SIST EN 9120:2018
(Main)Quality Management Systems - Requirements for Aviation, Space and Defence Distributors
Quality Management Systems - Requirements for Aviation, Space and Defence Distributors
This document includes EN ISO 9001:20152 quality management system requirements and
specifies additional aviation, space and defence industry requirements, definitions and notes.
It is emphasized that the requirements specified in this document are complementary (not
alternative) to customer and applicable statutory and regulatory requirements.
If there is a conflict between the requirements of this document and customer or applicable
statutory or regulatory requirements, the latter shall take precedence.
This International Standard specifies requirements for a quality management system when an
organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer
and applicable statutory and regulatory requirements; and
b) aims to enhance customer satisfaction through the effective application of the system, including
processes for improvement of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any
organization, regardless of its type or size or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
Qualitätsmanagementsysteme - Anforderungen für Händler und Lagerhalter der Luftfahrt, Raumfahrt und Verteidigung
Dieses Dokument enthält die Anforderungen an Qualitätsmanagementsysteme nach EN ISO 9001:2015 ) und legt ergänzende Anforderungen, Definitionen und Anmerkungen für die Luftfahrt-, Raumfahrt- und Verteidigungsindustrie fest.
Es wird ausdrücklich darauf hingewiesen, dass die in diesem Dokument angegebenen Anforde¬run¬gen eine Ergänzung (und keine Alternative) zu den Kundenanforderungen und geltenden gesetzlichen und behördlichen Anforderungen sind.
Sollte es einen Widerspruch zwischen den Anfor¬de¬rungen dieses Dokumentes und Kundenanfor-derungen oder geltenden gesetzlichen und be¬hördlichen Anforderungen ge¬ben, müssen die letztgenannten Anforderun¬gen Vorrang haben.
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation
a) ihre Fähigkeit darlegen muss, beständig Produkte und Dienstleistungen bereitstellen zu können, die die Anforderungen der Kunden und die zutreffenden gesetzlichen und behördlichen Anforderungen erfüllen, und
b) danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, einschließlich der Prozesse zur Verbesserung des Systems und der Zusicherung der Einhaltung von Anforderungen der Kunden und von zutreffenden gesetzlichen und behördlichen Anforderungen.
Alle in dieser Internationalen Norm festgelegten Anforderungen sind allgemeiner Natur und auf jede Organisation zutreffend, unabhängig von deren Art oder Größe oder von der Art der von ihr bereitgestellten Produkte und Dienstleistungen.
ANMERKUNG 1 In dieser Internationalen Norm bezieht sich die Benennung "Produkt" bzw. "Dienstleistung" nur auf solche Produkte und Dienstleistungen, die für einen Kunden vorgesehen sind oder von diesem gefordert werden.
ANMERKUNG 2 Gesetzliche und behördliche Anforderungen können auch als rechtliche Anforderungen bezeichnet werden.
Systèmes de management de la Qualité - Exigences pour les distributeurs en aéronautique, spatial et défense
La présente norme contient les exigences de l'EN ISO 9001:2015 en matière de système de management de la qualité et spécifie les exigences, les définitions et les notes supplémentaires concernant l'industrie aéronautique, spatiale et de défense.
Il faut signaler que les exigences spécifiées dans la présente norme sont complémentaires aux exigences du client, légales et réglementaires applicables, mais ne les remplacent pas.
S'il existe un conflit entre les exigences de la présente norme et les exigences du client, légales ou réglementaires, ce sont ces dernières qui prévalent.
La présente Norme internationale spécifie les exigences relatives au système de management de la qualité lorsqu’un organisme :
a) doit démontrer son aptitude à fournir constamment des produits et des services conformes aux exigences des clients et aux exigences légales et réglementaires applicables, et
b) vise à accroître la satisfaction de ses clients par l’application efficace du système, y compris les processus pour l’amélioration du système et l’assurance de la conformité aux exigences des clients et aux exigences légales et réglementaires applicables.
Toutes les exigences de la présente Norme internationale sont génériques et prévues pour s’appliquer à tout organisme, quels que soient son type ou sa taille, ou les produits et services qu’il fournit.
NOTE 1 Dans la présente Norme internationale, les termes « produit » ou « service » s’appliquent uniquement aux produits et services destinés à, ou exigés par, un client.
NOTE 2 L’expression « legal requirement » recouvre en anglais le concept, utilisé dans la présente Norme internationale, d’exigence légale et réglementaire.
