SIST EN 9107:2019
(Main)Aerospace series - Quality systems - Direct Delivery Authorization - Guidance for Aerospace Companies
Aerospace series - Quality systems - Direct Delivery Authorization - Guidance for Aerospace Companies
1.1 General
Limited to the commercial aerospace industry where a request is made for a PO to have Direct Delivery Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design Organisation (DO). In this process the DO is responsible for ensuring the continuous updating of design and airworthiness data to the PO, whilst the PO is responsible for assurance that the manufactured article conforms to approved design and airworthiness data. The PO is responsible to provide airworthiness release documentation.
1.2 Purpose
This document provides guidance to a PO and DO on how to comply with the DDA, including AA requirements per the applicable documents referenced in Clause 2 (see Figure 1).
(...)
Luft- und Raumfahrt - Qualitätsmanagement - Autorisierung für Direktanlieferungen - Richtlinie für die Luft- und Raumfahrtindustrie
Série Aérospatiale - Systèmes qualité - Autorisation de livraison directe - Recommandations pour les compagnies aérospatiales
Aeronavtika - Sistemi vodenja kakovosti - Dovoljenje za neposredno dostavo - Navodilo za letalsko in vesoljsko industrijo
1.1 Splošno
Standard je omejen na komercialno letalsko in vesoljsko industrijo, kjer se zahteva, da ima proizvajalec (PO) dovoljenje za neposredno dostavo (DDA), ki vključuje ustrezen dogovor (AA) med proizvajalcem in projektno organizacijo (DO). V tem procesu mora projektna organizacija (DO) zagotavljati proizvajalcu stalno posodobljene podatke o projektiranju in plovnosti, medtem ko mora proizvajalec zagotavljati, da je proizvedeni izdelek skladen z odobrenimi podatki o projektiranju in plovnosti. Proizvajalec je dolžen zagotoviti dokumentacijo o potrditvi plovnosti.
1.2 Namen
Ta dokument proizvajalcu in projektni organizaciji zagotavlja smernice, kako ravnati v skladu z dovoljenjem za neposredno dostavo, vključno z zahtevami ustrezne ureditve glede na veljavne dokumente iz točke 2 (glej sliko 1).
(...)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9107:2019
01-marec-2019
Aeronavtika - Sistemi vodenja kakovosti - Dovoljenje za neposredno dostavo -
Navodilo za letalsko in vesoljsko industrijo
Aerospace series - Quality systems - Direct Delivery Authorization - Guidance for
Aerospace Companies
Luft- und Raumfahrt - Qualitätsmanagement - Autorisierung für Direktanlieferungen -
Richtlinie für die Luft- und Raumfahrtindustrie
Série Aérospatiale - Systèmes qualité - Autorisation de livraison directe -
Recommandations pour les compagnies aérospatiales
Ta slovenski standard je istoveten z: EN 9107:2018
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 9107:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9107:2019
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SIST EN 9107:2019
EN 9107
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 03.120.10; 49.020
English Version
Aerospace series - Quality systems - Direct Delivery
Authorization - Guidance for Aerospace Companies
Série Aérospatiale - Systèmes qualité - Autorisation de Luft- und Raumfahrt - Qualitätsmanagement -
livraison directe - Recommandations pour les Autorisierung für Direktanlieferungen - Richtlinie für
compagnies aérospatiales die Luft- und Raumfahrtindustrie
This European Standard was approved by CEN on 11 June 2018.
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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9107:2018 E
worldwide for CEN national Members.
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SIST EN 9107:2019
EN 9107:2018 (E)
Contents
Page
European foreword . 3
Rationale . 4
Foreword . 4
1 Scope . 5
2 Applicable documents . 6
3 Terms and definitions . 6
4 Direct delivery authorization requirements. 8
(informative) Acronym log . 11
(informative) Appropriate arrangement . 12
(informative) Direct delivery authorization template . 16
(informative) Article listing . 18
Figures
Figure 1 — Direct delivery overview. 5
Figure 2 — Direct delivery authorization process flow . 8
2
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SIST EN 9107:2019
EN 9107:2018 (E)
European foreword
This document (EN 9107:2018) 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 document 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 document shall be given the status of a national standard, either by publication of an identical text
or by endorsement, at the latest by June 2019, and conflicting national standards shall be withdrawn at
the latest by June 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
3
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SIST EN 9107:2019
EN 9107:2018 (E)
Rationale
This document was revised to coincide with European Union (EU) Commission Regulation
rd
No. 748/2012 of 3 August 2012 as amended by EU Commission Regulations No. 7/2013 of
th th
8 January 2013 and No. 69/2014 of 27 January 2014, and the associated Acceptable Means of
Compliance (AMC) and Guidance Material (GM) to Part 21 of EU Commission Regulation No. 748/2012.
All other changes made to the document presented herein were editorial in nature.
Foreword
To assure customer satisfaction, the aviation, space, and defence industry organisations must produce
and continually improve safe, reliable products that meet or exceed customer and regulatory authority
requirements. The globalization of the industry, and the resulting diversity of regional/national
requirements and expectations, has complicated this objective. End-product organisations 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. Industry suppliers and processors face the challenge of
delivering product to multiple customers having varying quality expectations and requirements.
