EN 9100:2003
(Main)Aerospace series - Quality management systems - Requirements (based on ISO 9001:2000) and Quality systems - Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994)
Aerospace series - Quality management systems - Requirements (based on ISO 9001:2000) and Quality systems - Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994)
This standard includes ISO 9001: 2000 ) quality management system requirements and specifies additional requirements for a quality management system for the aerospace industry. 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 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 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 International Standard, the term ?product? applies only to the product intended for, or required by, a customer.
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Anforderungen (basiert auf ISO 9001:2000) und Qualitätsmanagementsysteme - Qualitätssicherungsmodelle für Konstruktion, Entwicklung, Produktion, Montage und Wartung (basiert auf ISO 9001:1994)
Diese Norm enthält die auf die Modelle zum Qualitätsmanagementsystem nach ISO 9001:2000 und ISO 9001:1994 angewandten und in diese integrierten Anforderungen der Luft- und Raumfahrt. Welcher Hauptabschnitt dieser Norm anzuwenden ist, richtet sich nach dem derzeitigen Qualitätsmanagementsystemstatus der Organisation, was die Abgleichung/Überein-stimmung mit ISO 9001 anbelangt.
Organisationen, die derzeit ein Qualitätsmanagementsystem nach ISO 9001:1994 verwenden und den Anwendungsbereich ihres Qualitätsmanagementsystems durch Einbeziehung der Anforderungen von EN 9100 erweitern wollen, müssen den mit ISO 9001:1994 abgestimmten Hauptabschnitt dieser Norm verwenden. Nach Übergang auf ein Qualitätsmanagementsystem nach ISO 9001:2000 müssen die Organisationen den mit ISO 9001:2000 abgestimmten Hauptabschnitt der vorliegenden Norm verwenden. In Übereinstimmung mit der für den Übergang der Organisationen von ISO 9001:1994 zu ISO 9001:2000 festgelegten Frist, wird der Hauptabschnitt nach dem Modell von ISO 9001:1994 der vorliegenden Norm am 15. Dezember 2003 zurückgezogen.
Organisationen, die nach dem 15. Dezember 2000 zunächst ein Qualitätsmanagement nach ISO 9001/EN 9100 erstellen, müssen ein Qualitätsmanagementsystem nach ISO 9001:2000 erstellen und den Hauptabschnitt dieser Norm nach ISO 9001:2000 verwenden.
Das Modell nach ISO 9001 und der jeweilig verwendete Hauptabschnitt von EN 9100 sind im Qualitätsmanagement-Handbuch der Organisation anzugeben.
ANMERKUNG Diese Norm ist technisch gleichwertig mit SAE AS9100.
Série aérospatiale - Systèmes de management de la Qualité - Exigences (basé sur ISO 9001:2000) - Systémes qualité - Modèle pour l'assurance qualité en conception, developpement, production, installation et exploitation (basé sur ISO 9001:1994)
1.1 Généralités
La présente norme comporte les exigences en matière de système de management de la qualité développées dans l'ISO 9001:2000 ) et spécifie des exigences supplémentaires en matière de système de management de la qualité de l'industrie aérospatiale. Les exigences supplémentaires sont indiquées par du texte en gras et en italique.
Il faut signaler que les exigences en matière de système de management de la qualité spécifiées dans la présente norme sont complémentaires aux exigences contractuelles, légales et réglementaires applicables, mais ne les remplacent pas.
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 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 Dans la présente Norme internationale, le terme "produit" s'applique uniquement au produit destiné à, ou exigé par, un client.
