SIST EN 9110:2015
(Main)Quality Management Systems - Requirements for Aviation Maintenance Organizations
Quality Management Systems - Requirements for Aviation Maintenance Organizations
This standard includes ISO 9001:2008 1) 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.
Qualitätsmanagementsysteme - Anforderungen für Luftfahrt-Wartungsfirmen
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9110:2015
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
SIST EN 9110:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9110:2015
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SIST EN 9110:2015
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.
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SIST EN 9110:2015
EN 9110:2015 (E)
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.
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EN 9110:2015 (E)
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
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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 . 23
7.4.2 Purchasing information . 24
7.4.3 Verification of purchased product . 25
7.5 Production and service provision . 25
7.5.1 Control of production and service provision . 25
7.5.1.1 Maintenance process verification . 27
7.5.1.2 Control of maintenance process changes . 27
7.5.1.3 Control of maintenance equipment, tools, and software programs . 27
7.5.1.4 Post-delivery support . 27
7.5.2 Validation of processes for production and service provision . 27
7.5.3 Identification and traceability . 28
7.5.4 Customer property. 28
7.5.5 Preservation of product . 29
7.6 Control of monitoring and measuring equipment . 29
8 Measurement, analysis and improvement . 30
8.1 General . 30
8.2 Monitoring and measurement . 30
8.2.1 Customer satisfaction . 30
8.2.2 Internal audit . 31
8.2.3 Monitoring and measurement of processes . 31
8.2.4 Monitoring and measurement of product . 31
8.3 Control of nonconforming product . 32
8.4 Analysis of data . 33
8.5 Improvement . 34
8.5.1 Continual improvement . 34
8.5.2 Corrective action. 34
8.5.3 Preventive action . 34
9 Notes . 35
Bibliography . 36
Figure
Figure 1 — Model of a process-based quality management system .7
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SIST EN 9110:2015
EN 9110:2015 (E)
Foreword
This document (EN 9110:2015) 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 August 2015, and conflicting national standards shall be withdrawn at
the latest by August 2015.
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 9110:2010.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
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EN 9110:2015 (E)
Introduction
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design
and implementation of an organization‘s quality management system is influenced by:
a. its organizational environment, changes in that environment, and the risks associated with that
environment,
b. its varying needs,
c. its particular objectives,
d. the products it provides,
e. the processes it employs,
f. its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to
requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to
assess the organization's ability to meet customer, statutory, and regulatory requirements applicable to the
product, and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration
during the development of this International Standard.
0.2 Process approach
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.
For an organization to function effectively, it has to determine and manage numerous linked activities. An activity
or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can
be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred to as
the "process approach".
An advantage of the process approach is the on-going control that it provides over the linkage between the
individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of:
a. understanding and meeting requirements,
b. the need to consider processes in terms of added value,
c. obtaining results of process performance and effectiveness, and
d. continual improvement of processes based on objective measurement.
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EN 9110:2015 (E)
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages
presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining
requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to
customer perception as to whether the organization has met the customer requirements. The model shown in
Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed
level.
NOTE In addition, the methodology known as "Plan-Do-Check-Act" (PDCA) can be applied to all processes. PDCA
can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer
requirements and the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the
product and report the results.
Act: take actions to continually improve process performance.
Figure 1 — Model of a process-based quality management system
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EN 9110:2015 (E)
Quality management systems — Requirements
1 Scope
1.1 General
1)
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.
1) With the permission of the International Organization for Standardization (ISO). The complete standard can be
obtained from any ISO member or from the ISO Central Secretariat: 1, Ch. de la Voie-Creuse, Case postale 56,
CH-1211 Geneva 20, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO.
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EN 9110:2015 (E)
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term "product" occurs, it can also mean "service".
NOTE In the context of this standard, the term "product" is synonymous with the term "maintenance service".
3.1
Airworthy
state of an article conforming to its type design and being in a condition for safe operation
3.2
Article
material, part, component, assembly, appliance, propeller, aircraft engine, airframe, or aircraft which is
listed by the design organization as eligible for installation in product or included in the design data
approved by the authority
3.3
Authority
the aviation authority having jurisdiction over the manufacturer, aircraft owner/operator or maintenance
organization; the authority could be civil or military
3.4
Certified personnel
personnel qualified by an external/internal competent body to carry out special tasks (e.g.,
non-destructive testing certified personnel, licensed maintenance personnel)
3.5
Certifying staff
personnel authorized by the maintenance organization to sign the release certificate for an article after
maintenance
3.6
Counterfeit part
an article produced or altered to imitate or resemble an “approved artic
...
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