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Name of the Book :
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Powerful Processes of ISO 9001:2015 for Manufacturing Organizations
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Edition :
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First Edition ; Jan 2020
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Name of the Author :
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Giridhara Sanjeevi
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Name of the Publisher :
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Qualitybooks
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Number of pages :
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149
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Scope :
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Applicable for Manufacturing Organizations
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Related topic/Field :
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Quality Management System, Process Management, Quality Management, Industrial Engineering, Total Quality Management, Business Management, Strategic Management, Quality, Quality Control/Quality Assurance and International Standard.
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ⓒ Copyright Reserved :
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ⓒ copyright reserved to Publisher. All rights reserved. No part of this material or book may be reproduced, copied, edited, transmitted and published in any form without written permission from the publisher.
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ASIN
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B084FHKVM6
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ISBN
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978-81-945237-0-3
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Disclaimer :
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Qualitybooks has exercised due care in providing all the information before publishing this book. In spite of this, any omission, inaccuracy of information or printing error occurs with regards to the information contained in this book, Qualitybooks will not be held responsible or liable. Qualitybooks encourages readers to give feedback about this book. Qualitybooks is committed to improving this book, based on the feedback received from the readers. Readers may give feedback about this book in the below email id.
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Contact Details :
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Qualitybooks
No-5, Kutralam Nagar,
Kovaipudur, coimbatore 641042
Mobile : +919442248124
Web link: https://www.isoconsultantsincoimbatore.com
Email id : 607014@gmail.com
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Preface-About the Book
This book is useful to…
· gain an advanced knowledge of the organizational processes
· understand the requirements of ISO 9001:2015 and processes of QMS
· understand how to integrate the organizational processes into QMS
· understand, control, practice and enhance the organizational processes
· drive processes to achieve the organizational performance/goals/success
· manage the processes during the transformation/changes in the manufacturing processes/product/system/organization
· train the employees in QMS processes
This book is useful to understand and implement the best and powerful processes in the manufacturing industries. The processes addressed in this book are useful to implement ISO 9001:2015 Quality Management System (QMS) more effectively and to obtain expected performance results from the Quality Management System.
This book can be used as a reference book in a manufacturing organization to effectively implement a quality management system (QMS).
This book is useful to…
· any top management officials(Example: President, Managing Director)
· managers/supervisor/engineers/head of the department/in-charges/any staff/employee/process owners
· management representatives/ISO coordinators/system coordinators/quality system team members
· quality consultants/coaches/management professionals/consultants
· certification body auditors
· students/management scholars/faculties
· anyone who is interested in QMS/improving the organizational processes.
Powerful Quality Management or ISO 9001 processes practiced by the successful organizations, practical experiences, case studies and model formats are addressed at PART B of this book.
Model formats given in this book are not standard formats. Users can modify these formats to suit their needs or the organizational processes.
Throughout this book, “QMS” means “Quality Management System” and “Organization” means the organization implementing QMS.
This book is not an ISO 9001 standard. This book does not contain ISO 9001:2015 standard’s requirements. The reader may refer ISO 9001:2015 standard to know such requirements. More information about the publication of the ISO 9001 standard is given in Part C of this book.
About the Author
Giridhara Sanjeevi
The author is a graduated mechanical engineer. He is a senior consultant in management systems with 26 years of professional experience. The author has provided consultancy for clients for achieving various Management System Certifications. The author has conducted very extensive training programs to the client members towards understanding the standard’s requirements and implementing the related processes/practices.
The author has implemented various management system standards like ISO 9001, TS/IATF 16949, ISO 14001, BS 18001/ISO 45001, ISO 13485, AS9100, ISO 17025 and ISO 22000 at manufacturing, software and service verticals about 300+ clients.
The author has provided awareness trainings and implementation trainings in these standards.
The author has provided Internal Auditor Trainings for ISO 9001, TS/IATF 16949, ISO 14001, ISO 45001 standards and certified about 650 participants.
