EN 9110:2018
(Main)Quality Management Systems - Requirements for Aviation Maintenance Organizations
Quality Management Systems - Requirements for Aviation Maintenance Organizations
This document includes EN ISO 9001:2015 quality management system requirements and specifies additional civil and military aviation maintenance and continuing airworthiness 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 Luftfahrt-Instandhaltungsbetriebe
Dieses Dokument enthält die Anforderungen an Qualitätsmanagementsysteme nach EN ISO 9001:2015 ) und legt ergänzende Anforderungen, Definitionen und Anmerkungen für die Instandhaltung und die Aufrechterhaltung der Lufttüchtigkeit in der zivilen und militärischen Luftfahrt fest.
Es wird ausdrücklich darauf hingewiesen, dass die in diesem Dokument angegebenen Anforderungen eine Ergänzung (und keine Alternative) zu den Kundenanforderungen und geltenden gesetzlichen und behördlichen Anforderungen sind.
Sollte es einen Widerspruch zwischen den Anfor¬derungen dieses Dokumentes und Kundenanforderungen oder geltenden gesetzlichen und behördlichen Anforderungen geben, müssen die letztgenannten Anfor¬de¬rungen 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, ein-schließlich 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 Organismes d'Entretien de l'Aéronautique
La présente norme contient les exigences 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’entretien et la gestion du maintien de navigabilité pour l'industrie aéronautique civile et militaire.
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 organizacije za vzdrževanje letal
Ta dokument vključuje zahteve standarda EN ISO 9001:20152 za sisteme za vodenje kakovosti ter določa dodatne zahteve, opredelitve in opombe v zvezi z zahtevami za industrijo vzdrževanja civilnega in vojaškega letalstva in stalne plovnosti.
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
01-julij-2018
1DGRPHãþD
SIST EN 9110:2015
Sistemi vodenja kakovosti - Zahteve za organizacije za vzdrževanje letal
Quality Management Systems - Requirements for Aviation Maintenance Organizations
Qualitätsmanagementsysteme - Anforderungen für Luftfahrt-Instandhaltungsbetriebe
Systèmes de management de la Qualité - Exigences pour les Organismes d'Entretien de
l'Aéronautique
Ta slovenski standard je istoveten z: EN 9110:2018
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 9110
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 49.020 Supersedes EN 9110:2015
English Version
Quality Management Systems - Requirements for Aviation
Maintenance Organizations
Systèmes de Management de la Qualité - Exigences Qualitätsmanagementsysteme - Anforderungen für
pour les Organismes d'Entretien de l'Aéronautique Luftfahrt-Instandhaltungsbetriebe
This European Standard was approved by CEN on 10 March 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 9110:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Rationale . 5
Foreword . 5
Intended application . 6
0 Introduction . 6
0.1 General . 6
0.2 Quality management principles . 7
0.3 Process approach . 8
0.4 Relationship with other management system standards . 10
1 Scope . 11
2 Normative references . 11
3 Terms and definitions . 11
4 Context of the organization . 13
4.1 Understanding the organization and its context . 13
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. 14
5 Leadership . 15
5.1 Leadership and commitment . 15
5.2 Policy . 16
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 . 20
7 Support . 20
7.1 Resources . 20
7.2 Competence . 22
7.3 Awareness . 23
7.4 Communication . 23
7.5 Documented information . 24
8 Operation . 25
8.1 Operational planning and control . 25
8.2 Requirements for products and services . 29
8.3 Design and development of products and services . 30
8.4 Control of externally provided processes, products and services . 33
8.5 Production and service provision . 36
8.6 Release of products and services . 40
8.7 Control of nonconforming outputs . 40
9 Performance evaluation . 42
9.1 Monitoring, measurement, analysis and evaluation . 42
9.2 Internal audit . 43
9.3 Management review . 44
10 Improvement . 45
10.1 General . 45
10.2 Nonconformity and corrective action . 45
10.3 Continual improvement . 46
(informative) Clarification of new structure, terminology and concepts . 47
A.1 Structure and terminology . 47
A.2 Products and services . 47
A.3 Understanding the needs and expectations of interested parties . 48
A.4 Risk-based thinking . 48
A.5 Applicability . 49
A.6 Documented information . 49
A.7 Organizational knowledge . 50
A.8 Control of externally provided processes, products and services . 50
(informative) Other international standards on quality management and quality
management systems developed by ISO/TC 176 . 51
(informative) Other standards on quality management and quality management
systems developed by the international aerospace quality group . 55
(informative) Bibliography . 57
(informative) Aviation, space and defence bibliography . 59
Figures
Figure 1 — Schematic representation of the elements of a single process . 8
Figure 2 — Representation of the structure of this international standard in the PDCA cycle . 9
European foreword
This document (EN 9110:2018) 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 9110:2015.
According to the CEN-CENELEC Internal Regulations, the national standards organisations 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 9001:2015 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 throug
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