EN 9100:2018 – Basics of the aerospace standard

In order to be certified according to EN 9100, it is not primarily decisive how high the proportion of operational value added is in aerospace or defense. The important factor, however, is that the business focuses on development, manufacturing and/or service provision. If it is a maintenance-focused operation or a distributor, certification to the other two aviation standards, i.e. EN 9110:2018 for maintenance organisations or EN 9120:2018 for distributors, is more likely to be considered. EN 9110 tends to include more requirements, EN 9120 fewer, than the EN 9100 aviation base standard.

The aerospace standard is available as the EN 9100:2018. This editions is identical and therefore equivalent to the American AS 9100 of the Society of Automotive Engineers (SAE) and the JISQ 9100 of the Japanese Aerospace Quality Group. As of 2018, there are approximately 6500 operating sites in Europe with EN 9100:2018 certification, and nearly 20,000 worldwide.

The basis of EN 9100:2018 is the ISO 9001:2015. In this respect, the aerospace standard is not only based on the so-called High Level Structure, i.e. the uniform structure of ISO management system standards. EN 9100 contains all the requirements of ISO 9001, it even includes them. Therefore, the aviation standard also aims at an efficient QM system. This must be aligned across all core processes, i.e. not just audit and monitoring activities. The standard covers all processes, hierarchies and phases of service delivery, which is done systematically according to the Plan-Do-Check-Act (PDCA) cycle. The main requirements of ISO 9001 therefore apply to the following areas:

• Knowledge of internal and external operational influencers and interested parties,
• Establish and maintain a process-oriented quality management system, including knowledge and management of operational risks and opportunities,
• Management’s responsibility and authorisations
• Determination of quality policy and objectives with consideration of customer satisfaction
• Staff qualification, operational knowledge, awareness including the definition of responsibilities and authorities.
• Systematic planning and management of service delivery, taking into account resources and requirements for documented information,
• Systematic collection and integration of customer requirements,
• Planning and execution of design work and product or service development,
• Select, monitor and manage external vendors and evaluate and audit supplied products and services,
• Planning and execution of service provision including its release and post-delivery activities,
• Process and product monitoring and measurement, and analysis of collected data,
• Measures of error correction and risk minimization as well as continuous improvement

As described above, EN 9100:2018 fully incorporates ISO 9001:2015. The supplementary aerospace industry requirements are printed in bold italics in the norm text, so that they stand out clearly from the ISO 9001 components. Major additions to EN 9100:2018 compared to ISO 9001:2015 are, for example, requirements for:

• Configuration Management,
• product safety and to the handling of counterfeit parts,
• the validation of special processes and to critical units,
• operational risk management,
• the development requirements that go well beyond the ISO 9001 specifications, especially in the area of verification and validation,
• the document and evidence management,
• the identification and traceability,
• supplier monitoring and supplier communication,
• the process and customer satisfaction measurement as well as the tracking of target achievement via the so-called PEAR forms.

The aviation-specific extensions bring the EN closer to EASA’s aviation regulations (particularly the Implementing Rules to Part 21 and Part 145), although one clearly difference remains. While the EN 9100 standards focus primarily on customer satisfaction and process orientation, the EASA regulations keeps the eye only towards flight and product safety.

In terms of content, EN 9100 / AS 9100 remains predominantly unspecific. System standards define what has to be implemented in the end, but not how processes and work steps have to be designed in detail. No tools, instruments or implementation methods are specified, only output requirements. Management system standards leave the detailed content of the process design, i.e. the choice of means, to the companies.

As a newcomer to the industry, it is costly to obtain certification without expert assistance. Not only is there often a lack of aviation industry expertise, there is also a lack of know-how for the interpretation and operational implementation of the standards requirements. It is also difficult to deal with the specifications for process measurement in the course of the Process Effectiveness Assessment Reports (PEAR), which are not described in EN 9100:2018, but only in EN 9101. Last but not least, companies seeking certification in aerospace and defense must learn to assess the certification auditor’s way of thinking and testing on their own, without external support. However, this experience is only gained during the audit, so that many deficiencies often have to be eliminated within a short period of time. Due to the numerous industry and standard specifics, it is almost essential for companies wishing to be newly certified to an aviation standard to engage the services of a consultant with aviation experience.

In the aerospace industry, certification to one of the standards from the EN 9100 series is mandatory for establishing supplier relationships. The aerospace standard are not only highly attractive for the major players in the industry, i.e. primarily the Airbus and its 1-tier suppliers, i.e. the direct suppliers. But this also applies for companies with EASA approvals.

In case of a certification acc. to EN 9100, EN 9110 or EN 9120, these companies demonstrate the quality capability of their suppliers to their aviation authority or their own customers on the basis of a uniform QM system. At the same time, the companies can reduce their expenses, especially for on-site monitoring in the form of supplier audits. For them, this results in the advantage of partially outsourcing their supplier monitoring. The EN certificate serves as an important proof of the supplier’s own quality capability to customers.

Information on the certification audit process is presented separately in this article.