SIST EN 9120:2010
(Main)Quality Management Systems - Requirements for Aviation, Space and Defence Distributors
Quality Management Systems - Requirements for Aviation, Space and Defence Distributors
This European 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.
Qualitätsmanagementsysteme - Anforderungen für Händler und Lagerhalter der Luftfahrt, Raumfahrt und Verteidigung
Diese Norm enthält die Anforderungen an das Qualitätsmanagementsystem nach ISO 9001:20081) und
legt zusätzliche 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 Europäische 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 die zutreffenden gesetzlichen und behördlichen Anforderungen erfüllen, und
b) danach strebt, die Kundenzufriedenheit durch 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 Europäischen 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 pour les distributeurs en aéronautique, spatial et défense
Sistemi vodenja kakovosti - Zahteve za distributerje na področju zračnega prometa, vesoljskih poletov in obrambe
Ta evropski standard določa zahteve za sistem vodenja kakovosti, kjer: a) mora organizacija prikazati svojo sposobnost dosledno zagotavljati proizvode, ki izpolnjujejo zahteve kupcev in veljavne zakone in predpise; in b) skuša organizacija krepiti zadovoljstvo kupcev s pomočjo učinkovite uporabe sistema, vključno s postopki za nenehno izboljševanje sistema in zagotavljanje skladnosti z zahtevami kupcev in veljavnimi zakoni in predpisi.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9120:2010
01-september-2010
1DGRPHãþD
SIST EN 9120:2008
6LVWHPLYRGHQMDNDNRYRVWL=DKWHYH]DGLVWULEXWHUMHQDSRGURþMX]UDþQHJD
SURPHWDYHVROMVNLKSROHWRYLQREUDPEH
Quality Management Systems - Requirements for Aviation, Space and Defence
Distributors
Qualitätsmanagementsysteme - Anforderungen für Händler und Lagerhalter der
Luftfahrt, Raumfahrt und Verteidigung
Systèmes de management de la Qualité - Exigences pour les distributeurs en
aéronautique, spatial et défense
Ta slovenski standard je istoveten z: EN 9120:2010
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
95.020 Vojaška tehnika. Vojaške Military engineering. Military
zadeve. Orožje affairs. Weapons
SIST EN 9120:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9120:2010
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SIST EN 9120:2010
EUROPEAN STANDARD
EN 9120
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2010
ICS 03.120.10; 49.020; 95.020 Supersedes EN 9120:2005
English Version
Quality Management Systems - Requirements for Aviation,
Space and Defence Distributors
Systèmes de management de la Qualité - Exigences pour Qualitätsmanagementsysteme - Anforderungen für Händler
les distributeurs en aéronautique, spatial et défense und Lagerhalter der Luftfahrt, Raumfahrt und Verteidigung
This European Standard was approved by CEN on 11 March 2010.
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, Croatia, 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9120:2010: E
worldwide for CEN national Members.
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SIST EN 9120:2010
EN 9120:2010 (E)
Contents Page
Foreword .4
FOREWORD .5
REVISION SUMMARY/RATIONALE .5
0 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
3.1 Airworthiness certificate .9
3.2 Certificate of conformity .9
3.3 Counterfeit part .9
3.4 Distributor .9
3.5 Risk .9
3.6 Splitting . 10
3.7 Suspected unapproved part . 10
3.8 Test report . 10
4 QUALITY MANAGEMENT SYSTEM. 10
4.1 General requirements . 10
4.2 Documentation Requirements . 11
4.2.1 General . 11
4.2.2 Quality Manual . 11
4.2.3 Control of Documents . 12
4.2.4 Control of Records . 12
5 MANAGEMENT RESPONSIBILITY . 13
5.1 Management Commitment . 13
5.2 Customer Focus . 13
5.3 Quality Policy . 13
5.4 Planning . 13
5.4.1 Quality Objectives . 13
5.4.2 Quality Management System Planning . 13
5.5 Responsibility, Authority and Communication . 14
5.5.1 Responsibility and Authority . 14
5.5.2 Management Representative . 14
5.5.3 Internal Communication . 14
5.6 Management Review . 14
5.6.1 General . 14
5.6.2 Review Input . 14
5.6.3 Review Output . 15
6 RESOURCE MANAGEMENT . 15
6.1 Provision of Resources . 15
6.2 Human Resources . 15
6.2.1 General . 15
6.2.2 Competence, Training and Awareness . 15
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6.3 Infrastructure . 16
6.4 Work Environment . 16
7 PRODUCT REALIZATION . 16
7.1 Planning of Product Realization . 16
7.1.1 Configuration Management. 16
7.1.2 Control of work transfers . 17
7.2 Customer related processes . 17
7.2.1 Determination of requirements related to the product . 17
7.2.2 Review of Requirements Related to the Product . 17
7.2.3 Customer Communication . 18
7.3 Design and Development . 18
7.4 Purchasing . 18
7.4.1 Purchasing Process . 18
7.4.2 Purchasing Information . 19
7.4.3 Verification of Purchased Product . 19
7.5 Production and Service Provision . 20
7.5.1 Control of Production and Service Provision . 20
7.5.2 Validation of Processes for Production and Service Provision . 20
7.5.4 Customer Property . 21
7.5.5 Preservation of Product . 21
7.6 Control of Monitoring and Measuring Equipment . 22
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT . 22
8.1 General . 22
8.2 Monitoring and Measurement . 23
8.2.1 Customer Satisfaction . 23
8.2.2 Internal Audit . 23
8.2.3 Monitoring and Measurement of Processes . 23
8.2.4 Monitoring and Measurement of Product . 24
8.2.5 Evidence of conformity . 24
8.3 Control of Nonconforming Product . 25
8.4 Analysis of Data . 26
8.5 Improvement . 26
8.5.1 Continual Improvement . 26
8.5.2 Corrective Action . 26
8.5.3 Preventive Action . 27
BIBLIOGRAPHY . 28
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SIST EN 9120:2010
EN 9120:2010 (E)
Foreword
This document (EN 9120:2010) 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 December 2010, and conflicting national standards shall be withdrawn
at the latest by December 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 9120:2005.
