SIST EN 9100:2009
(Main)Quality Management Systems - Requirements for Aviation, Space and Defense Organizations
Quality Management Systems - Requirements for Aviation, Space and Defense Organizations
This standard includes ISO 9001:2008 1 quality management system requirements and specifies
additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text. 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 1 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 2 Statutory and regulatory requirements can be expressed as legal requirements.
Qualitätsmanagementsysteme — Anforderungen an Organisationen der Luftfahrt, Raumfahrt und Verteidigung
Diese Norm enthält die Anforderungen an das Qualitätsmanagementsystem nach ISO 9001:20081) und
legt ergänzende Anforderungen, Definitionen und Anmerkungen für die Luft-, Raumfahrt- und
Verteidigungsindustrie, fest, die in Fettdruck und Kursivschrift angegeben werden.
Es wird ausdrücklich darauf hingewiesen, dass die in dieser Norm angegebenen Anforderungen eine
Ergänzung (und keine Alternative) zu den vertraglichen und geltenden gesetzlichen und regelsetzenden
Anforderungen sind. Sollte es einen Widerspruch zwischen den Anforderungen dieser Norm und
den geltenden gesetzlichen und regelsetzenden Anforderungen geben, müssen die letztgenannten
Anforderungen Vorrang haben.
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation
a) ihre Fähigkeit zur ständigen Bereitstellung von Produkten darzulegen hat, die die Anforderungen der
Kunden und zutreffenden gesetzlichen und behördlichen Anforderungen erfüllen und
b) danach strebt, die Kundenzufriedenheit durch die wirksame Anwendung des Systems zu erhöhen, einschließlich
der Prozesse zur ständigen Verbesserung des Systems und der Zusicherung der Einhaltung
der Anforderungen der Kunden und der zutreffenden gesetzlichen und behördlichen Anforderungen.
ANMERKUNG 1 In dieser Internationalen Norm bezieht sich die Benennung „Produkt“ nur auf
a) solche Produkte, die für einen Kunden vorgesehen sind oder von diesem gefordert werden,
b) alle beabsichtigten Ergebnisse der Produktrealisierungsprozesse.
ANMERKUNG 2 Gesetzliche und behördliche Anforderungen können auch als rechtliche Anforderungen bezeichnet
werden.
Systèmes de management de la Qualité — Exigences des Organisations pour l'Aviation, l'Espace et la Défense
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 l'industrie aéronautique, spatiale et de défense ; celles-ci sont indiquées par du texte en gras et en italique.
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 Internationale 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,
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 réglementaires applicables.
NOTE 1 Dans la présente Norme Internationale, le terme "produit" s'applique :
a) au produit destiné à, ou exigé par un client,
b) à tout élément issu des processus de réalisation de produits.
NOTE 2 L'expression "legal requirement" recouvre en anglais le concept, utilisé dans la présente Norme Internationale, d'exigence légale et réglementaire.
1.2 Périmètre d'application
Toutes les exigences de la présente Norme Internationale 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 Internationale 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 Internationale 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 est destinée à être utilisée par les organismes qui conçoivent, développent et/ou fabriquent des produits aéronautiques, spatiaux et de défense et par les organismes qui fournissent un soutien après la livraison, y compris la fourniture de la maintenance, des rechanges ou des matériaux pour leurs propres produits.
Les organismes dont l’activité principale est de fournir des prestations de maintenance, réparation et révision pour les produits du secteur aéronautique civil et/ou militaire, et les organismes/ ensembliers dont les opérations de maintenance, réparation et révision sont autonomes, ou sont en grande partie différentes des opérations de fabrication/production, devraient utiliser la norme 9110 développée par l'IAQG (voir la Bibliographie).
Les organismes qui approvisionnent des pièces, des matériaux et des ensembles et revendent ces produits à un client des secteurs aéronautiques, spatiaux et de défense, y compris les organismes qui approvisionnent des produits et les reconditionnent en plus petites quantités pour les revendre, devraient utiliser la norme 9120 développée par l'IAQG (voir la Bibliographie).
