EN 9110:2015

Quality Management Systems - Requirements for Aviation Maintenance Organizations

1.1   General
This standard includes ISO 9001:2008  ) quality management system requirements and specifies additional aviation maintenance industry requirements, definitions and notes as shown in bold, italic text.
NOTE 1   Baseline aviation maintenance requirements originate from IAQG developed 9100:2009 standard; modifications were made, as required, to address maintenance industry specific requirements.
It is emphasized that the requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.
This International Standard specifies requirements for a quality management system where an organization:
a.   needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b.   aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
NOTE 2   In this International Standard, the term "product" only applies to:
a.   product intended for, or required by, a customer,
b.   any intended output resulting from the product realization processes.
NOTE 3   Statutory and regulatory requirements can be expressed as legal requirements.
1.2   Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
This standard has been developed to benefit maintenance organizations that choose to adopt it, whether or not holders of a National Aviation Authority (NAA) repair station certificate. This standard is intended for use by maintenance organizations whose primary business is providing maintenance services for aviation commercial and military products; and for Original Equipment Manufacturer (OEM) organizations with maintenance operated autonomously or that are substantially different from their manufacturing/production operations.

Qualitätsmanagementsysteme - Anforderungen für Luftfahrt-Instandhaltungsbetriebe

Systèmes de management de la qualité - Exigences pour les Organismes d'Entretien de l'Aéronautique

1.1   Généralités
La présente norme comporte les exigences en matière de système de management de la qualité développées dans l'ISO 9001:2008  ) et spécifie les exigences, les définitions et les notes supplémentaires concernant les organismes d’entretien de l'industrie aéronautique ; celles-ci sont indiquées par du texte en gras et en italique.
NOTE 1   Les exigences de base relatives à l’entretien aéronautique sont issues de la norme 9100 :2009    développée par l’IAQG ; des modifications abordant les exigences particulières à l’industrie en matière    d’entretien ont été apportées, selon besoin.
Il faut signaler que les exigences spécifiées dans la présente norme sont complémentaires aux exigences contractuelles, légales et réglementaires applicables, mais ne les remplacent pas. En cas de conflit entre les exigences de la présente norme et les exigences légales ou réglementaires, ce sont ces dernières qui prévalent.
La présente Norme Européenne spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme :
a.   doit démontrer son aptitude à fournir régulièrement un produit conforme 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 continue du système et l'assurance de la conformité aux exigences des clients et aux exigences légales et réglementaires applicables.
NOTE 2   Dans la présente Norme Européenne, le terme "produit" s'applique uniquement :
a.   au produit destiné à, ou exigé par un client ;
b.   à tout élément issu des processus de réalisation de produits.
NOTE 3   L'expression "legal requirement" recouvre en anglais le concept, utilisé dans la présente Norme Européenne, d'exigence légale et réglementaire.
1.2   Périmètre d’application
Toutes les exigences de la présente Norme Européenne sont génériques et prévues pour s'appliquer à tout organisme, quels que soient son type, sa taille et le produit fourni.
Lorsque l'une ou plusieurs exigences de la présente Norme Européenne ne peuvent être appliquées en raison de la nature d'un organisme et de son produit, leur exclusion peut être envisagée.
Lorsque des exclusions sont faites, les demandes de conformité à la présente Norme Européenne ne sont acceptables que si ces exclusions se limitent aux exigences de l'Article 7 et qu'elles n'ont pas d’incidence sur l'aptitude ou la responsabilité des organismes à fournir un produit conforme aux exigences des clients et aux exigences légales et réglementaires applicables.
La présente norme a été conçue pour les organismes d’entretien choisissant de l’utiliser, qu’ils soient titulaires ou pas, d’un agrément d’organisme d’entretien délivré par l'Autorité nationale de navigabilité (NAA). Elle est destinée à être utilisée par les organismes d'entretien dont l'activité principale est de fournir des prestations d’entretien pour les produits du secteur aéronautique, civil et militaire et les organismes/ensembliers (OEM) dont les opérations d’entretien sont autonomes ou sont en grande partie différentes des opérations de fabrication/production.

Sistemi vodenja kakovosti - Zahteve za organizacije za vzdrževanje letal

Ta standard zajema ISO 9001:2008 1) zahteve za sisteme vodenja kakovosti ter določa dodatne zahteve za industrijo vzdrževanja letal, definicije in opombe, kot je prikazano v krepkem, poševnem besedilu.
OPOMBA 1: Osnovne zahteve za vzdrževanje letal izhajajo iz standarda 9100:2009, razvitega na podlagi IAQG; opravljene so bile zahtevane spremembe, ki so obravnavale zahteve, specifične za industrijo vzdrževanja letal. Poudariti je treba, da zahteve iz tega standarda dopolnjujejo (niso alternativna možnost) pogodbene in ustrezne zakonske ter regulativne zahteve. V primeru neskladnosti med zahtevami iz tega standarda in ustreznimi zakonskimi ali regulativnimi zahtevami imajo prednost ustrezne zakonske ali regulativne zahteve.
Ta mednarodni standard specificira zahteve za sistem vodenja kakovosti. Uporablja se, kadar organizacija:
a. mora dokazati svojo sposobnost, da dosledno dobavlja proizvode, ki izpolnjujejo zahteve odjemalcev ter ustrezne zakonske in 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 zakonskimi in regulativnimi zahtevami.
OPOMBA 2: V tem mednarodnem standardu se izraz »proizvod« nanaša samo na:
a. proizvod, ki je namenjen odjemalcu ali ki ga odjemalec zahteva,
b. vsak načrtovani izhod kot rezultat procesa realizacije proizvoda.
OPOMBA 3: Zakonske in regulativne zahteve so lahko izražene kot pravne zahteve.