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, 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 9120:2010
EN 9120:2010 (E)
FOREWORD
To assure customer satisfaction, aviation and defense 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 defense industry, organizations providing maintenance, repair and overhaul
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.
REVISION SUMMARY/RATIONALE
This standard has been revised to incorporate the requirements of ISO 9001:2008 and IAQG developed
9100:2009. In addition, industry requirements, definitions and notes have been revised and additional
requirements have been included in response to stakeholder needs.
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SIST EN 9120:2010
EN 9120:2010 (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 European Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
The quality management system requirements specified in this European Standard are complementary to
requirements for products. Information marked "NOTE" is for guidance in understanding or clarifying the
associated requirement.
This European 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 European Standard.
0.2 Process approach
This European 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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EN 9120:2010 (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 European 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
analysis and Satisfaction
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 9120:2010
EN 9120:2010 (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 European 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 European 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 European 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 European 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 European 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 for use by organizations that procure parts, materials and assemblies and resells
these products to a customer in the aviation, space and defense industries. This includes
organizations that procure products and split them into smaller quantities including those that
coordinate a customer controlled service on the product. This standard is not intended for
organizations that maintain or repair products. Organizations that perform work that affect or could
affect product characteristics or conformity should use the IAQG-developed 9100 or 9110 standards,
as appropriate (see Bibliography).
1) With the permission of the International Organization for Standardization (ISO). The complete standard may 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. Copyright remains with ISO.
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EN 9120:2010 (E)
Requirements for the aviation, space and defence industries are specified in this standard.
Compliance to this standard means the expected exclusions for distributors are already taken for the
ISO 9001:2008 standard unless otherwise specified by the organization.
The following ISO 9001:2008 clauses are excluded in their entirety for purposes of this standard:
− 7.3 Design and development;
− 7.5.2 Validation of processes for production and service provision.
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.
EN ISO 9000:2005, Quality management systems — Fundamentals and vocabulary (ISO 9000:2005)
3 Terms and definitions
For the purposes of this European Standard, the terms and definitions given in EN ISO 9000:2005 apply.
Throughout the text of this European Standard, wherever the term "product" occurs, it can also mean
"service".
For the purpose of this standard, the term manufacturer is intentionally used to clearly delineate the
relationship between the product creator and the organization. The terms supplier, manufacturer and
product creator may be synonymous.
supplier →→→→ organization →→→→ customer
(manufacturer/product creator)
3.1 Airworthiness certificate
A document issued by the cognizant civil aviation authority (e.g. EASA Form 1, FAA Form 8130-3) that
certifies that the part conforms to the applicable regulatory requirements.
3.2 Certificate of conformity
A document that certifies product conformity to process, design and/or specification requirements;
commonly referred to as a "Certificate of Conformance".
3.3 Counterfeit part
A product produced or altered to imitate or resemble a product without authority or right to do so,
with the intent to mislead or defraud by passing the imitation as original or genuine.
3.4 Distributor
Organization carrying out the purchase, storage, splitting or sale of products without affecting
product conformity. The term organization in the context of this standard means a distributor.
3.5 Risk
An undesirable situation or circumstance that has both a likelihood of occurring and a potentially
negative consequence.
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EN 9120:2010 (E)
3.6 Splitting
The division of product either physically or by batch quantity, without affecting the product
characteristics.
3.7 Suspected unapproved part
A product that might not have been or is suspected of not having been produced in accordance with
applicable laws and regulations.
3.8 Test report
Objective evidence provided by either the manufacturer or a certified testing facility that the product
conforms with specific design requirements or properties.
4 QUALITY MANAGEMENT SYSTEM
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements of this European Standard.
The organization's quality management system shall also address customer and applicable statutory
and regulatory quality management system requirements.
The organization shall:
a) determine the proc
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