SIST 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 9001:20152 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
SIST EN 9110:2018
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
SIST EN 9110:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9110:2018
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SIST EN 9110:2018
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.
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EN 9110:2018 (E)
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
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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
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EN 9110:2018 (E)
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.
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EN 9110:2018 (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 9001:2015 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 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 civil
and military aviation industry organizations providing maintenance services, this document can
also be used in other industry sectors when a quality management system with additional
requirements over an EN ISO 9001:2015 system is needed.
1
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 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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Intended application
This document is intended for use by organizations whose primary business is providing
maintenance or continuing airworthiness management services for civil or military aviation
articles and products; and by original equipment manufacturers with maintenance, repair and
overhaul operations that are operated autonomously or that are substantially different from their
production operations.
Organizations that design, develop or provide aviation, space and defence products and services;
and organizations providing post-delivery activities, including the provision of maintenance, spare
parts or materials for their own products and services should use the IAQG-developed EN 9100
standard (see Bibliography).
Organizations that procure parts, materials and assemblies and resell 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.
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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 organization to
control the interrelationships and interdependencies among the processes of the system, so that the
overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be achieved
using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The
monitoring and measuring check points, which are necessary for control, are specific to each process
and will vary depending on the related risks.
Figure 1 — Schematic representation of the elements of a single process
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0.3.2 Plan-do-check-act cycle
The PDCA cycle can be applied to all processes and to the quality management system as a whole.
Figure 2 illustrates how 4 to 10 can be grouped in relation to the PDCA cycle.
The PDCA cycle can be briefly described as follows:
— plan: establish the objectives of the system and its processes and the resources needed to deliver
results in accordance with customers’ requirements and the organization’s policies and identify and
address risks and opportunities;
— do: implement what was planned;
— check: monitor and (where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities and report the results;
— act: take actions to improve performance, as necessary.
Figure 2 — Representation of the structure of this international standard in the PDCA cycle
0.3.3 Risk-based thinking
Risk-based thinking (see A.4) is essential for achieving an effective quality management system. The
concept of risk-based thinking has been implicit in previous editions of this International Standard
including, for example, carrying out preventive action to eliminate potential nonconformities, analysing
any nonconformities that do occur and taking action to prevent recurrence that is appropriate for the
effects of the nonconformity.
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To conform to the requirements of this International Standard, an organization needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
establishes a basis for increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.
Opportunities can arise as a result of a situation favourable to achieving an intended result, for example,
a set of circumstances that allow the organization to attract customers, develop new products and
services, reduce waste or improve productivity. Actions to address opportunities can also include
consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have
positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk result in opportunities.
0.4 Relationship with other management system standards
This International Standard applies the framework developed by ISO to improve alignment among its
International Standards for management systems (see A.1).
This International Standard enables an organization to use the process approach, coupled with the
PDCA cycle and risk-based thinking, to align or integrate its quality management system with the
requirements of other management system standards.
This International Standard relates to EN ISO 9000 and EN ISO 9004 as follows:
— EN ISO 9000, Quality management systems — Fundamentals and vocabulary, provides essential
background for the proper understanding and implementation of this International Standard;
— EN ISO 9004, Managing for the sustained success of an organization — A quality management
approach, provides guidance for organizations that choose to progress beyond the requirements of
this International Standard.
Annex B provides details of other International Standards on quality management and quality
management systems that have been developed by ISO/TC 176.
This International Standard does not include requirements specific to other management systems, such
as those for environmental management, occupational health and safety management or financial
management.
Sector-specific quality management system standards based on the requirements of this International
Standard have been developed for a number of sectors. Some of these standards specify additional
quality management system requirements, while others are limited to providing guidance to the
application of this International Standard within the particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard and
the previous edition (EN ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at:
www.iso.org/tc176/sc02/public.
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1 Scope
2
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 9000:2015, Quality mana
...
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