Author has the following competencies or certifications…
· Qualified Lead Auditor-ISO 9001:2015,
· Qualified Internal Auditor-IMS (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 standards)
· Qualified Internal Auditor-IATF 16949:2016
· Qualified Six Sigma Black Belt
· Qualified CMMI-DEV 1.3 CMMI-Development (SEI authorized).
Contact details
Author: Giridhara Sanjeevi
Mobile : +919442248124
Email : 607014@gmail.com
Contents
PART A: Introduction 7
1.
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History of publication of ISO 9001
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8
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2.
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Importance of QMS in the manufacturing sector
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9
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3.
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Understanding “Quality”
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10
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4.
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History of Quality
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12
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5.
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Understanding the Quality Management System (QMS)
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13
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6.
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Benefits of QMS/ISO 9001
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16
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7.
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Limitations of ISO 9001
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16
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8.
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Indicators of the absence of system (QMS)
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17
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9.
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Indicators of the presence of system (QMS)
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17
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10.
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Understanding the concept “process”
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18
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11.
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Difference between activity and process
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21
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12.
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Difference between process and function
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21
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13.
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Difference between process and system
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21
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14.
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Quality Management principles
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22
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15.
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Plan, Do, Check & Act cycle (PDCA)
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23
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PART B: Practice Powerful processes of ISO 9001:2015 for Manufacturing 24 Organizations
1
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Scope
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25
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2
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Normative references
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26
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3
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Terms and definitions
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26
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4
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Context of the organization
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27
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4.1
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Understanding the organization and its context
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28
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4.2
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Understanding the needs and expectations of interested parties
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30
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4.3
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Determining the scope of the quality management system
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32
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4.4
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Quality management system and its processes
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34
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5
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Leadership
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37
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5.1
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Leadership and commitment
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38
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5.2
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Policy
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40
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5.3
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Organizational roles, responsibilities and authorities
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41
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6
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Planning
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43
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6.1
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Actions to address risks and opportunities
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44
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6.2
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Quality objectives and planning to achieve them
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51
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6.3
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Planning of changes
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54
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7
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Support
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55
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7.1
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Resources
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56
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7.1.1
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General
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56
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7.1.2
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People
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57
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7.1.3
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Infrastructure
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58
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7.1.4
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Environment for the operation of processes
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60
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7.1.5
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Monitoring and measuring resources
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61
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7.1.6
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Organizational knowledge
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64
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7.2
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Competence
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65
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7.3
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Awareness
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69
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7.4
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Communication
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71
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7.5
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Documented information
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73
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8
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Operation
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80
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8.1
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81
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8.2
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Requirements for products and services
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83
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8.2.1
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Customer communication
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83
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8.2.2
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Determining the requirements for products and services
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83
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8.2.3
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Review of the requirements for products and services
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84
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8.2.4
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Changes to requirements for products and services
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87
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8.3
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Design and development of products and services
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88
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8.3.1
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General
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88
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8.3.2
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Design and development planning
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90
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8.3.3
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Design and development inputs
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91
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8.3.4
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Design and development controls
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92
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8.3.5
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Design and development outputs
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96
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8.3.6
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Design and development changes
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97
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8.4
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Control of externally provided processes, products and services
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100
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8.5
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Production and service provision
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105
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8.5.1
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Control of production and service provision
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105
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8.5.2
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Identification and traceability
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107
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8.5.3
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Property belonging to customers or external providers
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109
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8.5.4
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Preservation
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110
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8.5.5
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Post-delivery activities
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111
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8.5.6
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Control of changes
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112
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8.6
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Release of products and services
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113
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8.7
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Control of nonconforming outputs
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115
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9
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Performance Evaluation
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118
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9.1
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Monitoring, measurement, analysis and evaluation
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119
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9.1.1
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General
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119
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9.1.2
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Customer satisfaction
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120
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9.1.3
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Analysis and evaluation
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122
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9.2
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Internal audit
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123
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9.3
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Management review
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126
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10
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Improvement
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130
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10.1
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General
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131
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10.2
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Nonconformity and corrective action
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132
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10.3
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Continual Improvement
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139
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PART C: How ISO 9001 Standard is published? 140
1
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Publication of ISO 9001
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141
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2
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Why are the standards revised?
