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

© Springer-Verlag GmbH Germany, part of Springer Nature 2020

M. HinschGuideline for EN 9100:2018 https://doi.org/10.1007/978-3-662-61367-2_1

1. Introduction to Standardisation and the QM System According to EN 9100

Martin Hinsch¹  

(1)

Hamburg, Germany

Martin Hinsch

Email: [email protected]

1.1 Fundamentals and History of ISO Management Systems

Standardisation is a systematically initiated common harmonisation of processes, systems, terms or product characteristics for the benefit of a user group. The creation of standards is a uniform approach which, on one hand, introduces quality measures and thereby comparability. On the other hand, standardisation increases efficiency by eliminating uncertainties in planning as well as reducing technical and financial adjustments, thus simplifying the movement of goods and services.¹ For this purpose, the following types of standardisation are distinguished:

(a)

procedural standards (e.g. quality management according to ISO 9000),

(b)

technical standards (e.g. screw type, DIN A4) and

(c)

classification standards (e.g. country codes such as de, com, jp).

In order to develop their effectiveness, norms do not have to be formally and legally binding. The fact that most market participants follow a standard, also disciplines those who initially did not meet its requirements. Many standards exert (voluntary) pressure and thus have a stronger effect than laws: Whoever does not obey them will be punished by the market.

The first international standardisation efforts were already undertaken at the end of the nineteenth century/beginning of the twentieth century and had increased thereon rapidly. High growth took place especially after the Second World War with the foundation of the International Organisation for Standardisation (ISO), a sub-organisation of the UNO.

Until the nineteen seventies, the development and dissemination of technical standards dominated. It was not until 1979 that a standard for quality management systems was published for the first time. The ISO 9000 series of standards emerged from this in 1987. However, ISO 9001, as it is familiar to users today, only spread after the major revision of standard in 2000. Significant innovations were at that time a more comprehensible wording, more precise requirements and an improved applicability for service business. The strict process orientation is also attributable to this revision.

Today, the ISO 9000 series is regarded as the most important process-oriented standard worldwide. While ISO 9000 and ISO 9004 are explanatory and supportive, ISO 9001 is the only certifiable standard in this series. It is based on the idea that a QM system offers a transparent process for ensuring an appropriate quality level. The standard specifies minimum requirements that are independent of the specific service provision (product or service) and the size of the organisation in order to enable a uniform and comparable quality standard.

The certification according to the 9001 standard aims to,²

create and maintain sustainable competitiveness through an effective QM system with efficient processes and their constant evaluation.

constantly and systematically plan, implement, evaluate and improve the QM system.

reduce the amount by which certified companies repeatedly deal with their own errors, weak points and waste in resources in order to eliminate the causes sustainably.

The implementation of an efficient QM system is seen as an overall operational task, which must start with all core processes. The main requirements of ISO 9001 therefore apply to the following areas:

knowledge of internal and external issues as well as interested parties,

responsibility and commitment of the management regarding quality policy and objectives, including the definition of responsibilities and authorities,

establishment and maintenance of a process-oriented quality management system including knowledge and handling of operational risks,

personnel qualification, operational knowledge, awareness and provision of resources including the associated documentation,

recording and integration of customer requirements,

planning and execution of design and development (projects),

selection, monitoring and control of external suppliers as well as evaluation and inspection of delivered products and services,

planning and execution of the service provision including its release and post-delivery activities,

process and product monitoring and measurement as well as analysis of the collected data,

measures of corrective actions and risk minimisation as well as continuous improvement.

In terms of content, ISO 9001 (and thus also EN 9100) remains largely unspecific. Although system standards define what must be implemented in the end, they do not define how processes and tasks must be designed in detail. No tools, instruments or implementation methods are specified, only the requirements for outputs are defined. Quality management system standards leave the detailed process design, i.e. the choice of means, to the companies.