Sistemi vodenja kakovosti - Zahteve za organizacije na področju zračnega prometa, vesoljskih poletov in obrambe
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9100:2009
01-oktober-2009
1DGRPHãþD
SIST EN 9100:2004
6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]DRUJDQL]DFLMHQDSRGURþMX]UDþQHJD
SURPHWDYHVROMVNLKSROHWRYLQREUDPEH
Quality Management Systems - Requirements for Aviation, Space and Defense
Organizations
Qualitätsmanagementsysteme — Anforderungen an Organisationen der Luftfahrt,
Raumfahrt und Verteidigung
Systèmes de management de la Qualité — Exigences des Organisations pour l'Aviation,
l'Espace et la Défense
Ta slovenski standard je istoveten z: EN 9100:2009
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 9100:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9100:2009
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SIST EN 9100:2009
EUROPEAN STANDARD
EN 9100
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2009
ICS 03.120.10; 49.020 Supersedes EN 9100:2003
English Version
Quality Management Systems - Requirements for Aviation,
Space and Defense Organizations
Systèmes de management de la Qualité - Exigences des Qualitätsmanagementsysteme - Anforderungen an
Organisations pour l'Aviation, l'Espace et la Défense Organisationen der Luftfahrt, Raumfahrt und Verteidigung
This European Standard was approved by CEN on 3 July 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9100:2009: E
worldwide for CEN national Members.
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SIST EN 9100:2009
EN 9100:2009 (E)
Contents Page
Foreword .4
0 INTRODUCTION .5
0.1 General .5
0.2 Process approach .5
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS .7
1 SCOPE .7
1.1 General .7
1.2 Application .7
2 NORMATIVE REFERENCES .8
3 TERMS AND DEFINITIONS .8
3.1 Risk .8
3.2 Special requirements .8
3.3 Critical items .8
3.4 Key characteristic.9
4 QUALITY MANAGEMENT SYSTEM.9
4.1 General requirements .9
4.2 Documentation Requirements . 10
4.2.1 General . 10
4.2.2 Quality Manual . 10
4.2.3 Control of Documents . 10
4.2.4 Control of Records . 11
5 MANAGEMENT RESPONSIBILITY . 11
5.1 Management Commitment . 11
5.2 Customer Focus . 11
5.3 Quality Policy . 12
5.4 Planning . 12
5.4.1 Quality Objectives . 12
5.4.2 Quality Management System Planning . 12
5.5 Responsibility, Authority and Communication . 12
5.5.1 Responsibility and Authority . 12
5.5.2 Management Representative . 12
5.5.3 Internal Communication . 13
5.6 Management Review . 13
5.6.1 General . 13
5.6.2 Review Input . 13
5.6.3 Review Ouput . 13
6 RESOURCE MANAGEMENT . 14
6.1 Provision of Resources . 14
6.2 Human Resources . 14
6.2.1 General . 14
6.2.2 Competence, Training and Awareness . 14
6.3 Infrastructure . 14
6.4 Work Environment. 14
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EN 9100:2009 (E)
7 PRODUCT REALIZATION . 15
7.1 Planning of Product Realization . 15
7.1.1 Project Management . 15
7.1.2 Risk Management . 15
7.1.3 Configuration Management. 16
7.1.4 Control of Work Transfers . 16
7.2 Customer-related processes. 16
7.2.1 Determination of Requirements Related to the Product . 16
7.2.2 Review of Requirements Related to the Product . 16
7.2.3 Customer Communication . 17
7.3 Design and Development . 17
7.3.1 Design and Development Planning . 17
7.3.2 Design and Development Inputs . 18
7.3.3 Design and Development Outputs . 18
7.3.4 Design and Development Review . 19
7.3.5 Design and Development Verification . 19
7.3.6 Design and Development Validation . 19
7.3.6.1 Design and Development Verification and Validation Testing . 19
7.3.6.2 Design and Development Verification and Validation Documentation . 19
7.3.7 Control of Design and Development Changes. 19
7.4 Purchasing . 20
7.4.1 Purchasing Process . 20
7.4.2 Purchasing Information . 20
7.4.3 Verification of Purchased Product . 21
7.5 Production and Service Provision . 22
7.5.1 Control of Production and Service Provision . 22
7.5.1.1 Production Process Verification . 22
7.5.1.2 Control of Production Process Changes . 23
7.5.1.3 Control of Production Equipment, Tools and Software Programs . 23
7.5.1.4 Post-Delivery Support . 23
7.5.2 Validation of Processes for Production and Service Provision . 23
7.5.3 Identification and Traceability . 24
7.5.4 Customer Property . 24
7.5.5 Preservation of Product . 24
7.6 Control of Monitoring and Measuring Equipment . 25
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT . 26
8.1 General . 26
8.2 Monitoring and Measurement . 26
8.2.1 Customer Satisfaction . 26
8.2.2 Internal Audit . 26
8.2.3 Monitoring and Measurement of Processes . 27
8.2.4 Monitoring and Measurement of Product . 27
8.3 Control of Nonconforming Product . 28
8.4 Analysis of Data . 29
8.5 Improvement . 29
8.5.1 Continual Improvement . 29
8.5.2 Corrective Action . 30
8.5.3 Preventive Action . 30
BIBLIOGRAPHY . 31
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SIST EN 9100:2009
EN 9100:2009 (E)
Foreword
This document (EN 9100:2009) 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 February 2010, and conflicting national standards shall be withdrawn
at the latest by February 2010.
