1.) DEFINITION

This standard is used to establish, maintain, and continuously improve a quality management system for aerospace companies to ensure product safety, reliability and compliance with regulations and customer requirements.

EN 9100 is based on the structure of ISO 9001.
EN 9100 or other standards from this series (EN 9110 “Maintenance organizations”, EN 9120 “Dealers and stockists”) cover for the most part the requirements:

• EASA Part 21, Subparts G and J
• EASA Part 145
• EASA Part CAMO, and
• Others

The above requirements describe in detail the structure and content of specific quality management systems with a strong safety focus, while the primary goal of EN 9100 is to achieve an effective and efficient business organization with satisfied customers.

2.) WHY IS EN 9100 CERTIFICATION NEEDED?

EN 9100 certification can be an important requirement for suppliers to the aerospace industry, or who wish to become one, in order to be approved as a supplier in the aerospace industry.

3.) ADVANTAGES

The consistent focus of your company on the systematic and targeted fulfilment of the requirements of customers and aviation authorities through the implementation of a quality management system in accordance with EN 9100 demonstrably leads to a continuous improvement in performance in all company processes.

Advantages of a certified quality management system according to EN 9100 can be:

• Internationally recognized quality management standard
• Inclusion in the Online Aerospace Supplier Information System (OASIS) database
• objective and reliable evidence of the effectiveness and efficiency of their processes
• Risk management processes
• Continuous improvement of business processes (CIP)
• Efficient management of other integrated quality management systems e.g. according to EASA Part 21, EASA Part 145, EASA Part CAMO and others
• Creation of prerequisites and environment for the implementation of other quality management systems in the areas of environment and occupational health and safety
• Creation of prerequisites for the implementation of other customer requirements such as APQP (EN 9145)

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

To achieve certification and demonstrate conformance to the standard requirements, the quality management system must meet the following requirements:

• Procedure, or process for configuration or change management,
• Procedure or process for process control including special processes and PLM (Product Lifecycle Management),
• Procedure or process for supplier management (selection, qualification and monitoring),
• Procedure, resp. process for traceability of products and services (also at the supplier),
• Effective planning and project management incl. procedure or process for the release of defined phases or milestones of product realization (development, manufacturing and after sales),
• Procedure or process for product or service-related risk management (DFMEA, PFMEA and identification of critical parts and key characteristics),
• Procedure, or process for approval of process changes, process and product deviations (error correction actions), and process approvals (e.g., FAI – First Article Inspection),
• Procedure, or process for developing process and inspection documentation,
• Procedure, or process, for dealing effectively with customer requirements (Especially when several different customer requirements have to be considered in one process),
• Procedure, or process for determining process capability and measurement capability,
• Procedure, or process for personnel qualification,
• Documentation, record keeping and archiving of evidence,
• And others

5.) OUR SERVICES IN THE FIELD OF EN 9100

We support you in the establishment of quality management systems according to EN 9100, both in the introduction and in the continuous monitoring and further development of your quality management system.
Already in the planning phase we consider your individual requirements and the urgency of your certification.

5.1. CONSULTATION

With our experience from numerous certification projects, we analyse and evaluate your processes and procedures. We usually proceed in the following six steps:

a. Initial interview: In an initial meeting, we work with you to determine the objectives, scope (resources, duration, and costs), and opportunities and risks of the certification project that could have an impact on the project e.g.:

• Need for and depth of integration of existing EASA Part 21, Part 145, and Part CAMO approvals.
• Need for integration/consideration of additional customer requirements (e.g., NADCAP, APQP, and other standards, procedures, and specific standards)
• Maturity and experience of the organization

b. stocktaking: Initially at the start of the project we offer you a GAP analysis (actual state of the quality management system vs. requirements from EN 9100 and, if applicable, customer requirements).
The aim of the GAP analysis is to identify the weak points and to define work packages and tasks in the project for the introduction of EN 9100.
The GAP analysis can also be performed as part of a pre-audit.
In addition, a SWAT analysis (Strengths, Weaknesses, Opportunities and Threats) can be performed.

c. implementation: In cooperation with you, we develop and optimize your processes and procedures with regard to the fulfillment of the standard requirements. If necessary, we implement the required quality management documentation with you and support you in the implementation as required.

d. certification process: We are happy to support you in commissioning and coordinating with the certification bodies.
In preparation for the certification audit, we conduct the pre-audits of the quality management system according to EN 9100 as a practical test in advance. We are also happy to accompany your internal auditors.

e. maintenance of certification: after successful certification, we support our customers as coaches or internal auditors and offer all-round support in the practical implementation of EN 9100 and customer requirements.

5.2. PRODUCTS

• Generic quality management manual according to EN 9100 with procedures, if necessary taking into account other customer requirements
• Forms and checklists (depending on requirements and complexity)

Note: In principle, all documents can be adapted to the current situation.