1) WHY IS A DESIGN ORGANISATION REQUIRED?
Anyone who intends to design aviation products such as aircraft, engines, or propellers, modifications to existing products, and the associated parts and equipment—such as structural components, landing gear, avionics, or other components—or ETSO articles in accordance with applicable design standards (CS – Certification Specifications), requires an approval as a Design Organisation under (EU) 748/2012, Part 21, Subpart J (DOA).
This means that a legal entity or natural person (the applicant) must demonstrate compliance with all relevant certification specifications. These include, among others, the design standards for each aircraft category, environmental requirements, operational suitability data, and—where applicable—special conditions. Compliance must be demonstrated in accordance with the requirements of the relevant sections of EASA Part 21, Subpart J and further applicable Subparts such as A, B, D, E, K, P, and Q.
After approval has been granted, the following certificates may be issued as evidence of compliance with the certification specifications:
- Declaration of Compliance
- DDP (Declaration of Design and Performance) – only for ETSO articles
Proof of compliance must be provided in accordance with the approved procedures within the Design Management System (DMS).
The higher the complexity and/or novelty of a product—whether an aircraft, engine, or propeller—or a change to an already approved product, the higher the requirements for the Design Management System (DMS).
Note: Please be aware that a Design Organisation under alternative procedures (ADOA)—limited to restricted design activities—may meet simplified requirements in accordance with 21.A.14.
2.) OPTIONS TO MEET THE REQUIREMENTS OF PART 21 (DOA)
The following prerequisites can be fulfilled to demonstrate an organisation’s capability to obtain the desired approval for a specific design:
* For definitions see (EU) 748/2012 Article 1 ** For definitions see GM 21.A.112B *** Upon Agency agreement Quelle: EASA
3.) DESIGN MANAGEMENT SYSTEM (DMS)
The Design Management System (DMS) is a key system for controlling and monitoring designs and design changes for products and parts covered by the applicable approval terms.
A core element of the DMS is the Safety Management System (SMS). The aim of the SMS is to identify and assess hazards affecting the product, its changes, or the design organisation with regard to flight safety, manage the associated risks, implement appropriate risk mitigation measures, and continuously verify their effectiveness.
In short: The established technical, organisational, and personnel requirements must fully cover the requirements of EASA Part 21, Subpart J.
In addition, the DMS must also control all external organisations—such as design subcontractors—involved in design activities.
The Design Management System is based on two key pillars:
- Design-related: Conducting an independent design review according to the “four-eyes principle” by a Compliance Verification Engineer (CVE)
- DMS-related: Implementing an Independent System Monitoring (ISM) function to continuously monitor and assess the overall system
4.) THE PATH TO BECOMING AN APPROVED DESIGN ORGANIZATION (DOA)
To establish a Design Organisation (DO) under EASA Part 21, Subpart J, the following prerequisites must be fulfilled:
- Providing the technical, organisational, and personnel requirements in accordance with EASA Part 21, Subpart J
- Preparing a Design Organisation Handbook (DOH) describing the Design Management System (DMS) and taking into account the relevant requirements of EASA Part 21, including Sections J, A, B, D, E, K, P, and Q
- Preparing a Flight Test Operations Manual (FTOM) – only required for design organisations developing new products or modifying existing products where flight testing is necessary
5.) ACC SERVICES IN THE AREA OF PART 21, SECTION J (DOA)
We support our customers in establishing design organisations in accordance with EASA Part 21, Subpart J and in obtaining approval as a Design Organisation (DOA). Our service portfolio includes, among others:
- Development or provision of high-quality Design Organisation Handbooks (DOH), individually tailored to your organisation and the type of design activities performed
- Preparation or provision of high-quality Flight Test Operations Manuals (FTOM)
- Training and coaching of your personnel regarding relevant processes, requirements, and standards
- Gap analysis: Comparison of the implemented design system against the requirements of EASA Part 21, especially Sections J, A, B, D, E, K, P, and Q
- Conducting internal audits, including pre-approval audits prior to official EASA approval audits in Phase 3 (before the third checkpoint)
- Interim management for the Independent System Monitoring (ISM) function
- Support during EASA audits and meetings—from preparation and execution through to follow-up activities