The aviation, space, and defence industry established the International Aerospace Quality Group (IAQG)
for the purpose of achieving significant improvements in quality and safety, and reductions in cost,
throughout the value stream. This organisation includes representation from companies in the
Americas, Asia/Pacific, and Europe.
This document standardizes requirements for the “direct delivery” of articles from a Production
Organisation (PO); it was originally produced as a cooperative effort between the European Aviation
Safety Agency (EASA) and the IAQG. The establishment of common expectations, for use at all levels of
the supply-chain by organisations, should result in improved quality and safety, and decreased costs,
due to the elimination or reduction of organisation-unique requirements and the resultant variation
inherent in these multiple expectations.
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SIST EN 9107:2019
EN 9107:2018 (E)
1 Scope
1.1 General
Limited to the commercial aerospace industry where a request is made for a PO to have Direct Delivery
Authorization (DDA), which includes an Appropriate Arrangement (AA) between the PO and the Design
Organisation (DO). In this process the DO is responsible for ensuring the continuous updating of design
and airworthiness data to the PO, whilst the PO is responsible for assurance that the manufactured
article conforms to approved design and airworthiness data. The PO is responsible to provide
airworthiness release documentation.
1.2 Purpose
This document provides guidance to a PO and DO on how to comply with the DDA, including AA
requirements per the applicable documents referenced in Clause 2 (see Figure 1).
Key
A/W Airworthiness release documentation
Figure 1 — Direct delivery overview
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EN 9107:2018 (E)
2 Applicable documents
These include, but are not limited to.
2.1 European Aviation Safety Agency publications
a) EU Commission Regulation No. 748/2012, Annex I, Subpart G — Production Organisation Approval,
Part 21.A.133, Eligibility, paragraph (c)
b) EU Commission Regulation No. 748/2012, Annex I, Subpart G — Production Organisation Approval,
Part 21.A.165, Obligations of the holder
c) Acceptable Means of Compliance (AMC) 21.A.4, Transferring of information on eligibility and
approval status from the design holder to production organisations
d) AMC No. 1 to 21.A.133(b) and (c), Eligibility — Link between design and production organisations
e) AMC No. 2 to 21.A.133(b) and (c), Eligibility — Link between design and production organisations
2.2 Federal Aviation Administration publications
a) 14 Code of Federal Regulations (CFR) Part 21, Certification Procedures for Products, Articles, Parts
2.3 Transport Canada publications
a) Canadian Aviation Regulations (CARs) Part V — Airworthiness
3 Terms and definitions
For the purposes of this document, the following terms and definitions given in Annex A and the
following apply.
3.1
Appropriate Arrangement
AA
documented link between a DO and PO that describes the required coordination necessary to ensure
airworthiness data and continuing airworthiness matters is satisfactory, and meets regulatory authority
requirements
3.2
approved application
designation of the product, part, appliance, etc. having design and airworthiness data approval by a
regulatory authority for which an article is eligible for installation
3.3
approved design and airworthiness data
after issuance of the Type Certificate (TC), Supplemental Type Certificate (STC), Parts Manufacturer
Approval (PMA), Technical Standard Order (TSO)/Joint Technical Standard Order (JTSO)/European
Technical Standard Order (ETSO) Authorization or equivalent by the regulatory authority, design and
airworthiness data is defined as “approved”; Items manufactured in conformity to this data are eligible
to be released using Authorised/Authorized Release Certificates (ARCs) certifying airworthiness
Note 1 to entry: The approved design and airworthiness data typically consists of drawings, material
specifications, dimensional data, processes, surface treatments, shipping conditions, quality requirements, etc.
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3.4
article
material, part, product, component, assembly, or appliance which is listed by the DO as eligible for
installation in a type-certificated product or included in the design and airworthiness data approved by
the regulatory authority; not inclusive of standard parts
3.5
Authorised/Authorized Release Certificate
ARC
document whose purpose is to detail an aeronautical product which has been manufactured or
maintained, the data to which it conforms or was maintained to, and who manufactured or performed
the maintenance on it; in Canada, this document is known as the Transport Canada Authorized Release
Certificate – Form One; in the EASA system, it is known as the EASA Form 1; and the Federal Aviation
Administration (FAA) equivalent is the FAA Form 8130-3
3.6
constituent
part, component, or element of a larger unit/installation/assembly
3.7
Design Organisation
DO
organisation responsible for the design of articles or for changes thereto that is the holder of a design
approval granted by a regulatory authority (i.e., TC, STC, PMA, TSO/JTSO/ETSO Authorization, or
equivalent)
3.8
Direct Delivery Authorization
DDA
written endorsement granted by a DO to a PO that allows the PO to deliver articles to end-users,
installers, or customers; and for this purpose to use the DO’s approved design and airworthiness data to
declare an article in conformance to the regulatory approved data in order to guarantee continued
airworthiness control of the released articles
3.9
product
aircraft, aircraft engine, or propeller
3.10
Production Organisation
PO
organisation, approved by an applicable regulatory authority, which is responsible for the manufacture
of aeronautical articles
3.11
standard part
parts for which the design, manufacturing, inspection data, and marking requirements necessary to
demonstrate conformity of the part are in the public domain, and published or established as part of
officially recognized standards
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EN 9107:2018 (E)
4 Direct delivery authorization requirements
4.1 General
The DDA process involves a DO and a PO. In a logical flow, a request for DDA is generated, an AA is
verified to have been established between the DO and PO, the DO validates airworthiness eligibility
(approved design), and the DO informs the PO of DDA approval or denial status (see Figure 2).