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 9100:2003.
This standard has been revised to incorporate the requirements of ISO 9001:2008. In addition, industry
requirements, definitions and notes have been revised and additional requirements have been included in
response to stakeholder needs.
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, space and
defense industry, 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.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
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SIST EN 9100:2009
EN 9100:2009 (E)
0 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 ongoing 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,
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SIST EN 9100:2009
EN 9100:2009 (E)
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.
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.
Continual improvement of
the quality management system
Management
responsibility
Customers
Customers
Measurement,
Resource
Satisfaction
analysis and
management
improvement
Input Output
Product
Requirements
Product
realization
Key
Value-adding activities
Information flow
Figure 1 — Model of a process-based quality management system
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SIST EN 9100:2009
EN 9100:2009 (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, space and defense industry requirements, definitions and notes as shown in bold,
italic text.
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 1 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 2 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 is intended for use by organizations that design, develop and/or produce aviation,
space and defense products; and by organizations providing post-delivery support, including the
provision of maintenance, spare parts or materials for their own products.
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 9100:2009 (E)
Organizations whose primary business is providing maintenance, repair and overhaul services for
aviation commercial and military products; and original equipment manufacturers with maintenance,
repair and overhaul operations that operate autonomously, or that are substantially different from
their manufacturing/production operations; should use the IAQG-developed 9110 standard (see
Bibliography).
Organizations that procure parts, materials and assemblies and resell these products to a customer in
the aviation, space and defense industries, including organizations that procure products and split
them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see
Bibliography).
2 NORMATIVE REFERENCES
The following referenced documents are indispensable for the application 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.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
ISO 9001:2008, Quality management systems — Requirements
3 TERMS AND DEFINITIONS
For the purposes of this document, the terms and definitions given in ISO 9000:2005 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean
“service”.
3.1 Risk
An undesirable situation or circumstance that has both a likelihood of occurring and a potentially
negative consequence.
3.2 Special requirements
Those requirements identified by the customer, or determined by the organization, which have high
risks to being achieved, thus requiring their inclusion in the risk management process. Factors used
in the determination of special requirements include product or process complexity, past experience
and product or process maturity. Examples of special requirements include performance
requirements imposed by the customer that are at the limit of the industry’s capability, or
requirements determined by the organization to be at the limit of its technical or process capabilities.
3.3 Critical items
Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on
the product realization and use of the product; including safety, performance, form, fit, function,
producibility, service life, etc.; that require specific actions to ensure they are adequately managed.
Examples of critical items include safety critical items, fracture critical items, mission critical items,
key characteristics, etc.
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EN 9100:2009 (E)
3.4 Key characteristic
An attribute or feature whose variation has a significant effect on product form, fit, function,
performance, service life or producibility, that requires specific actions for the purpose of controlling
variation.
NOTE Special requirements and critical items are new terms and, along with key characteristics, are
interrelated. Special requirements are identified when determining and reviewing requirements related to the
product (see 7.2.1 and 7.2.2). Special requirements can require the identification of critical items. Design output
(see 7.3.3) can include identification of critical items that require specific actions to ensure they are adequately
managed. Some critical items will be further classified as key characteristics because their variation needs to be
controlled.
4 QUALITY MANAGEMENT SYSTEM
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and
co
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