A QM system certification is accompanied by some disadvantages, as it is not the product or service quality that is checked, but the structure and organisation of processes of a company. This is often not sufficient to meet the wide range of quality requirements of many large multinational corporations, which therefore place their own requirements on their suppliers independently of standards. In addition, the quality requirements of ISO 9001 are not excessively high and thus even companies without a sustainable quality awareness can obtain the corresponding certificate.

1.2 High-Level Structure

All management system standards have a uniform design, the so-called high-level structure. This means that most chapters and top-level sections are identical to that of all important system standards. ISO 9001, EN 9100, IATF 16949 (Automotive), ISO 14001 (Environment), OHSAS 18001 (Occupational Safety) and ISO/IEC 27001 (Information Technology) as well as other standards have a common structure of their chapters in accordance with Fig. 1.1. This is reflected by the alignment of the contents of the standards with the terminology.

Fig. 1.1

High level structure for ISO management systems

The high-level structure makes it easier for companies and auditors to work with multiple certifications because it simplifies a consolidated presentation of their own quality management. Different standards can be linked to one and another within a company. They do not have to be dealt with individually. without following up on different standards simultaneously. However, there is no obligation for the companies to adapt the high-level structure for their own QM system if only the respective standard requirements are to be fulfilled.

1.3 Fundamentals of the EN 9100

Based on the ISO 9001, several industry-specific standards were developed at the end of the 1990s in which supplementary requirements of the respective industries were considered. In addition to EN 9100 for the aviation industry, ISO/TS 16949 for automotive engineering and TL 9000 for telecommunications have also emerged. These niche standards mostly arose from quality agreements that dominant market participants (e.g. Airbus, Boeing, Telekom and car manufacturers) demanded from their suppliers. The development was favoured by the fact that, based on such individual agreements, industry associations also issued quality standards in parallel or in addition to ISO 9001. Long before the first publication of EN 9100, the Airbus quality specifications in the 1990s had a decisive influence on quality standards published by national aviation associates in Europe. In addition, the publication of the American AS 9100, which is equivalent to EN 9100, had considerable influence on the publication of a separate aviation standard on a European level just before the end of the last millennium.³ As a direct consequence, EN 9100 was published in 2003 by the European Committee for Standardisation (CEN) as the first certifiable standard for aviation, space and defence organisations. In 2005, EN 9110 followed for maintenance companies and EN 9120 for distributors. In 2009/2010 and 2016/2017, all three aviation standards were again substantially revised.

The International Aerospace Quality Group (IAQG) and the European Aerospace Quality Group (EAQG) are in charge of the further development of the EN 9100 series and represent European interests through their support.

EN 9100:2018⁴ Contains the Complete ISO 9001:2015

The supplementary requirements of the aerospace industry in the 9100 standard text are shown in bold and italic letters and can thus be clearly distinguished from the classic ISO 9001 elements. Essential additions to EN 9100 compared to ISO 9001 are for instance:

configuration Management,

product safety requirements,

requirements for handling counterfeit parts,

the dedicated handling of special processes and critical items,

more detailed requirements for supplier monitoring and

further requirements for operational risk management,

higher requirements for verification and validation,

Process measurement and monitoring of the achievement of objectives via the so-called PEAR forms.

These extensions bring the EN closer to the EASA regulations (especially the Implementing Rules of Part 21 and 145), although considerable differences remain. While the EN focuses above all on customer satisfaction and process orientation, the EASA regulations focus on the safety aspect. In this respect, it is not surprising that both Airbus and the 1-tier suppliers, i.e. the Airbus’ direct first level suppliers, normally require their suppliers to provide proof of EN certification.

This constraint for certification means that the suppliers themselves are responsible for proving their quality capability. They must assign accredited certification bodies at regular intervals in order to have their own EN standard conformity checked and confirmed. The certification issued on this basis then serves as proof to the supplier’s customers. Thereby the OEMs themselves demonstrate the quality capability of their suppliers to their aviation authorities or their own customers. At the same time, customers can reduce their costs, especially for on-site monitoring through supplier audits. The advantage for the corporations is that they partially outsource their supplier monitoring.

