SIST EN 9120:2008
(Main)Aerospace series - Quality management systems - Requirements for stockist distributors (based on ISO 9001:2000)
Aerospace series - Quality management systems - Requirements for stockist distributors (based on ISO 9001:2000)
This standard includes ISO 9001:2000 quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry applicable to stockist distributors. The additional aerospace requirements are shown in bold, italic text.
It is emphasized that the quality management system requirements specified in this standard are complementary (not alternative) to contractual and applicable law and regulatory requirements.
This 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 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 regulatory requirements.
NOTE In this Standard, the term "product" applies only to the product intended for, or required by, a customer.
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Anforderungen an Händler und Lagerhalter (basiert auf ISO 9001:2000)
Diese Norm enthält Anforderungen an Qualitätsmanagementsysteme gemäß ISO 9001:2000 ) und legt zusätzliche Anforderungen an Qualitätsmanagementsysteme für die Luft- und Raumfahrtindustrie fest, die für Händler und Lagerhalter anwendbar sind. Die zusätzlichen Luft- und Raumfahrtanforde¬rungen sind fett und kursiv gedruckt.
Es wird darauf hingewiesen, dass die in dieser Norm festgelegten Anforderungen an Qualitäts¬managementsysteme ergänzend (nicht alternativ) zu den vertraglichen, gesetzlichen und behördlichen Anforderungen sind.
Diese 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 behördlichen Anforderungen erfüllen, und
b) danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, ein¬schließlich der Prozesse zur ständigen Verbesserung des Systems und Zusicherung der Einhaltung der Anforderungen der Kunden und der zutreffenden behördlichen Anforderungen.
ANMERKUNG In dieser Norm bezieht sich die Benennung „Produkt“ nur auf Produkte, die für einen Kunden vorge¬sehen sind oder von diesem gefordert werden.
Série aérospatiale - Systèmes de management de la qualité - Exigences pour les distributeurs stockistes (basé sur ISO 9001:2000)
Aeronavtika - Sistemi vodenja kakovosti - Zahteve za distributerje skladiščnike (na podlagi ISO 9001:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9120:2008
01-junij-2008
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QDSRGODJL,62
Aerospace series - Quality management systems - Requirements for stockist distributors
(based on ISO 9001:2000)
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Anforderungen an Händler und
Lagerhalter (basiert auf ISO 9001:2000)
Série aérospatiale - Systèmes de management de la qualité - Exigences pour les
distributeurs stockistes (basé sur ISO 9001:2000)
Ta slovenski standard je istoveten z: EN 9120:2005
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 9120:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN 9120
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2005
ICS 03.120.10; 49.020
English Version
Aerospace series - Quality management systems -
Requirements for stockist distributors (based on ISO 9001:2000)
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsystems -
qualité - Exigences pour les distributeurs stockistes (basé Anforderungen für Händler und Lagerhalter (basiert auf ISO
sur ISO 9001:2000) 9001:2000)
This European Standard was approved by CEN on 28 October 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9120:2005: E
worldwide for CEN national Members.
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EN 9120:2005 (E)
Contents Page
Introduction.5
0.1 General.5
0.1 Process approach.5
1 Scope.7
1.1 General.7
1.2 Application.7
2 Normative references.7
3 Terms and definitions.8
4 Quality management system.8
4.1 General requirements.8
4.2 Documentation requirements.9
4.2.1 General.9
4.2.2 Quality manual.9
4.2.3 Control of documents.10
4.2.4 Control of records.10
5 Management responsibility.11
5.1 Management commitment.11
5.2 Customer focus.11
5.3 Quality policy.11
5.4 Planning.11
5.4.1 Quality objectives.11
5.4.2 Quality management system planning .11
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.12
5.6 Management review.12
5.6.1 General.12
5.6.2 Review input.12
5.6.3 Review output.13
6 Resource management.13
6.1 Provision of resources.13
6.2 Human resources.13
6.2.1 General.13
6.2.2 Competence, awareness and training.13
6.3 Infrastructure.13
6.4 Work environment.13
7 Product realization.14
7.1 Planning of product realization.14
7.2 Customer-related processes.14
7.2.1 Determination of requirements related to the product .14
7.2.2 Review of requirements related to the product.14
7.2.3 Customer communication.14
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EN 9120:2005 (E)
7.3 Design and development.15
7.4 Purchasing.15
7.4.1 Purchasing process.15
7.4.2 Purchasing information.15
7.4.3 Verification of purchased product.16
7.5 Production and service provision .16
7.5.1 Control of production and service provision .16
7.5.2 Validation of processes for production and service provision.16
7.5.3 Identification and traceability.16
7.5.4 Customer property.17
7.5.5 Preservation of product.17
7.6 Control of monitoring and measuring devices.17
8 Measurement, analysis and improvement .18
8.1 General.18
8.2 Monitoring and measurement.19
8.2.1 Customer satisfaction.19
8.2.2 Internal audit.19
8.2.3 Monitoring and measurement of processes .19
8.2.4 Monitoring and measurement of product.19
8.2.5 Evidence of conformance - Certificate of conformity .20
8.3 Control of nonconforming product.20
8.4 Analysis of data .21
8.5 Improvement.22
8.5.1 Continual improvement.22
8.5.2 Corrective action.22
8.5.3 Preventive action.22
Bibliography.23
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EN 9120:2005 (E)
Foreword
This European Standard (EN 9120:2005) has been prepared by the European Association of Aerospace
Manufacturers - Standardization (AECMA-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
AECMA, 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 June 2006, and conflicting national standards shall be withdrawn at
the latest by June 2006.
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.
In December 1998, the Aerospace Industry established the International Aerospace Quality Group (IAQG)
with the purpose of achieving significant improvements in quality and reductions in cost throughout the value
stream.
