EN 9100:2018

SLOVENSKI STANDARD
01-julij-2018
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SIST EN 9100:2009
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Quality Management Systems - Requirements for Aviation, Space and Defense
Organizations
Qualitätsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt,
Raumfahrt und Verteidigung
Systèmes de management de la Qualité - Exigences des Organisations pour l'Aviation,
l'Espace et la Défense
Ta slovenski standard je istoveten z: EN 9100:2018
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 9100
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9100:2009
English Version
Quality Management Systems - Requirements for Aviation,
Space and Defence Organizations
Systèmes de Management de la Qualité - Exigences Qualitätsmanagementsysteme - Anforderungen an
pour les Organismes de l'Aéronautique, l'Espace et la Organisationen der Luftfahrt, Raumfahrt und
Défense Verteidigung
This European Standard was approved by CEN on 27 February 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9100:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Rationale . 4
Foreword . 4
Intended application . 5
0 Introduction . 5
1 Scope . 10
2 Normative references . 10
3 Terms and definitions . 10
4 Context of the organization . 11
5 Leadership . 14
6 Planning . 16
7 Support . 17
8 Operation . 22
9 Performance evaluation . 39
10 Improvement . 42
(informative) Clarification of new structure, terminology and concepts . 44
(informative) Other international standards on quality management and quality
management systems developed by ISO/TC 176 . 48
(informative) Other standards on quality management and quality management
systems developed by the international aerospace quality group . 52
(informative) Bibliography . 56
(informative) Aviation , space and defence bibliography . 58

Figures
Figure 1 — Schematic representation of the elements of a single process . 7
Figure 2 — Representation of the structure of this international standard in the PDCA cycle . 8

European foreword
This document (EN 9100:2018) has been prepared by the Aerospace and Defence Industries
Association of Europe - Standardization (ASD-STAN).
After enquiries and votes carried out in accordance with the rules of this Association, this Standard has
received the approval of the National Associations and the Official Services of the member countries of
ASD, prior to its presentation to CEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN 9100:2009.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Rationale
This document has been revised to incorporate the new clause structure and content of
EN ISO 9001:2015. In addition, industry requirements, definitions and notes have been revised in
response to both EN ISO 9001 revisions and stakeholder needs.
Foreword
To assure customer satisfaction, aviation, space and defence organizations must provide and
continually improve, safe and reliable products and services that meet or exceed customer and
applicable statutory and regulatory requirements. The globalization of the industry and the
resulting diversity of regional and national requirements and expectations have complicated this
objective. Organizations have the challenge of purchasing products and services from external
providers throughout the world and at all levels of the supply chain. External providers have the
challenge of delivering products and services to multiple customers having varying quality
requirements and expectations.
Industry has established the International Aerospace Quality Group (IAQG), with representatives
from aviation, space and defence companies in the Americas, Asia/Pacific and Europe, to
implement initiatives that make significant improvements in quality and reductions in cost
throughout the value stream. This document has been prepared by the IAQG.
This document standardizes quality management system requirements to the greatest extent
possible and can be used at all levels of the supply chain by organizations around the world. Its use
should result in improved quality, cost and delivery performance through the reduction or
elimination of organization-unique requirements, effective implementation of the quality
management system and wider application of good practice. While primarily developed for the
aviation, space and defence industry, this document can also be used in other industry sectors
when a quality management system with additional requirements over an EN ISO 9001 system is
needed.
This document includes EN ISO 9001:2015 quality management system requirements and
specifies additional aviation, space and defence industry requirements, definitions and notes as
shown in bold, italic text.
With the permission of the International Organization for Standardization (ISO). The complete EN ISO 9001
standard can be obtained from any ISO member or from the ISO Central Secretariat: BIBC II, Chemin de Blandonnet 8,
CP 401, 1214 Vernier, Geneva, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO.
Intended application
This document is intended for use by organizations that design, develop, or provide aviation, space
and defence products and services; and by organizations providing post-delivery activities,
including the provision of maintenance, spare parts, or materials for their own products and
services.
NOTE Organizations whose products are deliverable software, or contain deliverable software, should
use the IAQG-developed EN 9115 standard (see Bibliography) when planning and evaluating the software
design, development, or management activities of the organization. The EN 9115 standard provides
guidance to the requirements of the EN 9100 standard when it is desired to add “software” to the EN 9100
quality management system scope.
Organizations whose primary business is providing maintenance or continuing airworthiness
management services for civil or military aviation articles and products; and original equipment
manufacturers with maintenance, repair and overhaul operations that are operated
autonomously, or that are substantially different from their production operations; should use the
IAQG-developed EN 9110 standard (see Bibliography).
Organizations that procure parts, materials and assemblies and resells these products to a
customer in the aviation, space and defence industry should use the IAQG-developed EN 9120
standard (see Bibliography). This includes organizations that procure products and split them into
smaller quantities, as well as those that coordinate a customer or regulatory controlled process on
the product.
0 Introduction
0.1 General
The adoption of a quality management system is a strategic decision for an organization that can help to
improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this
International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are
complementary to requirements for products and services.
This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
its quality management system to deviate from the planned results, to put in place preventive controls
to minimize negative effects and to make maximum use of opportunities as they arise (see clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a challenge for
organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change,
...