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141
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3
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What is the certified organization expected to do when a standard is revised?
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141
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4
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Key changes in ISO 9001:2015
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141
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PART D: Certification Process 143
1
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Difference between accreditation and certification
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144
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2
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Certification body
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145
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3
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What are the types of certification body audits?
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145
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4
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What is “nonconformity” to the ISO 9001 requirement?
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147
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5
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How the nonconformities are classified in the certification audits?
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147
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6
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What are the impacts of nonconformities to the ISO 9001 requirements?
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147
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7
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How the ISO 9001 certificates issued to the organization?
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147
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8
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Implications of non conforming organizations
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148
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9
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What is the cost of certification?
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148
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10
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How to submit a new application for ISO 9001 certification?
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148
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11
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Validation period for an ISO 9001 certificate
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148
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References
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149
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PART A
Introduction
History of publication of ISO 9001
ISO 9001 preparation and publication activity is administered by the technical committee TC 176/Sub-committee SC2 of International Organization for standardization (ISO).
ISO 9001 published in the following years…
• 1987, 1st edition
• 1994, 2nd edition
• 2000, 3rd edition
• 2008, 4th edition
• 2015, 5th edition
During 1st and 2nd edition, the title of the ISO 9001 was “Quality Assurance-Requirements”. There were three sets of standards published in the years 1987 and 1994, namely, ISO 9001 (manufacturing with design), ISO 9002 (manufacturing without design) and ISO 9003 (inspection and testing).
In the year 2000, the title of ISO 9001 was changed as “Quality Management Systems-Requirements”, ISO 9002 & 9003 standards were withdrawn, and ISO 9001 is commonly used for all types of the organization (with design or without design).
More information about the publication of ISO 9001 is given in the PART C.
Importance of QMS in the manufacturing sector
The organization has to satisfy its own purpose of existence. Sustaining in business, improved performance, fulfilling the organization responsibilities, an increase in turnover & profit and business growth are some examples for the purpose of its existence.
Manufacturing organizations are of two types…
1) The organization that designs & develops the product and then manufactures and supplies to the market
2) The organization that manufactures and supplies to the market as per the design specifications received from its customers
In both types, the following factors affect the organization’s performance…
· frequent changes in the customer requirements
· increase in manufacturing cost
· increase in cost of supporting activity (cost of the inspection, cost of administration, etc.)
· cost of poor quality problems/loss due to quality issues
· risks in products and operations that may create loss to business
· competitor’s performance
· loss of a customer
· incompetent employees
· poor administration and management of resources
· non-value-added activities
To manage these factors and to increase the organizational performance, Quality Management System (QMS) is an effective tool.
An organization implementing QMS effectively can realize the improved performance and can satisfy its purpose of existence.
Understanding “Quality”
Before understanding the “Quality Management System (QMS), the term “Quality” should be understood.
When ISO 9001:2015 standard talks about “quality”, it refers to the “quality of the product or service” provided by the organization. This scope is very clearly mentioned in the chapter 1 of ISO 9001:2015.
ISO 9000:2015 is most useful standard to understand the concept called “Quality”.
Quality is a characteristic. Both external (tangible) and internal (in-tangible) characteristics are the quality characteristics of a product or service.
Normally “product” can be seen physical form (visible or tangible) and “service” is a non-physical form (non-visible or intangible).
Characteristics like functional, physical, chemical, sensory, biological, safety, aesthetic, electrical, magnetic, ergonomic, etc., are the examples of quality characteristics of a “product”.
