Implement AS 9100 D/EN 9100:2018 for business excellence : quality management systems -- requirements for aviation, space and defence organizations (same as EN 9100:2016; includes ISO 9001:2015) /
This 2024 updated and revised edition of "Implement AS 9100D/EN9100:2018 for Business Excellence" is an essential guide to mastering the latest Quality Management System requirements for aviation, space, and defence. The author brings over 45 years of expertise, blending theoretical knowle...
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| Format: | eBook |
| Language: | English |
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[United States] :
River Publishers,
[2025]
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| Series: | River Publishers series in transport technology.
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Table of Contents:
- Foreword xi Preface xiii Acknowledgements xv About the Book xvii List of Figures and Table xix List of Abbreviations xxi Introduction 1 0.1 General Comments 1 0.2 Quality Management Principles 8 0.3 Process Approach and QMS 10 0.3.1 General 11 0.3.2 Plan-Do-Check-Act cycle 14 0.3.3 Risk-based thinking 25 1 Scope of the Standard 31 2 Normative Reference 33 3 Terms and Definitions 35 4 Context of the Organisation 49 4.1 Understanding the Organisation and Its Context 49 4.1.1 Understanding the needs and expectations of the interested parties 50 4.1.2 Understanding the requirements and implementation 53 4.1.3 Understanding the organisation and its context 54 4.1.4 Needs and expectations of interested parties 56 4.2 Determining the Scope of the Quality Management System 59 4.3 Quality Management System and Its Processes 65 4.3.1 Process elements 65 4.3.2 Process flow and execution 68 5 Leadership 75 5.1 Leadership and Commitment 75 5.1.1 General 75 5.1.2 Customer focus 81 5.2 Policy 85 5.2.1 Establishing the quality policy 85 5.2.2 Communicating the quality policy 86 5.3 Organisational Roles, Responsibilities and Authorities 87 6 Planning 93 6.1 Actions to Address Risks and Opportunities 93 6.1.1 Organisational risks 94 6.1.2 Risk identification and assessment 97 6.2 Quality Objectives and Planning to Achieve Them 102 6.2.1 Measurable objectives 102 6.2.2 How to measure 104 6.3 Planning of Changes 108 7 Support 109 7.1 Resources 109 7.1.1 General 109 7.1.2 People 111 7.1.3 Infrastructure 112 7.1.4 Environment for the operation of processes 115 7.1.5 Monitoring and measuring resources 119 7.1.6 Organisational knowledge 125 7.2 Competence 130 7.3 Awareness 137 7.4 Communication 139 7.5 Documented Information 142 7.5.1 General 142 7.5.2 Creating and updating 146 7.5.3 Control of documented information 147 8 Operations 157 8.1 Operational Planning and Control 157 8.1.1 Operational risk management 182 8.1.2 Configuration management 189 8.1.3 Product safety 194 8.1.4 Prevention of counterfeit parts 204 8.2 Requirements for Products and Services 209 8.2.1 Customer communication 209 8.2.2 Determining the requirements for products and services 213 8.2.3 Review of the requirements for products and services 222 8.2.4 Changes to requirements for products and services 231 8.3 Design and Development of Products and Services 231 8.3.1 General 231 8.3.2 Design and development planning 232 8.3.3 Design and development inputs 241 8.3.4 Design and development controls 243 8.3.5 Design and development outputs 252 8.3.6 Design and development changes 257 8.4 Control of Externally Provided Processes, Products and Services 259 8.4.1 General 259 8.4.2 Type and extent of control 268 8.4.3 Information for external providers 272 8.5 Production and Service Provision 276 8.5.1 Control of production and service provision 276 8.5.2 Identification and traceability 300 8.5.3 Property belonging to customers or external providers 305 8.5.4 Preservation 307 8.5.5 Post-delivery activities 312 8.5.6 Control of changes 315 8.6 Release of Products and Services 319 8.7 Control of Nonconforming Outputs 325 8.7.1 Non-conformity 325 8.7.2 Non-conformity report (NCR) format 338 9 Performance Evaluation 341 9.1 Monitoring, Measurement, Analysis and Evaluation 341 9.1.1 General 341 9.1.2 Customer satisfaction 342 9.1.3 Analysis and evaluation 345 9.2 Internal Audit 351 9.2.1 Introduction to audits 351 9.2.2 Internal audits using criteria 352 9.3 Management Review 355 9.3.1 General 355 9.3.2 Management review inputs 356 9.3.3 Management review outputs 360 10 Improvement 363 10.1 General 363 10.2 Nonconformity and Corrective Action 366 10.2.1 Nonconformity 366 10.2.2 Nonconformity report (NCR) 370 10.3 Continual Improvement 371 11 Auditing 379 11.1 Type of Audits and Principles 386 11.2 Audit Methodologies 389 11.2.1 Certification audit process 392 11.3 Internal Audits Using 9100 Series Standards as the Criteria 401 11.4 Audit Planning 403 Annexure A: Bibliography 415 Annexure B: IAQG Aviation, Space and Defence Standards 417 Annexure C: Documented Information 419 Annexure D: Positive Recall Procedure 429 Annexure E: Nonconformity Report (NCR) Process Example 431 Annexure F: Management Review Agenda/Minutes (Example) 433 Annexure G: AS9104/1A Audit duration calculation (Consistent with IAF MD 5) is available in the TABLE 2 ⁰́₃ AUDIT DURATION REQUIREMENTS vide SAE standard AS 9104/1 (page 23 of 49) 436 Annexure H: Risk Register (Example) 439 Annexure I: Contract Review Checklist (Example) 448 Annexure J: Configuration Management Audit Checklist (Example) 457 Annexure K: Planning for Changes/Change Management Form 458 Annexure L: Test Your Knowledge 459 Answers 467 Index 469 About the Author 475.