Guideline for EN 9100:2018 (An Introduction to the European Aerospace and Defence Standard) ||

The European Standard EN 9100 is the industry-specific norm of the aerospace and defence industry. For cooperation with an aerospace company, certification according to this standard is usually mandatory for suppliers. This book provides support in understanding and implementing the standard or when switching from ISO 9001:2015 to EN 9100:2018. After an introduction to the ISO 9001, the emphasis is placed on the core characteristics of EN 9100 and EN 9120. The book focuses primarily on the explanation and translation of the standards' text into the language of everyday business. The structure of the book strictly follows that of EN 9100:2018. Numerous practical examples facilitate the understanding and implementation in your own company. Where appropriate, special characteristics of the distributor standard EN 9120 are also discussed. Finally, the author describes the certification process in great detail. This includes the preparation, the selection of a certification auditor and a certification body as well as the execution of the audit including process measurements, the handling of nonconformities and the issuing of the certificate. Due to the high degree of congruence between the standards of the EN 9100 series, this book is also suitable as a guideline for the EN 9110 for maintenance organisations and the EN 9120 for distributors. The target group This textbook is aimed at employees working in the quality department of suppliers in the aerospace industry. The author Prof. Dr. Martin Hinsch is an accredited auditor for EN 9100 and CEO of the AeroImpulse GmbH Aerospace Consultancy. Hinsch holds a Professorship for Aviation Management at the IUBH - International University. Prior to his current position, he was employed for many years at Lufthansa Technik AG, last as Senior Consultant in the Middle East Preface Contents Abbreviations 1 Introduction to Standardisation and the QM System According to EN 9100 1.1 Fundamentals and History of ISO Management Systems 1.2 High-Level Structure 1.3 Fundamentals of the EN 9100 1.4 Fundamentals of EN 9210 Reference 2 Key Characteristics of EN 9100:2018 2.1 Process Orientation 2.2 Risk-Based Thinking and Risk Management 2.3 Customer Focus References 3 Wording and Terms Reference 4 Context of the Organisation 4.1 Understanding the Organisation and Its Context 4.2 Understanding the Needs and Expectations of Interested Parties 4.3 Determining the Scope of the Quality Management System 4.4 Quality Management System and Its Processes References 5 Leadership 5.1 Leadership and Commitment 5.1.1 General Information 5.1.2 Customer Focus 5.2 Quality Policy 5.3 Organisational Roles, Responsibilities and Authorities References 6 Planning 6.1 Actions to Address with Risks and Opportunities 6.2 Quality Objectives and Planning to Achieve Them 6.3 Planning of Changes References 7 Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the Operation of Processes 7.1.5 Monitoring and Measurement Resources 7.1.6 Knowledge of the Organisation 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.5.1 General 7.5.2 Creating and Updating 7.5.3 Control of Documented Information 7.5.3.1 Availability and Protection of Documented Information 7.5.3.2 Control of Documented Information After Publication References 8 Operation 8.1 Operational Planning and Control 8.1.1 Operational Risk Management 8.1.2 Configuration Management 8.1.3 Product Safety 8.1.4 Prevention of Counterfeit Parts 8.2 Requirements for Products and Services 8.2.1 Customer Communication 8.2.2 Determining the Requirements for Products and Services 8.2.3 Review of the Requirements of Products and Services 8.2.4 Changes to Requirements of Products and Services 8.3 Design and Development of Products and Services 8.3.1 General 8.3.2 Design and Development Planning 8.3.3 Design and Development Inputs 8.3.4 Design and Development Controls 8.3.4.1 Design Verification and Validation by Means of Tests 8.3.5 Design and Development Outputs 8.3.6 Design and Development Changes 8.4 Control of Externally Provided Processes, Products and Services 8.4.1 General 8.4.2 Type and Extent of Control 8.4.3 Information for External Providers 8.5 Production and Service Provision 8.5.1 Control of Production and Service Provision 8.5.1.1 Control of Production Equipment, Tools and Software Programs 8.5.1.2 Validation and Control of Special Processes 8.5.1.3 Verification of the Production Process 8.5.2 Identification and Traceability 8.5.3 Property Belonging to Customers or External Providers 8.5.4 Preservation 8.5.5 Post-Delivery Activities 8.5.6 Control of Changes 8.6 Release of Products and Services 8.7 Control of Nonconforming Outputs References 9 Performance Evaluation 9.1 Monitoring, Measurement, Analysis and Evaluation 9.1.1 General 9.1.2 Customer Satisfaction 9.1.3 Analysis and Evaluation 9.2 Internal Audit 9.3 Management Review References 10 Improvement 10.1 General 10.2 Nonconformity and Corrective Action 10.3 Continuous Improvement References 11 The Process of EN 9100 Certification 11.1 Preparation for the Initial Certification 11.2 Selection of an auditor and a certification body 11.3 Stage 1 Audit 11.4 Certification Audit (Stage 2) 11.5 Processing of Audit Findings 11.6 Surveillance and Re-Certification Audits References Index