Sistemi vodenja kakovosti - Zahteve za distributerje na področju zračnega prometa, vesoljskih poletov in obrambe
Ta dokument vključuje zahteve standarda EN ISO 9001:20152 za sisteme za vodenje kakovosti ter določa dodatne zahteve, opredelitve in opombe za letalsko, vesoljsko in obrambno industrijo.
Poudariti je treba, da zahteve iz tega standarda dopolnjujejo (niso alternativna možnost) zahteve odjemalcev in ustrezne zakonske ter regulativne zahteve.
V primeru neskladnosti med zahtevami iz tega dokumenta in zahtevami odjemalcev ali ustreznimi zakonskimi ali regulativnimi zahtevami, imajo prednost ustrezne zakonske ali regulativne zahteve.
Ta mednarodni standard določa zahteve za sistem vodenja kakovosti. Uporablja se, kadar organizacija:
a) dokazuje svojo sposobnost, da dosledno dobavlja izdelke in storitve, ki izpolnjujejo zahteve odjemalcev in ustrezne zakonodajne ter regulativne zahteve, in
b) namerava izboljšati zadovoljstvo odjemalcev z učinkovito uporabo sistema, vključno s procesi za nenehno izboljševanje sistema in zagotavljanje skladnosti z zahtevami odjemalcev ter ustreznimi zakonodajnimi in regulativnimi zahtevami.
Vse zahteve, podane v tem mednarodnem standardu, so splošne in so namenjene uporabi v vseh
organizacijah, ne glede na vrsto ali velikost organizacije ali izdelke in storitve, ki jih dobavljajo.
OPOMBA 1: izraza »izdelek« ali »storitev« se v tem mednarodnem standardu nanašata samo na izdelke in storitve, ki so namenjene odjemalcu ali jih odjemalec zahteva.
OPOMBA 2: Zakonske in regulativne zahteve so lahko izražene kot pravne zahteve.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9120:2018
01-julij-2018
1DGRPHãþD
SIST EN 9120:2010
6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]DGLVWULEXWHUMHQDSRGURþMX]UDþQHJD
SURPHWDYHVROMVNLKSROHWRYLQREUDPEH
Quality Management Systems - Requirements for Aviation, Space and Defence
Distributors
Qualitätsmanagementsysteme - Anforderungen für Händler und Lagerhalter der
Luftfahrt, Raumfahrt und Verteidigung
Systèmes de management de la Qualité - Exigences pour les distributeurs en
aéronautique, spatial et défense
Ta slovenski standard je istoveten z: EN 9120:2018
ICS:
03.100.70 Sistemi vodenja Management systems
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
95.020 Vojaštvo na splošno Military in general
SIST EN 9120:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9120:2018
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SIST EN 9120:2018
EN 9120
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020; 95.040 Supersedes EN 9120:2010
English Version
Quality Management Systems - Requirements for Aviation,
Space and Defence Distributors
Systèmes de Management de la Qualité - Exigences Qualitätsmanagementsysteme - Anforderungen für
pour les distributeurs de l'Aéronautique, l'Espace et la Händler und Lagerhalter der Luftfahrt, Raumfahrt und
Défense Verteidigung
This European Standard was approved by CEN on 10 April 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 9120:2018 E
worldwide for CEN national Members.
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SIST EN 9120:2018
EN 9120:2018 (E)
Contents Page
European foreword . 5
Rationale . 6
Foreword . 6
Intended application . 7
0 Introduction . 7
0.1 General . 7
0.2 Quality management principles . 8
0.3 Process approach . 9
0.3.1 General . 9
0.3.2 Plan-do-check-act cycle. 10
0.3.3 Risk-based thinking . 10
0.4 Relationship with other management system standards . 11
1 Scope . 12
2 Normative references . 12
3 Terms and definitions . 12
4 Context of the organization . 14
4.1 Understanding the organization and its context . 14
4.2 Understanding the needs and expectations of interested parties . 14
4.3 Determining the scope of the quality management system. 14
4.4 Quality management system and its processes. 15
5 Leadership . 16
5.1 Leadership and commitment . 16
5.1.1 General . 16
5.1.2 Customer focus . 17
5.2 Policy . 17
5.2.1 Establishing the quality policy . 17
5.2.2 Communicating the quality policy . 17
5.3 Organizational roles, responsibilities and authorities . 17
6 Planning . 18
6.1 Actions to address risks and opportunities . 18
6.2 Quality objectives and planning to achieve them . 19
6.3 Planning of changes . 19
7 Support . 20
7.1 Resources . 20
7.1.1 General . 20
7.1.2 People . 20
7.1.3 Infrastructure . 20
7.1.4 Environment for the operation of processes . 20
7.1.5 Monitoring and measuring resources . 21
7.1.6 Organizational knowledge . 21
7.2 Competence . 22
7.3 Awareness . 22
7.4 Communication . 23
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7.5 Documented information . 23
7.5.1 General . 23
7.5.2 Creating and updating . 23
7.5.3 Control of documented information . 23
8 Operation . 25
8.1 Operational planning and control . 25
8.1.1 (Not used) . 26
8.1.2 Configuration management . 26
8.1.3 (Not used) . 27
8.1.4 Prevention of counterfeit parts . 27
8.1.5 Prevention of suspected unapproved parts . 27
8.2 Requirements for products and services . 27
8.2.1 Customer communication . 27
8.2.2 Determining the requirements for products and services . 28
8.2.3 Review of the requirements for products and services . 28
8.2.4 Changes to requirements for products and services . 29
8.3 Design and development of products and services . 29