This organization, with representation from Aerospace companies in Americas, Asia and Europe and sponsored
by SAE, SJAC and AECMA has agreed to take responsibility for the technical contents of this standard.
This standard was reviewed by the Domain Technical Coordinator of AECMA-STAN's Process Domain.
To assure customer satisfaction, aerospace industry organizations must produce, and continually
improve, safe, reliable products that meet or exceed customer and regulatory agency requirements.
The globalization of the aerospace industry, and the resulting diversity of regional/national
requirements and expectations, has complicated this objective. End-product organizations face the
challenge of assuring the quality of, and integrating, product purchased from suppliers throughout
the world and at all levels within the supply chain. Aerospace suppliers and processors face the
challenge of delivering product to multiple customers having varying quality expectations and
requirements.
This document standardizes, to the greatest extent possible, quality management system
requirements for the aerospace industry. The establishment of common requirements, for use at all
levels of the supply-chain, by organizations around the world, should result in improved quality and
safety, and decreased costs, due to the elimination or reduction of organization-unique requirements
and the resultant variation inherent in these multiple expectations.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and the United Kingdom.
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EN 9120:2005 (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 varying needs, particular
objectives, the products provided, the processes employed and the size and structure of the organization. It is
not the intent of this Standard to imply uniformity in the structure of quality management systems or uniformity
of documentation.
The quality management system requirements specified in this Standard are complementary to requirements
for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated
requirement.
This Standard can be used by internal and external parties, including certification bodies, to assess the
organization's ability to meet customer, regulatory 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 Standard.
0.2 Process approach
This 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 identify and manage numerous linked activities. An activity
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, 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,
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 Standard, but does not show processes at a detailed level.
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EN 9120:2005 (E)
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
Customers
Management
responsibility
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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EN 9120:2005 (E)
1 Scope
1.1 General
1)
This standard includes ISO 9001:2000 quality management system requirements and specifies
additional requirements for a quality management system for the aerospace industry applicable to
stockist distributors. The additional aerospace requirements are shown in bold, italic text.
It is emphasized that the quality management system requirements specified in this standard are
complementary (not alternative) to contractual and applicable law and regulatory requirements.
This 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
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 regulatory requirements.
NOTE In this Standard, the term “product” applies only to the product intended for, or required by, a customer.
1.2 Application
All requirements of this 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 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 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 regulatory requirements.
This standard is for use by organizations that procure parts, materials and assemblies and sells these
products to a customer in the aerospace industry. This includes organizations that procure products
and split them into smaller quantities. This standard is not intended for organizations that rework or
repair products. Organizations that perform work that affect or could affect product characteristics or
conformity shall use EN 9100 or another quality management system standard.
The following ISO 9001:2000 clauses are excluded in their entirety for purposes of the EN 9120
requirements for stockist distributors: 7.1, 7.3, and 7.5.2.
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 9000:2000, Quality management systems — Fundamentals and vocabulary.
ISO 9001:2000, Quality management systems – Requirements.
EN 9100:2001, Aerospace series – Quality management systems – Requirements (based on ISO 9001:2000).
2)
EN 9130:2000, Aerospace series – Quality systems – Record retention.
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, Case Postale 56, 1211 Geneva 20, Switzerland.
Copyright remains with ISO.
2) Published as AECMA Prestandard at the date of publication of this standard.
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EN 9120:2005 (E)
3 Terms and definitions
For the purposes of this Standard, the terms and definitions given in ISO 9000 apply.
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to
reflect the vocabulary currently used:
supplier →→ organization → customer
→→
manufacturer
For the purpose of this document, the term manufacturer is intentionally used to clearly delineate the
product creator.
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which
this Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Airworthiness Certificate: A document issued by the cognizant civil aviation authority (e.g., JAA
Form 1, FAA Form 8130-3) that certifies that the part has been manufactured, overhauled, or repaired
in accordance with, and conforms to, the applicable airworthiness regulations.
Manufacturer's Certificate/Test Report: A document issued by the product manufacturer that certifies
product conformance to process, design, and/or specification requirements.
Splitting:
- batch splitting - the separation of entities, such as sheets, bars, components, parts, fasteners,
and containers belonging to the same production batch.
- product splitting - physically dividing a solid entity such as bar, sheet, plate (metallic or non-
metallic material) or partial decanting of a gaseous or liquid entity, where the physical and
metallurgical properties or chemical characteristics are not altered.
Splitting shall not affect the conformance of the product as defined by the original product
specification.
Stockist Distributors: Organization carrying out the purchase, storage, splitting, and sale of products
without affecting product conformance. The term organization in the context of this standard means a
stockist distributor.
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 Standard.
The organization shall
a) identify the processes needed for the quality management system and their application throughout the
organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes
are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of
these processes,
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EN 9120:2005 (E)
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements,
the organization shall ensure control over such processes. Control of such outsourced processes shall be
identified within the quality management system.
NOTE Processes needed for the quality management system referred to above should include processes for
management activities, provision of resources, product realization and measurement.
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its
processes,
e) records required by this Standard (see 4.2.4), and
f) quality system requirements imposed by the applicable regulatory authorities.
The organization shall ensure that personnel have access to quality management system
documentation and are aware of relevant procedures. Customer and/or regulatory authorities
representatives shall have access to quality management system documentation.
NOTE 1 Where the term “documented procedure” appears within this Standard, this means that the procedure is
established, documented, implemented and maintained.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions
(see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
- when referencing the documented procedures, the relationship between the requirements of
this Standard and the documented procedures shall be clearly shown.
c) a description of the interaction between the processes of the quality management system.
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EN 9120:2005 (E)
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of
document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they
are retained for any pu
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