Characteristics like behavior, temporal (punctuality, honesty, respect), ergonomic, etc., are the examples of quality characteristics of a “service”.
Example of “quality characteristics” of a smart-phone…
· working without hanging/prolonged battery life/life of the phone
· speed/no heat
· music clarity/voice clarity/camera quality
· more features
· child-proof /shock-proof/radiation Proof
· data storage facility
· internet/social media/hot spot tethering
· information security and many others
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Quality characteristics are the inherent properties of a product/service to fulfill the “requirements”. Here the “requirements” include ‘safety to the users’, ‘legal requirements’, ‘functional requirements’, ‘intended purpose’ and ‘customer expectations’, etc. Inherent means, characteristic which “exists” in the product/service.
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The organization has to identify the safety requirements applicable for the product/service supplied. Example; “Non-availability of sharp edges” is one of the safety requirements for many products. These requirements are given in the customer drawing or organization has to choose these requirements from the national or international standards.
The organization has to identify the legal requirements applicable for the product/service it supplies. Example; environmental emission norms prescribed by the regulatory body are to be identified and fulfilled by the car manufacturers.
Functional requirements may be applicable for the organizations providing product with design or with installation or post sales service activities (For example: Fuel economy of diesel generator-units of power generated Vs liters of diesel used).
The product has to fulfill the “Intended use”. Indented use varies vary product to product (For example: the characteristics for the cloth used for summer is different from the characteristics for the cloth used in winter). Fulfilling intended use is the quality requirement. The organization has to understand and fulfill the “intended use” requirements of the product/service it supplies.
Customer expectations are the Quality characteristics: Some of the expectations are expressed by the customer in the form of written communication (For example; drawing). Some of the expectations are communicated verbally (over phone/during personal interactions). Some of the expectations are untold by the customer, but if it is not taken care, then the organization has to face with quality problems (For example: type of packing to be done to prevent damage during the transit of the product). If product characteristic is not up to the expectations of a customer for the cost paid, and then the customer is dissatisfied with the product, thus the “Quality” of the product is graded by the customer as “poor”. If product characteristics are meeting the expectations for the cost paid, then the product is graded as “good” by the customer. If product characteristics go beyond the expectations of a customer for the cost paid, then the product is graded as “excellent” by the customer. This is applicable for service also.
In the organizations manufacturing products as per the customer’s drawing, the quality of the products is measured in terms of material properties, dimensions, visual aspects specified by the customer drawing. To test the material properties, testing equipment like a spectrometer is used. To measure the dimensional characteristics, measuring instrument like a micrometer or vernier is used. Visual aspects are checked through visual inspection. If the material properties, dimensional characteristics and visual aspects meet customer drawing requirements, then the product is accepted as a quality product by the customer during their inward inspection and is released to the further production line at customer end.
Definition for Quality (as per ISO 9000:2015):
Note 1: The term “quality” can be used with adjectives such as poor, good or excellent.
Note 2: “Inherent” means existing in the object.
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History of Quality
• 1800-1850: The Industrial Revolution caused the involvement of specialized laborers. This caused the introduction of the inspection process after the manufacturing process.
• 1924: Walter A Shewhart of bell laboratories (US) developed a statistical process control chart.
• 1947: ISO-International Organization for Standardization established to promote quality/standards.
• 1950: W.Edward Deming and Joseph M. Juran promoted quality in Japan
• 1960: Quality Circles were formed in Japan to improve quality
• 1967: US dept of defense developed MIL-Q 9858: Quality System Specification and MIL-I 45208: Inspection System Specification.
• 1970: UK BS 5750: Quality System Standard published by the British.
• 1980: TQM concepts were developed. SPC concepts were implemented in the automotive industries and their suppliers in the US.
• 1987: ISO published the first ISO 9001 standard.
The concept of “quality” evolved after the industrial revolution. The concept of quality has been understood in a much deep manner after the implementation of statistical process control tools after the1920s.