8.3.1 General . 29
8.3.2 Design and development planning . 29
8.3.3 Design and development inputs . 29
8.3.4 Design and development controls . 30
8.3.5 Design and development outputs . 30
8.3.6 Design and development changes . 31
8.4 Control of externally provided processes, products and services . 31
8.4.1 General . 31
8.4.2 Type and extent of control . 32
8.4.3 Information for external providers . 33
8.5 Production and service provision . 34
8.5.1 Control of production and service provision . 34
8.5.2 Identification and traceability . 36
8.5.3 Property belonging to customers or external providers . 37
8.5.4 Preservation . 37
8.5.5 Post-delivery activities . 37
8.5.6 Control of changes . 38
8.6 Release of products and services . 38
8.7 Control of nonconforming outputs . 39
9 Performance evaluation . 40
9.1 Monitoring, measurement, analysis and evaluation . 40
9.1.1 General . 40
9.1.2 Customer satisfaction . 40
9.1.3 Analysis and evaluation . 41
9.2 Internal audit . 41
9.3 Management review . 42
9.3.1 General . 42
9.3.2 Management review inputs . 42
9.3.3 Management review outputs . 42
10 Improvement . 43
10.1 General . 43
10.2 Nonconformity and corrective action . 43
10.3 Continual improvement . 44
(informative) Clarification of new structure, terminology and concepts . 45
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A.1 Structure and terminology . 45
A.2 Products and services . 45
A.3 Understanding the needs and expectations of interested parties . 46
A.4 Risk-based thinking . 46
A.5 Applicability . 47
A.6 Documented information . 47
A.7 Organizational knowledge . 48
A.8 Control of externally provided processes, products and services . 48
(informative) Other international standards on quality management and quality
management systems developed by ISO/TC 176 . 49
(informative) Other standards on quality management and quality management
systems developed by the international aerospace quality group . 53
(informative) Bibliography . 57
(informative) Aviation, space and defence bibliography . 59
Figures
Figure 1 — Schematic representation of the elements of a single process . 9
Figure 2 — Representation of the structure of this international standard in the PDCA cycle . 10
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SIST EN 9120:2018
EN 9120:2018 (E)
European foreword
This document (EN 9120:2018) 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 9120:2010.
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.
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EN 9120:2018 (E)
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.
1
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.
1
ISO 9001:2015 is reproduced in this document with the permission of the International Organization for
Standardization, ISO. No parts of this standard may be reproduced in any form without the prior written consent of ISO at
copyright@iso.org. ISO Standards can be obtained from any ISO member and from the web site of the ISO Central
Secretariat at www.iso.org. Copyright remains with ISO.
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SIST EN 9120:2018
EN 9120:2018 (E)
Intended application
This document is intended for use by organizations that procure parts, materials and assemblies
and resell these products to a customer in the aviation, space and defence industries. This includes
organizations that procure products and split them into smaller quantities, including those that
coordinate a customer or regulatory controlled process on the product. This document is not
intended for organizations that maintain or repair products or for organizations that perform
work that affect or could affect product characteristics or conformity.
Organizations that design, develop or provide aviation, space and defence products and services
should use the IAQG-developed EN 9100 standard (see bibliography). This includes organizations
providing post-delivery activities, including the provision of maintenance, spare parts or materials
for their own products and services.
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).
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.
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EN 9120:2018 (E)
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 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, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement.
0.2 Quality management principles
This International Standard is based on the quality management principles described in EN ISO 9000.
The descriptions include a statement of each principle, a rationale of why the principle is important for
the organization, some examples of benefits associated with the principle and examples of typical
actions to improve the organization’s performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
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0.3 Process approach
0.3.1 General
This International Standard promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements. Specific requirements considered essential to the
adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended results. This approach enables the organizati
...
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