Sample Copy. Not For Distribution.1.5 ISO 9001:2015 standard requirements 23 1.6 Achieving ISO 9001...

Sample Copy. Not For Distribution.

i

ISO9001:2015 Quality Management System Requirements, Interpretation and Implementation


ii

Publishing-in-support-of,

EDUCREATION PUBLISHING

RZ 94, Sector - 6, Dwarka, New Delhi – 110075 Shubham Vihar, Mangla, Bilaspur, Chhattisgarh – 495001

Website: www.educreation.in _____________________________________________________________________________

© Copyright, Author

All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted, in any form by any means, electronic, mechanical, magnetic, optical, chemical, manual, photocopying, recording or otherwise, without the prior written consent of its writer.

ISBN: 978-1-5457-1849-0

Price: Rs.1914.00

The opinions/ contents expressed in this book are solely of the author and do not represent the opinions/ standings/ thoughts of Educreation.

Printed in India


iii

ISO9001:2015 Quality Management

System Requirements, Interpretation and Implementation

By

Dr. Ramesh R. Lakhe Director,Shreyas Quality Management System, Nagpur, India.

Mukesh Singhal Chairperson & Managing Director,URS Certification Ltd.

Dr. Rakesh L.Shrivastava Professor of Mechanical Engineering,YCCE, Nagpur, India

Dr. Balkrishna E. Narkhede Associate Professor, National Institute of Industrial Engineering, Mumbai, India

Kranti Dharkar Senior Consultant,Shreyas Quality Management System, Nagpur, India.

EDUCREATION PUBLISHING

(Since 2011)

www.educreation.in


iv


v

ABOUT THE BOOK

ISO 9001:2015 quality management system has become part of the requirement of all the

organizations, small to large, service as well as manufacturing. Over the years, ISO 9001

QMS, has evolved, as per the organizations requirement, and has become very important

for improving organizations systems and processes in order to sustain competitive

advantages. This book focuses on requirements and key features of ISO 9001:2015 QMS

such as risk based thinking, PDCA approach, process management, and continual

improvement. The readers would find it easier to understand the standard requirements

and implement these in their work place.

Salient features

1. Each Clause and sub Clause is illustrated through block diagram for easy

understanding

2. Numerous examples , case examples and case studies from different organizations for

the benefit of the readers

3. Standard requirements expressed through process approach, PDCA cycle and W-H

questions

4. Pedagogical tools such as chapter objectives, audit questions, flow diagrams, learning

assessments and multiple choice questions have been used.

5. Special focus on risk based thinking and documented information provided.

6. Management discussions to illustrate the Clause requirements are included for better

understanding and readability. The forms and formats, key performance

indicators/objectives, standard operating procedures and audit requirements are

included.


vi

PREFACE

This book provides a fundamental, yet comprehensive, coverage of ISO 9001:2015

Quality Management System (QMS). It covers not only the clauses, principles and

practices but also the various ways and techniques for its successful compliance to

the standard requirement and implementation. A practical state of the art

approach, based on training and consultancy experience, is adopted and presented

throughout the book. Sufficient explanations with examples are provided to ensure

that the reader has a sound understanding of requirements of ISO 9001:2015 QMS.

The complex clauses of the standard are interpreted in a simple way and developed

in the form of block diagrams, Plan-Do-Check-Act and Input-Process-Output form.

The book will serve the instructional and implementation needs of business, education,

engineering, organizations both manufacturing and service, consultants, auditors, ISO

group members and technology and management students in higher educational

institutions. All sizes and types of organizations-service, manufacturing, public sector,

government, municipal corporation, healthcare, construction, pharma, small businesses,

education and profit, non-profit entities-will find this book an excellent reading and

reference material, for all personnel, for training and implementation of ISO 9001:2015.