Understanding the Quality Management System (QMS)
The system means “assembly of interacting elements”
This concept can be explained through a simple system “pen”.
Elements or components of a ball pen…
· Barrel
· Spring
· Thrust device
· Thrust tube
· Plunge
· Refill (ballpoint tip with ink chamber)
Interactions in the “Pen” as a system
Elements are interconnected in this assembly that enables interaction. While pressing plunge, the interaction starts and refill ballpoint tip come outside and ready for writing. If press again, due to the interaction of spring, the tip goes inside the barrel. While writing, the ink flows from the refill, this is one interaction.
Purpose of existence of system “pen”
· The purpose of this pen is to “write” information.
· While writing, ink flow should be adequate and consistent and should not be abnormal or inconsistent
Similar to the above example, the quality management system (QMS) is also a system.
What is the Quality Management System (QMS)?
QMS has the following elements/components…
· customers
· regulatory bodies
· staff/employees
· suppliers/service providers/bankers
· top management members/directors/share holders
· society/public
· facilities (shop floor, machines, utilities, measuring equipments, computers communication systems, etc.,)
· departments/functions within the organization
· standards/Data/Information/Act/Rules/Regulations
· drawings/customer standards/specifications/customer manuals
· procedures, Work instructions, control plans, process standards, Operational control plans, policy documents, etc.
· practices/processes/activities within the organization that affect quality
· formats
· information/data,
· measurable Targets/objectives
· maintaining things in an orderly manner (example 5s) and
· other things that affect quality of the product/service
“ISO 9001:2015” and “Quality Management System (QMS)” are the same. ISO 9001:2015 is a number given to a standard. The title of this standard is “Quality Management Systems-Requirements”. If we implement ISO 9001:2015 requirements effectively, it means that we implement a Quality Management System (QMS) effectively.
QMS covers all the aspects (elements) of an organization that affect the quality of the product/service it supplies.
There are always an integration and interaction between these elements. This interaction is called, “Process” within the QMS.
Example of interaction: A purchase order is issued from the customer. This purchase order requirements are transferred to the production function for further execution. The transformation of purchase order requirements to production function is called “interaction”. This interaction is also called a “process”.
To limit the scope, in QMS, we bother the interactions that affect “quality” and not other aspects like interactions with the environment, interactions with human safety, etc. We can use separate ISO standards for these management systems. For environment management system (EMS) we can implement ISO 14001 and for human safety or occupational health and safety management system (OHSMS) we can implement ISO 45001.
If we understand the components of QMS and its interaction, we can easily understand the concept called “Process”. The process is a very critical/important aspect of QMS. Controlling the “process” is a critical factor to control the “quality” of product/service.
Definition of Quality Management System (QMS) as per ISO 9000:2015
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Benefits of QMS/ISO 9001
Without a customer, an organization does not exist. The output of any organization is the product/service which is offered to its customers. Even though the organization is not certified to ISO 9001 standard, an informal QMS exists in the organization. In these organizations, the interactions of processes may not be the same as per the ISO 9001 requirements, but the organization might have its own processes established by the organization. But ISO 9001:2015 is a common model for QMS, which is compiled by the ISO from the best practices followed by the successful companies. If an organization implements this ISO 9001:2015 standard, its own processes can be upgraded at par with internationally best processes and formal QMS is kept in practice.
To manage the business processes effectively and to provide a product/service meeting customer requirements, QMS of the organization has to be driven effectively. By considering this fact, from 1st Jan 1995, as per World Trade Agreement (WTO) - TBT(technical barriers to trade), the customer organizations around the globe are insisting their suppliers to comply with ISO 9001.
Limitations of QMS/ISO 9001
ISO 9001 certification is given to an organization and not for the product. ISO 9001 is not a product standard. CE marking is an example for product standard. CE marking can be marked on the product itself. “ISO 9001” logo should not be used on the product directly.
