Author: © Tzvetelin Kirilov Gueorguiev
Reviewers:
Prof. Iliya Slavov Zhelezarov, PhD
Prof. Elka Slavcheva Vasileva, PhD
Scientific Editor:
Prof. Branko Dushkov Sotirov, PhD
Technical Editor:
Diana Todorova Gueorguieva
Publisher:
PRIMAX
ISBN: 978-619-7726-14-5
Prepress and Layout:
Tzvetelin Gueorguiev
Cover Artist and Title Page:
Diana Gueorguieva – Di-Light
Cover Design:
Martin Yordanov
Printing:
Academic Publishing House University of Ruse
2023
Firstly, I would like to thank my professor – Assoc. Prof. Tsvyatko Koriykov, PhD, who has instilled in me a love for quality, and kept this fire going until it became sufficiently strong to shed its proper light and overcome any challenge.
I thank Prof. Branko Sotirov, PhD for his professional advice and life wisdom, and for welcoming me to the team of metrologists at the University of Ruse. I also thank him for the detailed and constructive review of my monograph before it became a reality.
I am also thankful to my colleagues and industry partners, whose continued cooperation throughout the years has turned me into the person they see in me today.
Last but not least, I thank my family, who know my weaknesses, and in hard times support me and give me the energy to continue to work hard and enjoy my journey into the universe called QUALITY!
Competence and Creativity bring man closer to the divine 3
Acknowledgments 4
Foreword 7
Introduction 8
В.1. Personalities who laid the foundations of quality management 8
В.2. Chronology of quality management standards before ISO 9000 10
В.3. Quality management - in Bulgaria and abroad 12
В.4. Infrastructure for quality in Bulgaria 14
Conclusion 16
CHAPTER 1. BASES OF THE PDCA CYCLE 17
1.1. Management systems - modern standards 17
1.2. Quality management systems of the ISO 9000 series 19
1.3. Bases of the PDCA cycle in management systems 24
Conclusions from Chapter 1 33
CHAPTER 2. PLAN 35
2.1. Quality Management Principles 35
2.2. ISO 9001:2015 clauses related to stage "Plan" 38
2.2.1. Context of the organization (Clause 4 of ISO 9001:2015) 38
2.2.2. Leadership (Clause 5 of ISO 9001:2015) 57
2.2.3. Planning (Clause 6 of ISO 9001:2015) 63
2.3.Quality Planning Tools 68
Conclusions from Chapter 2 74
CHAPTER 3. DO 75
3.1. ISO 9001:2015 clauses related to stage "Do“ 75
3.1.1. Support (Clause 7 of ISO 9001:2015) 75
3.1.2. Operation (Clause 8 of ISO 9001:2015) 92
3.2. Quality Assurance Tools 111
Conclusions from Chapter 3 112
CHAPTER 4. CHECK 113
4.1. ISO 9001:2015 clauses related to stage "Check“ 113
4.1.1. Performance evaluation (Clause 9 of ISO 9001:2015) 113
4.2. Quality Control 125
4.3. Auditing management systems. The standard ISO 19011:2018 130
4.4. Quality Control Tools 134
Conclusions from Chapter 4 134
CHAPTER 5. ACT (IMPROVEMENT) 135
5.1. ISO 9001:2015 clauses related to stage "Act“ 135
5.1.1. Improvement (Clause 10 of ISO 9001:2015) 135
5.2. Quality Improvement Tools 141
5.3. Improvement and Innovations 142
5.4. Excellence Models 147
5.5. UN Sustainable Development Goals 151
5.6. Industry 4.0 and Quality 4.0 152
5.7. Supporting standards of the ISO 9000 series 154
5.8. Implementation of ISO 9001 in various sectors 155
Conclusions from Chapter 5 157
CHAPTER 6. AREAS OF REAL APPLICATION OF THE PDCA CYCLE 159
6.1. Education 159
6.2. Automotive Industry 161
6.2.1. IATF 16949:2016 161
6.2.2. Advanced Product Quality Planning (APQP) and Control Plan 161
6.2.3. Failure Mode and Effects Analysis (FMEA) 163
6.2.4. Measurement Systems Analysis (MSA) 164
6.2.5. Statistical Process Control (SPC) 165
6.2.6. Production Part Approval Process (PPAP) 166
6.2.7. Toyota A3 168
Conclusions from Chapter 6 169
Overall Conclusions 170
Contributions 171
Abbreviations 172
Abbreviations in Cyrillic alphabet 172
Abbreviations in Latin alphabet 172
Bibliography 176
About the author 185