General Information

• Status: Withdrawn
• Publication Date: 17-Feb-2015
• Withdrawal Date: 29-May-2018
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 49.020 - Aircraft and space vehicles in general
• Technical Committee: ASD-STAN - Aerospace
• Drafting Committee: ASD-STAN/D 6 - Quality
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-May-2018
• Ref Project: SIST EN 9110:2015 - Quality Management Systems - Requirements for Aviation Maintenance Organizations

Relations

• Replaces: EN 9110:2010 - Quality Management Systems - Requirements for Aviation Maintenance Organizations
• Effective Date: 23-Jul-2014
• Replaced By: EN 9110:2018 - Quality Management Systems - Requirements for Aviation Maintenance Organizations
• Effective Date: 16-Nov-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2015
1DGRPHãþD
SIST EN 9110:2012
Sistemi vodenja kakovosti - Zahteve za organizacije za vzdrževanje letal
Quality Management Systems - Requirements for Aviation Maintenance Organizations
Qualitätsmanagementsysteme - Anforderungen für Luftfahrt-Wartungsfirmen
Systèmes de management de la Qualité - Exigences pour les Organismes d'Entretien de
l'Aéronautique
Ta slovenski standard je istoveten z: EN 9110:2015
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.

EUROPEAN STANDARD
EN 9110
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2015
ICS 03.120.10; 49.020 Supersedes EN 9110:2010
English Version
Quality Management Systems - Requirements for Aviation
Maintenance Organizations
Systèmes de management de la Qualité - Exigences pour Qualitätsmanagementsysteme - Anforderungen für
les Organismes d'Entretien de l'Aéronautique Luftfahrt-Instandhaltungsbetriebe
This European Standard was approved by CEN on 29 November 2014.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9110:2015 E
worldwide for CEN national Members.

RATIONALE
This standard has been revised to address stakeholder needs through the addition of definitions and
clarification of existing requirements to resolve interpretation issues, and incorporate editorial
corrections.
FOREWORD
To assure customer satisfaction, aviation and defence organizations must produce, maintain, repair
and continually improve, safe, reliable products 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 from suppliers throughout the world and at all levels of the
supply chain. Suppliers have the challenge of delivering products to multiple customers having
varying quality requirements and expectations.
Industry has established the International Aerospace Quality Group (IAQG), with representatives from
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 standard 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, schedule, and cost performance by the reduction or elimination of
organization-unique requirements and wider application of good practice. While primarily developed
for the aviation and defence industry organizations providing maintenance services, this standard can
also be used in other industry sectors where a quality management system with additional
requirements over an ISO 9001 system is needed.
Contents Page
RATIONALE . 2
FOREWORD . 2
Foreword . 5
Introduction . 6
0.1 General . 6
0.2 Process approach . 6
Quality management systems — Requirements . 8
1 Scope . 8
1.1 General . 8
1.2 Application . 8
2 Normative references . 9
3 Terms and definitions . 9
4 Quality management system . 11
4.1 General requirements . 11
4.2 Documentation requirements. 12
4.2.1 General . 12
4.2.2 Quality manual . 12
4.2.3 Control of documents . 13
4.2.4 Control of records . 13
5 Management responsibility . 14
5.1 Management commitment . 14
5.2 Customer focus . 14
5.3 Quality policy . 14
5.4 Planning. 14
5.4.1 Quality objectives . 14
5.4.2 Quality management system planning . 15
5.4.3 Safety objectives . 15
5.5 Responsibility, authority and communication . 15
5.5.1 Responsibility and authority . 15
5.5.1.1 Accountable manager . 15
5.5.1.2 Maintenance manager(s) . 15
5.5.2 Management representative . 15
5.5.3 Internal communication . 16
5.6 Management review . 16
5.6.1 General . 16
5.6.2 Review input . 16
5.6.3 Review output . 16
5.7 Safety policy . 16
6 Resource management . 17
6.1 Provision of resources . 17
6.2 Human resources . 17
6.2.1 General . 17
6.2.2 Competence, training and awareness . 17
6.3 Infrastructure . 18
6.4 Work environment . 18
7 Product realization. 18
7.1 Planning of product realization . 18
7.1.1 Project management . 19
7.1.2 Risk management . 19
7.1.3 Configuration management . 19
7.1.4 Control of work transfers . 20
7.2 Customer-related processes . 20
7.2.1 Determination of requirements related to the product . 20
7.2.2 Review of requirements related to the product . 20
7.2.3 Customer communication . 21
7.3 Design and development . 21
7.3.1 Design and development planning . 21
7.3.2 Design and development inputs . 21
7.3.3 Design and development outputs . 22
7.3.4 Design and development review . 22
7.3.5 Design and development verification . 22
7.3.6 Design and development validation . 23
7.3.6.1 Design and development verification and validation testing . 23
7.3.6.2 Design and development verification and validation documentation . 23
7.3.7 Control of design and development changes . 23
7.4 Purchasing . 23
7.4.1 Purchasing process .
...