1.2 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'affectent pas l'aptitude de l'organisme à fournir un produit conforme aux exigences des clients et aux exigences réglementaires applicables, ni ne le dégagent de
Aerospace series - Quality management systems - Requirements (based on ISO 9001:2000) and Quality systems - Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9100:2004
01-maj-2004
Aerospace series - Quality management systems - Requirements (based on ISO
9001:2000) and Quality systems - Model for quality assurance in design,
development, production, installation and servicing (based on ISO 9001:1994)
Aerospace series - Quality management systems - Requirements (based on ISO
9001:2000) and Quality systems - Model for quality assurance in design, development,
production, installation and servicing (based on ISO 9001:1994)
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Anforderungen (basiert auf ISO
9001:2000) und Qualitätsmanagementsysteme - Qualitätssicherungsmodelle für
Konstruktion, Entwicklung, Produktion, Montage und Wartung (basiert auf ISO
9001:1994)
Série aérospatiale - Systemes de management de la Qualité - Exigences (basé sur ISO
9001:2000) - Systémes qualité - Modele pour l'assurance qualité en conception,
developpement, production, installation et exploitation (basé sur ISO 9001:1994)
Ta slovenski standard je istoveten z: EN 9100:2003
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 9100:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9100:2004
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SIST EN 9100:2004
EUROPEAN STANDARD
EN 9100
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2003
ICS 03.120.10; 49.020
English version
Aerospace series - Quality management systems -
Requirements (based on ISO 9001:2000) and Quality systems -
Model for quality assurance in design, development, production,
installation and servicing (based on ISO 9001:1994)
Série aérospatiale - Système de management de la Qualité Luft- und Raumfahrt - Qualitätsmanagementsysteme -
- Exigences (basé sur ISO 9001:2000) et Système qualité - Anforderungen (basiert auf ISO 9001:2000) und
Modèle pour l'assurance qualité en conception, Qualitätssysteme - Qualitätssicherungsmodelle für
développement, production, installation et exploitation Konstruktion, Entwicklung, Produktion, Montage und
(basé sur ISO 9001:1994) Wartung (basiert auf ISO 9001:1994)
This European Standard was approved by CEN on 14 February 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9100:2003 E
worldwide for CEN national Members.
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SIST EN 9100:2004
EN 9100:2003 (E)
Contents
Foreword. 6
Structure and Application . 7
SECTION 1: Quality management systems - Requirements (based on ISO 9001:2000). 8
0 Introduction . 9
0.1 General . 9
0.2 Process approach . 9
Quality management systems - Requirements . 11
1 Scope. 11
1.1 General . 11
1.2 Application. 11
2 Normative reference . 11
3 Terms and definitions. 12
4 Quality management system . 12
4.1 General requirements . 12
4.2 Documentation requirements . 13
4.2.1 General . 13
4.2.2 Quality manual. 13
4.2.3 Control of documents. 13
4.2.4 Control of records. 14
4.3 Configuration management . 14
5 Management responsibility. 14
5.1 Management commitment. 14
5.2 Customer focus. 14
5.3 Quality policy. 15
5.4 Planning . 15
5.4.1 Quality objectives. 15
5.4.2 Quality management system planning . 15
5.5 Responsibility, authority and communication. 15
5.5.1 Responsibility and authority. 15
5.5.2 Management representative. 15
5.5.3 Internal communication. 15
5.6 Management review . 16
5.6.1 General . 16
5.6.2 Review input . 16
5.6.3 Review output. 16
6 Resource management. 16
6.1 Provision of resources . 16
6.2 Human resources. 16
6.2.1 General . 16
6.2.2 Competence, awareness and training . 17
6.3 Infrastructure. 17
6.4 Work environment. 17
7 Product realization. 17
7.1 Planning of product realization . 17
7.2 Customer-related processes. 18
7.2.1 Determination of requirements related to the product. 18
7.2.2 Review of requirements related to the product . 18
7.2.3 Customer communication. 18
7.3 Design and development. 18
2
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7.3.1 Design and development planning .18
7.3.2 Design and development inputs.19
7.3.3 Design and development outputs .20
7.3.4 Design and development review .20
7.3.5 Design and development verification .20
7.3.6 Design and development validation.21
