1.) DEFINITION

The EN 9100 standard is designed to establish, maintain, and continuously improve a Quality Management System (QMS) for companies in the aviation and aerospace industry. Its purpose is to ensure product safety, reliability, and compliance with legal requirements as well as individual customer requirements.

EN 9100 is based on the structure of ISO 9001 and is part of a family of standards that also includes EN 9110(“maintenance organisations”) and EN 9120 (“distributors and stockists”). These standards largely cover the requirements of:

• EASA Part 21, Subparts G and J
• EASA Part 145
• EASA Part-CAMO
• and other relevant regulations

The above requirements describe in detail the structure and content of specific quality management systems with a strong focus on safety. However, the main objective of EN 9100 is to create an effective and efficient organisation that ensures a high level of customer satisfaction.

2.) WHY IS EN 9100 CERTIFICATION NEEDED?

EN 9100 certification can be a key prerequisite for current or future suppliers in the aviation and aerospace industry in order to be recognised as an approved supplier in the aviation sector.

3.) ADVANTAGES

Consistently aligning your organisation with the systematic and targeted fulfilment of customer and aviation authority requirements by implementing a QMS in accordance with EN 9100 has been proven to lead to continuous performance improvement across all business processes.

A certified quality management system according to EN 9100 offers numerous benefits for aviation and aerospace companies, including:

• An internationally recognised quality management standard for the aviation and aerospace industry
• Inclusion in the OASIS database (Online Aerospace Supplier Information System), increasing visibility as a qualified supplier
• Establishment of structured risk management processes to increase safety and efficiency
• Continuous improvement of all business processes in the spirit of continuous improvement (CIP / Kaizen)
• Efficient management of integrated quality management systems, e.g. in accordance with EASA Part 21, EASA Part 145, EASA Part-CAMO, and other relevant standards
• Creating the prerequisites and environment for implementing additional management systems in the areas of environmental protection and occupational health & safety
• Fulfilment of specific customer requirements, for example through the implementation of APQP (Advanced Product Quality Planning) in accordance with EN 9145

4.) THE WAY TO CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM ACCORDING TO EN 9100

To achieve EN 9100 certification and demonstrate compliance with the standard requirements, the QMS must meet the following requirements:

• Procedures/processes for configuration and change management
• Procedures/processes for process control, including specific processes and Product Lifecycle Management (PLM)
• Procedures/processes for supplier management, including supplier selection, qualification, and monitoring
• Procedures/processes for traceability of products and services, including for external suppliers
• Effective planning and professional project management, including procedures/processes for the approval of defined phases or milestones in product realisation (development, production, and after-sales)
• Procedures/processes for product- or service-related risk management, e.g. DFMEA, PFMEA, and the identification of critical parts and key characteristics
• Procedures/processes for approving process changes, deviations in processes and products (including corrective actions), and process release (e.g. FAI – First Article Inspection)
• Procedures/processes for developing process and inspection documentation
• Procedures/processes for efficient handling of customer requirements, especially when multiple customer-specific requirements must be considered within one process
• Procedures/processes for determining process capability and measurement system capability
• Procedures/processes for personnel qualification
• Documentation, compliance evidence, and archiving of all relevant records
• Additional standard-relevant requirements depending on the business area

5.) OUR SERVICES IN THE FIELD OF EN 9100

We support you in establishing and implementing EN 9100 quality management systems—both for initial implementation and for the continuous maintenance and further development of your existing QMS.

Already in the planning phase, we take your individual requirements and the urgency of your targeted certification into account.

5.1. CONSULTATION

With our extensive experience from numerous EN 9100 certification projects, we analyse and assess your existing processes and procedures precisely and purposefully. We typically follow these six work steps:

a) Initial consultation

During the initial consultation, we work with you to define the goals, project scope (including resources, duration, and costs), as well as the opportunities and potential risks of the EN 9100 certification project that may affect its progress. These include, for example:

• Necessity and depth of integration of existing approvals under EASA Part 21, Part 145, and Part-CAMO
• Integration of additional customer requirements and their implementation within the QMS, e.g. NADCAP, APQP, and other relevant standards, procedures, and specific requirements
• Maturity and experience of your organisation, especially with regard to existing processes, structures, and management systems

b) Current-state assessment

At the start of the project, we offer a gap analysis (current QMS status vs. EN 9100 requirements and, if applicable, customer requirements).
The objective of the gap analysis is to identify weaknesses and define work packages and tasks for the EN 9100 implementation project.

The gap analysis can also be performed as part of a pre-audit.

In addition, a SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) can be carried out.

c) Implementation

Together with you, we develop and optimise your processes and procedures to meet the standard requirements. Where necessary, we implement the required QMS documentation and support you in practical execution.

d) Certification process

We support you in selecting, commissioning, and coordinating certification bodies.
To prepare for the certification audit, we conduct EN 9100 pre-audits as a practical readiness test in advance—also as support for your internal auditors, if desired.

e) Maintaining certification

After successful certification, we continue supporting our customers as coaches or internal auditors and provide comprehensive assistance in the practical implementation of EN 9100 and customer requirements.

5.2. PRODUCTS

• Generic EN 9100 Quality Management Manual including procedures, if applicable considering additional customer requirements
• Forms and checklists (depending on needs and complexity)

Note: All documents can generally be adapted to the current situation at any time.