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

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