This book is organized in eleven chapters. Chapter one provides the details about ISO

9001 QMS, its development, principles of management, and basic premises such as

PDCA cycle, risk management approach etc. and ISO 9001:2015 introduction. Chapter

two to chapter eleven covers clauses of ISO 9001:2015 from clause 4, ―contextual issues‖

to clause 10, ―Improvement‖. Clause 7, ―Support‖ is divided in two parts i.e. Chapter 6

and 7 while clause 8 is divided into chapter 8, 9 and10. The abbreviations used in the

book are given at the end of the book.

The book provides the case examples, case studies and audit questions for understanding

the requirement of the standard.

It is very critical for organization to develop a comprehensive perspective on ISO

9001:2015. Therefore the efforts have been made to capture the practices and integrate


vii

them with well-established techniques to help organizations establish their ISO

9001:2015 Quality management system effectively.

Though every effort has been made to make the book precise and concise, still there is

further scope for improvement. We would be grateful to the readers and reviewers if they

provide their valuable inputs and suggestions for making this book more useful to the

individuals and organizations.

Dr. Ramesh R. Lakhe

Mr. Mukesh Singhal

Dr. Rakesh L. Shrivastava

Dr. Balkrishna Narkhede

Kranti P. Dharkar


viii


ix

ACKNOWLEDGEMENT

Writing the book on ISO 9001:2015 QMS with interpretations and case examples is an

uphill task. However, the same has become easier with the support received from the

members of Shreyas Quality Management System and also the organizations associated

with it. As a principle author I would like to thank my co-authors for their active

participation in making this book in its present form within defined time period. The team

of authors has provided the inputs based on their diverse experience, knowledge and

skills, which has made this book useful to the readers. I also thank the publisher of the

book for accepting the book for publication and also bringing it out in the shortest time.

We, authors , are thankful to our family members for bearing with us and providing us

the inspiration and motivation in completing this book. Last and not the least we are

thankful to all those who have helped directly or indirectly in development of this book.


x

DEDICATION

________________________________________________________________________

The book is dedicated to Smt. Suman Ram Lakhe and Late Dr. Ram K Lakhe who

practiced the principles of Quality Management System in their personal life.


xi

CONTENT LIST

Sr.no. Content Page

no.

1. Chapter 1-Introduction to ISO 9001 Quality Management

System

1

Clause

no.

Title

1.0 Chapter objectives 2

1.1 Introduction to ISO 2

1.1.1 Different ISO standards 4

1.2 ISO 9001 origin, evolution & benefits 4

1.2.1 ISO 9000 series 5

1.2.2 First revision in 1994 6

1.2.3 Second revision in 2000 7

1.2.4 ISO 9001:2008 QMS Requirements 8

1.2.5 ISO 9000:2015 family 8

1.2.6 ISO 9001 Changes 9

1.2.7 Purpose of quality management system 10

1.2.8 Benefits of quality management system 10

1.2.9 Risk based thinking 11

1.3 Seven principles of ISO 12

1.3.1 Customer focus 13

1.3.2 Leadership 14

1.3.3 Engagement of people 16

1.3.4 Process approach 17

1.3.5 Improvement 19

1.3.6 Evidence/fact based decision making 20

1.3.7 Relationship management 22

1.4 ISO 9001:2015 23


xii

1.5 ISO 9001:2015 standard requirements 23

1.6 Achieving ISO 9001 certification 26

1.7 Case study- fast logistics-need for ISO 9001-2015 30

1.8 Learning assessment 32

2. Chapter 2- Clause 4: Context of organization 34


2.1 Introduction to context of the organization 34

2.2 Block diagram for Clause 35

2.3 Terms used in Clause 36

2.4 Understanding the organisation and its context

(Clause 4.1)