Especially for suppliers of the lower levels of the supply cascade, certification does not necessarily imply additional cost. Many companies, especially the smaller ones, are for the first time systematically addressing the issues of quality management and process orientation as part of EN 9100 certification. The standard can therefore help to improve the operational value creation as well as interfaces to the customer. In this respect, certified companies often have a more pronounced process and quality awareness.

EN 9100 certification is also useful for those companies that are seeking approval under aviation legislation (production, maintenance, design). In this case, an accepted quality management system can be used which already adheres to the official requirements in many respects.

1.4 Fundamentals of EN 9210

In addition to the EN 9100, there is the EN 9120 for distributors in the aerospace and defence industry and the EN 9110 for aviation maintenance organisations. The EN 9110 will not be examined here as only approx. 250 companies, mainly corporate groups, are certified according to this standard in Europe.

A characteristic feature of the EN 9120 is its focus on the special requirements of the industry of distributers and stockholder. At the same time, EN 9120 does not contain all the requirements for production organisations. As of 2019, there are about 800 operating sites in Europe that are certified according to EN 9120:2018, and almost 2000 worldwide.

EN 9120:2018 also contains EN ISO 9001:2015 in its entirety. The supplementary requirements of the aerospace industry are shown in bold type and italics in the text of the standard and can thus be clearly distinguished from the classic ISO 9001 elements. Compared to the normal aviation standard EN 9100, EN 9120 mainly contains these supplementary requirements:

electronic documents and records proving origin (Sect. 7.5.3),

handling suspected unapproved parts (Sect. 8.1.5),

storage and delivery, especially for split products (Sect. 8.5.2),

dealing with nonconformities (Subsect. 8.7).

Compared to the reference EN 9100, the standard for distributors does not include requirements in the following areas:

parts of production planning and control (Subsects. 8.1 and 8.5),

risk management (Sect. 8.1.1),

product safety (Sect. 8.1.3),

validation of special processes (Sect. 8.5.1.2),

First Article Inspection (FAI) (Sect. 8.5.1.3),

usually also on design/development (Subsect. 8.3).

In order to be certified according to the distributor standard EN 9120, the share of the added operational value in aviation, aerospace or defence is not relevant. Instead, it is compulsory that the company to be certified has the characteristics of a distributor or stockholder and does not simultaneously carry out processing activities. While separating batches, cutting to size and preservation are permitted, even the smallest manufacturing activities (e.g. assembly) lead to an exclusion from EN 9120 and to a progression to EN 9100 or EN 9110.

The EN standard EN 9120 for distributors and stockholders can currently be certified in the Revision 2018. This is equivalent to the American AS 9120 and the Asian JISQ 9120.

In the following chapters, essential differences to EN 9100 are shown in the text, smaller differences in footnotes.

Reference

Hinsch, M.: Industrial Aviation Management: A Primer in European Design, Production and Maintenance Organisations. Heidelberg/Berlin (2019)

Footnotes

1

See Hinsch (2019) p. 36.

2

Since ISO 9001 is not only suitable for companies, but also for public authorities, associations and other institutions, to use the term organisation instead of company. According to the aviation standard, however, primarily private companies are certified, so that in the following text we will talk about companies.

3

As a result, the European Association of Aerospace Equipment Manufacturers (AECMA) was mandated by the European Committee for Standardisation (CEN) to develop European Standards (EN) for the aerospace industry.

4

In the following only briefly EN 9100.

© Springer-Verlag GmbH Germany, part of Springer Nature 2020

M. HinschGuideline for EN 9100:2018 https://doi.org/10.1007/978-3-662-61367-2_2

2. Key Characteristics of EN 9100:2018

Martin Hinsch¹  

(1)

Hamburg, Germany

Martin Hinsch

Email: [email protected]

2.1 Process Orientation

Since its major revision in 2000, ISO 9001 has followed the approach of process-oriented quality management, which was adopted by the EN 9100 with its publication in 2003. The corresponding requirements were tightened in its first revision in 2009 and again in 2015 with the publication of EN 9101:2018¹. The process orientation is therefore also reflected in the structure of the standard itself. For EN certification, an expanded understanding of process-based business organisation is therefore essential.

