EN 9100:2003

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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
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
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
4.13.1 General.49
4.13.2 Review and disposition of nonconforming product.50
4.13.2.1 Material review authority .50
Regrading material
4.13.2.2 .50
4.13.2.3 Scrap material.50
4.13.2.4 Notification.50
4.14 Corrective and preventive action .51
4.14.1 General.51
4.14.2 Corrective action.51
4.14.3 Preventive action .51
4.15 Handling, storage, packaging, preservation and delivery.51
4.15.1 General.51
4.15.2 Handling.52
4.15.3 Storage.52
4.15.4 Packaging .52
4.15.5 Preservation .52
4.15.6 Delivery .52
4.16 Control of quality records .52
4.17 Internal quality audits.53
4.18 Training .53
4.19 Servicing .53
4.20 Statistical techniques .54
4.20.1 Identification of need.54
4.20.2 Procedures .54
Bibliography .55
Foreword
This document (EN 9100:2003) has been prepared by the European Association of Aerospace Industries –
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 November 2003, and conflicting national standards shall be withdrawn at the latest
by November 2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
General
To assure customer satisfaction, aerospace industry organizations must produce, and continually improve, safe,
reliable products that meet or exceed customer and regulatory authority 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.
Structure and Application
This standard includes aerospace requirements applied to, and integrated with, both the ISO 9001: 2000 and the
ISO 9001: 1994 quality management system models. The section of this standard that shall apply is determined by
the organization's current quality management system (QMS) status in regards to alignment/compliance with ISO
9001.
Organizations now having a QMS based on ISO 9001: 1994, that are expanding the scope of their QMS to include
EN 9100 requirements, shall utilize the section of this standard aligned with ISO 9001: 1994. Upon transition to an
ISO 9001: 2000-based QMS, organizations shall use the section of this standard aligned with ISO 9001: 2000. In
accordance with the time period established for organizations to transition from ISO 9001: 1994 to ISO 9001: 2000,
the section of this standard based on the ISO 9001: 1994 model will be withdrawn on December 15, 2003.
Organizations initially developing an ISO 9001/EN 9100-based QMS after December 15, 2000 must develop a
QMS based on ISO 9001:2000 and shall utilize the section of this standard that is based on ISO 9001: 2000.
The ISO 9001 model, and the corresponding EN 9100 section, that is deployed shall be declared in the
organization's quality manual.
NOTE This standard is technically equivalent to SAE AS9100
SECTION 1
***
QUALITY MANAGEMENT SYSTEMS
REQUIREMENTS
(based on ISO 9001:2000)
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 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 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





 

requirement.
This International 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 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 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




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 International Standard, but does not show processes at a detailed level.
NOTE In addition, the methodology known as


 !

!
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
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS
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. 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








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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 regulatory requirements.
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent edition of the normative document indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO (International
Organization for Standardization) and IEC (International Electrotechnical Commission) maintain registers of
currently valid International Standards.
ISO 9000: 2000 Quality management systems – Fundamentals and vocabulary
ISO 9001: 2000 Quality management systems – Requirements
EN 9130: 2000 Aerospace series – Quality systems – Record retention

) 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.
...