How often does the product/ service
fail?
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1. What is Quality? Cont.…..
Dimensions of Quality

3. Durability:

How long does the product/service last?

4. Serviceability:
How easy to repair the product / to
solve the problems in service?

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1. What is Quality? Cont.…..

Dimensions of Quality
5. Aesthetics:
What does the product/service
look/smell/sound/feel like?

6. Features:
The extras that are included beyond the
basic characteristics

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1. What is Quality? Cont.…..
Dimensions of Quality
7. Perceived Quality:
What is the reputation of the company
or its products/services?

8. Conformance to Standards:
Is the product/service made exactly as
the designer/ standard intended?

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2. Quality in different areas of society

Airline • On-time, comfortable, low-cost service

• Correct diagnosis, minimum wait time, lower


Health Care cost

Food Services • Good product, fast delivery, good environment

Postal • Fast delivery, correct delivery, cost containment


Services
• Proper preparation for future, on time
Academia knowledge delivery

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3. Quality Evolution

Total Quality
Management

Quality
Performance

Management
System

Quality
Assurance
Quality
Control
Mass
Inspection

Time
~1920 1920~1950 1950~1980 1980~
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4. What is Quality Control & Quality Assurance?
Quality Control?
Part of quality management focused on fulfilling quality
requirements. ISO 9000:2015

Quality Assurance?
Part of quality management focused on providing
confidence that quality requirements will be fulfilled.
ISO 9000:2015

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4. What is Quality Control & Quality Assurance? Cont......

Quality Control Quality Assurance

Product Process

Reactive Proactive

Find Defects Prevent


Defects
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5. What is Quality Management?

• Quality management includes all the activities that


organizations use to direct, control, and coordinate quality.
These activities include formulating a quality policy and setting
quality objectives.
• They also include Quality Planning, QC, QA and Quality
improvement.

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5. What is Quality Management? Cont......
Quality Management Principles

• Customer-focus
• Leadership
• Engagement of
7 QUALITY
People
MANAGEMENT
PRINCIPLES • Process Approach
• Improvement
• Evidence-based deci
sion making
• Relationship manage
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5. What is Quality Management? Cont......

PDCA Cycle

Act Plan

Check DO

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6. What is ISO?

• International Organization for Standardization


• Central Secretariat in Geneva, Switzerland
• An independent, non-governmental organization
• Membership of 164 national standards bodies
• World’s largest developer of voluntary international
standards

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6. What is ISO? Cont.……
• Operations began in February 1947
• Since then +22,000 International Standards and related
documents have been published covering almost every industry
• ‘International Organization for Standardization’ would have
different abbreviations in different languages
• IOS in English, OIN in French

• Decided to use a word derived from Greek ‘isos’ meaning equal


• Short form of organization is ISO in all countries & all languages
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6. What is ISO? Cont.……
Standards range
• Agriculture & construction
• Mechanical engineering to medical devices
• Information technology
• Popular standards include
- ISO 9001 (Quality management)
- ISO 14001 (Environmental management)
- ISO 45001 (Occupational health and safety)
- ISO 50001 (Energy management)
• ISO 9001 implemented in over 1 million organizations in over
170 countries
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6. What is ISO? Cont.……
Certification Body & Accreditation Board

• ISO 9001 registration is done by certification bodies


• Certification body is further affiliated to an
accreditation board, a public sector organization, like:
- Pakistan National Accreditation Council (PNAC)
- United Kingdom Accreditation Services (UKAS)

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7. What is ISO 9001?
Fifth Revision

ORIGIN OF ISO 9001 Forth Revision


Third Revision • ISO 9001:2015

Based Second Revision


STAGES OF DEVELOPMENT

on Mil Std 9858 • ISO 9001:2008


& BS : 5750 First Version • ISO 9001:2000
OF ISO 9000 QMS

• ISO 9001
Initial Draft • ISO 9002
of ISO 9000 • ISO 9003
ISO 9000

Prepared by
26 Countries

1985 1987 1994 2000 2008 2015


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7. What is ISO 9001? Cont.…….
Clauses of ISO 9001:2015
Clause 1 Scope
Clause 2 Normative references
Clause 3 Terms and definitions
Clause 4 Context of the organization
ISO has
introduced a Clause 5 Leadership
common Clause 6 Planning
structure for all
management Clause 7 Support
system Clause 8 Operation
standards
Clause 9 Performance evaluation
Clause10 Improvement
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7. What is ISO 9001? Cont.…….
Three Standards of ISO 9000 Series

ISO 9000: 2015 ISO 9001: 2015 ISO 9004: 2018


Managing for the
Quality sustained success
Management Quality of an Org.
Systems Management A Quality
Fundamentals Systems Management
and Vocabulary Requirements Approach

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8. Quality is not like this (x)

Quality Manuals & Procedures sit


on shelves

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The actual production of documents
is seen as the primary objective
QA Engineer

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8. Quality is not like this (x) – Cont.…..

QUAL IT Y
Qu a li t y
is MY
Bu sin e ss

QUALITY QUALITY QUALITY

Quality is the role of QA Department


RECORDS RECORDS RECORDS

1069_28.pre

Quality has been considered to be all


about obtaining signatures

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Suggested Standards/ Books

1. ISO 9001:2015 QMS Requirements Standard

2. ISO 9000:2015 QMS Fundamentals & Vocabulary

3. Certified Quality Engineer Handbook, ASQ

4. The Quality Audit Handbook by J.P. Russels

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Directorate of Quality Management
Contact Details of DQM

Directorate of Quality Management (DQM)


P.O. Box 2137, Islamabad
Phone: 051-2612021
Fax: 051-2612109
Email: dqa@paec.gov.pk, dd_dqa@paec.gov.pk

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Directorate of Quality Management
Thank you for your attention

…Questions and Suggestion?

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