7.3.6.1 Documentation of design and/or development verification and validation .21
7.3.6.2 Design and/or development verification and validation testing.21
7.3.7 Control of design and development changes.21
7.4 Purchasing.21
7.4.1 Purchasing process.21
7.4.2 Purchasing information.22
7.4.3 Verification of purchased product .23
7.5 Production and service provision.23
7.5.1 Control of production and service provision.23
Production documentation
7.5.1.1 .24
7.5.1.2 Control of production process changes.24
7.5.1.3 Control of production equipment, tools and Numerical Control (N.C.) machine programs.24
7.5.1.4 Control of work transferred, on a temporary basis, outside the organization’s facilities .25
7.5.1.5 Control of service operations .25
7.5.2 Validation of processes for production and service provision.25
7.5.3 Identification and traceability .25
7.5.4 Customer property.26
7.5.5 Preservation of product .26
7.6 Control of monitoring and measuring devices .26
8 Measurement, analysis and improvement .27
8.1 General.27
8.2 Monitoring and measurement.28
8.2.1 Customer satisfaction .28
8.2.2 Internal audit.28
8.2.3 Monitoring and measurement of processes .28
8.2.4 Monitoring and measurement of product.29
8.2.4.1 Inspection documentation.29
First article inspection
8.2.4.2 .29
8.3 Control of nonconforming product.29
8.4 Analysis of data.30
8.5 Improvement.31
8.5.1 Continual improvement.31
8.5.2 Corrective action.31
8.5.3 Preventive action .31
Bibliography .32
SECTION 2: Quality systems –Model for Quality Assurance in design, development,
production, installation and servicing (based on ISO 9001:1994) .33
Quality systems –Model for Quality Assurance in design, development, production, installation and
servicing .34
1 Scope.34
2 Normative reference .34
3 Definitions.34
3.1 Product.34
3.2 Tender .35
3.3 Contract .35
3.4 Key characteristics .35
4 Quality system requirements.35
4.1 Management responsibility.35
4.1.1 Quality policy.35
4.1.2 Organization .35
4.1.2.1 Responsibility and authority .35
3
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4.1.2.2 Resources . 35
4.1.2.3 Management representative. 35
4.1.2.4 Process performer. 36
4.1.3 Management review . 36
4.2 Quality system. 36
4.2.1 General . 36
4.2.2 Quality system procedures. 36
4.2.3 Quality planning . 37
4.2.4 Configuration management . 37
4.3 Contract review . 37
4.3.1 General . 37
4.3.2 Review. 38
4.3.3 Amendment to a contract. 38
4.3.4 Records . 38
4.4 Design control . 38
4.4.1 General . 38
4.4.2 Design and development planning. 38
4.4.2.1 Design and development management planning. 38
4.4.2.2 Reliability, maintainability, safety. 39
4.4.3 Organizational and technical interfaces . 39
4.4.4 Design input. 39
4.4.5 Design output . 39
4.4.6 Design review . 39
4.4.7 Design verification . 40
4.4.8 Design validation. 40
4.4.8.1 Documentation of design verification and validation. 40
4.4.8.2 Design verification and validation testing . 40
4.4.9 Design changes. 41
4.5 Document and data control. 41
4.5.1 General . 41
4.5.2 Document and data approval and issue . 41
4.5.3 Document and data changes . 41
4.6 Purchasing. 42
4.6.1 General . 42
4.6.2 Evaluation of subcontractors . 42
4.6.3 Purchasing data . 42
4.6.4 Verification of purchased product. 43
4.6.4.1 Supplier verification at subcontractor’s premises. 43
4.6.4.2 Customer verification of subcontracted product. 43
4.7 Control of customer-supplied product . 43
4.8 Product identification and traceability. 44
4.9 Process control . 44
4.9.1 General. 44
4.9.1.1 Production documentation. 45
4.9.1.2 Control of production process changes . 45
Control of production equipment, tools and Numerical Control (N.C.) machine programs
4.9.1.3 . 45
4.9.1.4 Control of work occasionally performed outside the supplier’s facilities . 45
4.9.2 Special processes. 45
4.10 Inspection and testing . 46
4.10.1 General . 46
4.10.2 Receiving inspection and testing. 46
4.10.3 In-process inspection and testing. 47
4.10.4 Final inspection and testing. 47
4.10.5 Inspection and test records . 47
4.10.6 First article inspection.47
4.11 Control of inspection, measuring and test equipment. 48
4.11.1 General . 48
4.11.2 Control procedure. 48
4.12 Inspection and test status. 49
4.12.1 Authorized personnel . 49
4.12.2 Acceptance authority media . 49
4.13 Control of nonconforming product . 49
4
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4.13.1 General.
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