In practice, in manufacturing organizations, at present accounts/finance requirements are not covered under the QMS while implementing ISO 9001, as accounts/finance related process (For example: Taxation) is regulated through government acts. An organization can include accounts/finance in its QMS if it wishes. However, accounts/finance activity is not audited during the certification audit. In fact, if a financial organization is implementing the ISO 9001 standard, then the accounts/financial processes are included in the QMS.
Indicators of the absence of system (QMS)
• In-consistent performance
• Undefined, unplanned and uncontrolled activities
• Performance depends on the individual’s brilliance
• Close and tight supervision is required
• Work hard but negligible results
• Weak communication process among the employees/with customers
• Line rejections/reworks or line stoppages
• Everybody under pressure & arguments
• Demotivated members, fire fighting & Low job satisfaction
• Search everywhere for everything
• Delivery delays
• Customers frequent calls/pressure/complaints/customer returns
• No improvements/growth
• Losses (financial and non-financial)
Indicators of the presence of system (QMS)
• Business is done in a professional way
• Culture is built and implemented that ensure quality in all processes
• Processes are carried out under a controlled environment
• Customer satisfaction is ensured
• Systems and Procedures lead employees to execute work independently
• The system prevents defects from happening (eliminates risks)
• Responsibilities and authorities of employees are defined
• If defect occurs, correction/corrective action process is followed
• Quality problems are resolved without any delay
• Lesser supplier/in-house/customer end nonconformities
• Lower cost of poor quality
• High organizational performance
• Lesser losses and Improves profit
• A Place for everything and everything in its place (5s)
• Environment for learning and knowledge sharing
• An effective communication system (internal and external) is in place
• Continual improvement is visible
Understanding the concept “process”
Definition of “Process” as per ISO 9000:2015
“set of interrelated or interacting activities that use inputs to deliver an intended result”
Note 1: Whether the “intended result” of a process is called output, product or service depends on the context of the reference.
Note 2: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes.
Note 3: Two or more interrelated and interacting processes in series can also be referred to as a process.
Note 4: Processes in an organization are generally planned and carried out under controlled conditions to add value.
Note 5: A process where the conformity of the resulting output cannot be readily or economically validated is frequently referred to as a “special process”.
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As per note 3 of ISO 9000:2015, two or more interrelated and interacting processes in “series” can also be defined as “process”. Here is the difference between “Process” and “System”. If two or more interrelated and interacting process in “series” (or may not be in series also) is linked, then such linkage creates a system. When processes are linked and integrated it is called system or simply a “quality management system (QMS)”. This concept is presented by a flow chart below…
The process is a set of activities that uses inputs and delivers output (intended result). The outputs from one process are taken as input to the subsequent process. This is how interaction happens between the processes. Integrating (linking or networking) the different organizational processes to achieve business objectives can be called “system” or “QMS”. Integrating the organizational processes effectively can result in strong a network of processes. Every process within this network of process is a powerful process. The administration and control of processes under the network of processes can result in the achievement of the organizational goals. If these processes are not controlled properly, it may result in losses and negative performance to the organization. These processes are established and practiced in accordance QMS requirements. Sections 4 to 10 of PART B of this book cover the powerful processes practiced by the successful organizations.
Processes will vary organization to organization. Processes depend on the product/service provided. In some organizations, product design process may be applicable and in some organizations, it may not be applicable. In some organizations, post sales installation activity may be applicable and in some organizations, it may not be applicable. While implementing 4.4 of ISO 9001:2015, we have to determine the applicable processes of the organization based on the scope of the product/service of the organization, organizational needs and expectations.
Difference between activity and process
“Activity” is the sub-process within the overall process. For example, quote preparation is the sub-process within the marketing process. Referring to the international standard requirements is the sub-process within the product development process. Raw material receipt from stores is a sub-process within the production process.