36

2.4.1 Clause requirements 37

2.4.2 Block diagram 38

2.4.3 Linkages to other Clauses 38

2.4.4 Input-Process-Output for contextual issues 38

2.4.5 Intent of the Clause 39

2.4.5.1 Interpreting the context of organization 39

2.4.5.2 External issues 41

2.4.5.3 Internal issues 43

2.4.6 Tools used for contextual issue identification 44

2.4.6.1 SWOT analysis 44

2.4.6.1.1 SWOT process 45

2.4.6.1.2 Benefits of SWOT 46

2.4.6.1.3 Case example 46

2.4.6.2 PESTEL analysis 52

2.4.6.2.1 PESTEL process 54

2.4.6.2.2 Advantages and disadvantages of a PESTEL

analysis

54

2.4.7 Implementation guidelines 55

2.4.8 Plan- Do-Check-Act for contextual issues 56

2.4.9 Demonstrating compliance 57

2.4.10 Audit questions 58


xiii

2.5 Understanding the needs and expectations of

interested parties (Clause 4.2)

59

2.5.1 Clause requirement 59

2.5.2 Block diagram of interested parties 60


2.5.4 Input-Process-Output for interested parties 61

2.5.5 Intent of the element 61


2.5.7 Plan-Do-Check-Act for gathering the needs and

expectation of interested parties

64


2.5.9 Auditor‘s question 69

2.6 Determining the scope of quality management

system (Clause 4.3)

69

2.6.1 Block diagram of scope of QMS 70

2.6.2 Linkage to other Clauses 70

2.6.3 Input-Process-Output for scope of quality

management system

70



2.6.6 Plan-Do-Check-Act for scope of quality

management system

73


2.6.8 Auditors question 75

2.7 Quality management system and its processes

(Clause 4.4)

75

2.7.1 Clause requirements 76

2.7.2 Block diagram of QMS and its processes 77


2.7.4 What is meant by process? 77

2.7.5 Input-Process-Output for quality management

system and its process

78


2.7.7 Implementation guidelines: 79


xiv

2.7.8 Plan-Do-Check-Act for QMS and its processes 80

2.7.9 Demonstrating the compliance 81

2.8 Audit questions 85


3. Chapter 3- Clause 5: Leadership 93


3.1 Introduction to leadership 93

3.2 Block diagram of leadership 94

3.3 Linkages to other Clauses 95

3.4 Terms and definitions used in Clause 95

3.5 Leadership and commitment (Clause 5.1/5.1.1) 96


3.5.2 Block diagram 97




3.5.6 Plan-Do-Check-Act for leadership 100


3.6 Customer focus (Clause 5.1.2) 102


3.6.2 Block diagram of customer focus 102


3.6.4 Who is customer? 103

3.6.5 Input-Process-Output for customer focus 104




3.6.9 Plan-Do-Check-Act for customer focus 108

3.7 Quality policy (Clause 5.2) 109


3.7.2 Block diagram of requirements of quality policy 110



xv

3.7.4 Input-Process-Output for quality policy 110



3.7.7 Plan-Do-Check-Act for quality policy 113

3.7.8 Clause requirements overview through W-H

questions

114


3.7.10 Auditing perspective 116

3.8 Organizational roles and responsibilities (Clause

5.3)

117


3.8.2 Block diagram of requirements of roles,

responsibility and authority

117


3.8.4 Input-Process-Output for roles, responsibility and

authority

118


3.8.6 Implementation guidelines: 119

3.8.7 Plan-Do-Check- Act for roles, responsibility and

authority

120

3.8.8 Clause requirements overview through W-H

questions

121


3.9 Auditor questions 126


4. Chapter 4- Clause 6: Planning 131


4.1 Introduction to planning 131

4.2 Block diagram for planning 131

4.3 Terms used in Clause 133

4.4 Actions for addressing the risk and opportunity

(Clause 6.1)

133



Get Complete Book

At Educreation Store

www.educreation.in


Sample Copy. Not For Distribution.1.5 ISO 9001:2015 standard requirements 23 1.6 Achieving ISO 9001...

Documents

Transcript of Sample Copy. Not For Distribution.1.5 ISO 9001:2015 standard requirements 23 1.6 Achieving ISO 9001...