Process orientation is characterised by moving from a primarily department-orientation of service provision towards a procedural systematisation. The documentation of the processes makes an important contribution to this. To this end, the organisation must be divided into key-/core processes as well as management and support processes. These must be identified initially, then managed and finally monitored. The focus must not only be on the processes themselves, but also on their interactions, interfaces and performance measurements.

Through this approach, the process orientation demands and promotes a stronger examination of operational processes and responsibilities. The organisation is made more transparent and thus facilitates the clarity of the process structures. The employees recognize their role within the processes relevant to them as well as their role within the entire value chain.

For the success of the process-oriented approach and thus also for passing of the certification audit, it is important that an internal control loop exists between the incoming customer requirements (input) and the customer satisfaction (indirect output). The EN 9100:2018 requires the implementation of Deming’s PDCA cycle (Plan-Do-Check-Act) (see Fig. 2.1)². Consequently, the input of the customer, the requirements of the relevant interested parties, the context of the organisation and the operational resource management (Plan) form the input for the service provision. The value-added process (Do) and its output are subject to monitoring, performance measurements and analysis, product conformity and customer satisfaction (Check). Based on the results of this monitoring, management improvement measures must be derived, if planned results are not achieved in order to improve future service provision. Effective necessary actions shall be evaluated (Act). The entire cycle is subject to systematic leadership. The PDCA cycle must not only be reflected in the value creation process, but also, for example, in staff qualification and risk management as well as in the process for handling of nonconformities. All process specifications shall always take the PDCA cycle into account.

Fig. 2.1

PDCA cycle (following ISO 9001:2015, chap. 0.3)

Fig. 2.2

PDCA structure of the EN 9100:2018

Process Documentation

The type and scope of process documentation depends on the individual operational conditions. Methodically, however, only a visually anchored organisational and process concept can create sufficient transparency.

At the highest level, a process map is to be defined (cf. Fig. 4.​1) in order to obtain a complete overview of the company and its core processes. On the second level, which serves to describe individual processes, flow charts, flow diagrams or turtle diagrams (Turtles see Fig. 11.​2) are used. Tasks, processes and procedures, which were in a function-oriented approach summarised in writing, are visually shown here in process flow charts. (cf. e.g. Fig. 7.​1). The interactions between processes can be displayed, for example by using arrows.

Only the third level contains additional written instructions to the visualisations, as they are partly known from old procedural instructions. Through this multi-level structure, a process-oriented QM system creates transparency and thus emphasises on its advantages compared to written documentation describing the functions. These are:

The visualisation is analogous to the natural value creation process,

the focus is not on the hierarchy or departmental thinking, but on the process result,

the multi-level process structure (process maps, processes, activities) increases comprehensibility for the employee,

formerly isolated documentations are replaced by the sequencing of individual process steps with process flow orientation,

due to its clarity and clear structuring, this methodology is well suited for the induction of employees and as an instrument of inhouse training.

Although the process-oriented approach in QM documentation is therefore very user-friendly, employees must nevertheless be introduced to this form of presentation. They must rediscover their roles, activities and interfaces and understand how their actions are integrated into the overall operational value chain. This should be reflected in training plans.

Process Orientation in the Certification Audit

With EN 9100, process orientation not only plays an important role in the operational QM documentation. Since the standard was revised in 2009, certified organisations have also been subject to a stronger obligation to provide evidence of the key process performance . Finally, the process-oriented approach was intensified in the course of the last revision of EN 9101 in summer 2015. From thereon, the certification auditors must audit the key processes in a binding manner and align their records with them. Also,