Difference between process and function
For example, the marketing process is also called “marketing function” or “marketing department”. The production process is called a “production function” or “production department”. There are sub-processes within a function/process. Example: Marketing Process contains sub-processes like 1) Collecting customer requirements, 2) feasibility review 3) Quote Preparation, 4) Negotiation, etc. Sub-process is also called “activity”. Sub-processes within a process/function are also mapped and controlled as addressed in chapter 4.4 of PART B.
Difference between process and system
Process means a conversion of inputs into an output (intended results). But system means the Quality Management System (QMS). QMS includes all processes within the organization like Marketing, Development, Supply chain management, inventory management, production management, Quality Assurance, machine maintenance, internal auditing process, customer complaint handling process, human resource development process, the management review process, etc. Integrating (linking or networking) various processes of the organization are called “system” or QMS.
Quality Management principles
As per ISO 9000:2015, the quality management system covers 7 principals as follows…
Principle
No
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Principle Name
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Importance
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1
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Customer Focus
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The organization should focus customer needs and expectations to manage its QMS processes
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2
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Leadership
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The organization should manage its QMS processes through leaders/process owners in every process
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3
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Engagement of people
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The organization should involve the competent employees in the QMS processes with clear responsibility, authority and provide the necessary training for them.
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4
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Process approach
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Identify QMS processes and their objectives. Define every process clearly and manage a network of processes effectively to get desired results
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5
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Improvement
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Improvement is a key factor in QMS.
Improve the process/product/system to achieve the organization goal/success
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6
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Evidence-based decision making
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Before taking decisions/implementing actions/making any changes, the organization should review the facts, data and information. QMS process should cover how to collect, analyze and evaluate the data.
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7
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Relationship management
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The organization should manage the relationship with all interested parties. The organization should take care of need and expectations of all interested parties to enhance its relationship management. QMS should cover these needs and expectations and related risks.
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Plan-Do-Check-Act cycle (PDCA)
PDCA
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Meaning
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P-Plan
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Define what to do, how to do and what to check and set objectives
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D-Do
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Implement what is planned
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C-Check
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Review/verify/check whether results are meeting the objectives
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A-Act
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Improve the plan, do and check activities based on the lesson learned from the implementation of PDC activities
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We should apply this PDCA cycle/approach for QMS processes. Quality management processes in the organization are established (plan), implemented (do), monitored (check) and improved (act) as per the PDCA approach.
PDAC cycle is also called a "Deming Wheel" or "Deming Cycle" was developed by renowned management consultant Dr. William Edwards Deming in the 1950s. Deming himself called it the "Shewhart Cycle" as his model was based on an idea from his mentor, Walter Shewhart.
PART B
Powerful Processes of Quality Management Systems (QMS) or ISO 9001:2015 for
Manufacturing Organizations
1 Scope
Purpose (scope) of the ISO 9001 standard is given in this section.
In this section, scope of the standard ISO 9001 is addressed. Scope of the standard is given as “It specifies the requirements for QMS”. ISO 9001 standard can be used when an organization…
· needs to demonstrate itself and to the external agency like certification body or customer for its ability to consistently provide products and services meeting customer and applicable legal requirements.
· aims to further enhance/improve customer satisfaction
· aims to further improve its processes/system towards conformity to customer and legal requirements.
The requirements given in the ISO 9001 standard can be used by any type of the organization.
2 Normative references
Normative reference means, applicable valid standard linked to ISO 9001. Title of the ISO 9000:2015 is “Quality management systems-Fundamentals and Vocabulary”. ISO 9000:2015 may be referred, as a guideline standard, if any clarification is required in the ISO 9001 standard. For example, if we need to know what the definition for “Quality” is, we can refer ISO 9000:2015 for answer. The organization cannot get certification for ISO 9000:2015.
3 Terms and definitions
Terms and definitions given in the ISO 9000:2015 are applicable for ISO 9001 standard.
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Giridhara S
Gravity Standards
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email : 607014@gmail.com
email : 607014@gmail.com