Figure 2 — Direct delivery authorization process flow
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EN 9107:2018 (E)
4.2 Design organisation
4.2.1 Procedures
A DO that intends to issue DDA to a PO shall develop internal procedures that, as a minimum, address:
a) the decision whether to grant or deny the PO DDA;
b) the determination of whether an AA (see Annex B) already exists with the PO, and if one does not
exist, the DO initiates the process to establish an AA that is agreed to by the PO;
c) the process used to determine an article is suitable for ultimate airworthiness certification by
ensuring the article is a constituent of a regulatory approved design (e.g., TC, STC, PMA, TSO, JTSO,
ETSO);
d) the process used and the type of documentation to transmit DDA approval or denial status to the
PO;
e) the process used to modify an existing DDA in whole or in part, and when required by the DO’s
regulatory authority to notify the DO’s regulatory authority of such modification;
f) transmission of DDA approval or denial status to the PO.
4.2.2 Direct delivery authorization
The DO shall provide DDA (see Annex C), for article(s) described in accordance with Annex D, to a PO
when:
a) a DO receives a DDA application.
b) the decision has been made by the DO to grant aftermarket rights to the PO for the article(s).
c) an AA in accordance with Annex B has been agreed to by the DO and the PO.
d) determination has been made that the article(s) is a constituent of a regulatory approved design
and is eligible for airworthiness certification.
4.2.3 Records
The DO shall issue and maintain records of DDAs, and make them available to regulatory authorities,
upon request.
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4.3 Production organisation
4.3.1 Procedures
A PO that intends to apply for DDA to a DO shall develop internal procedures that, as a minimum,
address:
a) the process to establish an AA is in existence between the DO and the PO;
b) the process to apply to the DO for DDA;
c) the process to receive the approved design and airworthiness data and plan appropriate
manufacturing, assembly, and inspection processes sufficient to establish and declare that the
produced article is complete, conforms to the approved design and airworthiness data, and is in
condition for safe operation;
d) the process to implement granted DDAs;
e) the process to act upon modified DDAs.
4.3.2 Direct delivery authorization
The PO shall make application for DDA to a DO in accordance with Annex C.
4.3.3 Records
The PO shall maintain records and make the following available, upon request:
a) AAs between the DO and PO (see Annex B);
b) DDAs granted by the DO (see Annex C);
c) Article listings reflecting granted DDA (see Annex D).
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EN 9107:2018 (E)
(informative)
Acronym log
AA Appropriate Arrangement
AMC Acceptable Means of Compliance
ARC Authorised/Authorized Release Certificate
CARs Canadian Aviation Regulations
CFR Code of Federal Regulations
DDA Direct Delivery Authorization
DO Design Organisation
EASA European Aviation Safety Agency
ETSO European Technical Standard Order
FAA Federal Aviation Administration
GM Guidance Material
IAQG International Aerospace Quality Group
JTSO Joint Technical Standard Order
NAA National Aviation Authority
PMA Parts Manufacturer Approval
PO Production Organisation
STC Supplemental Type Certificate
TC Type Certificate
TSO Technical Standard Order
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EN 9107:2018 (E)
(informative)
Appropriate arrangement
Annex B is comprised of:
— European Aviation Safety Agency (EASA) regulatory requirements in order to comply with
European Union (EU) Commission Regulation No. 748/2012, Annex I, Subpart G — Production
Organisation Approval, Part 21.A.133 and associated Acceptable Means of Compliance
(AMC)/Guidance Material (GM) requirements, when achieved via a contractual agreement; and
— two versions of an Appropriate Arrangement (AA) template, when the arrangement is not achieved
via a contractual agreement.
B.1 European aviation safety agency regulatory requirements
B.1.1 In compliance with EU Commission Regulation No. 748/2012, Annex I, Subpart G — Production
Organisation Approval, Part 21.A.133 requirements and associated AMC/GM requirements, the Design
Organisation and the Production Organisation must ensure, through an AA satisfactory coordination
between production and design.
B.1.2 When the design organisation and the production organisation are part of the same legal entity,
the AA or interfaces may be demonstrated by company procedures accepted by the National Aviation
Authority (NAA).
B.1.3 The AA is achieved by contractual agreement or a separate agreement, see attached template.
B.1.4 The AA must satisfy the intent and the spirit of the referenced regulations.
B.1.5 An arrangement is considered “appropriate”, if it is documented and satisfies the NAA that
coordination is satisfactory.
B.1.6 To achieve satisfactory coordination, the documented arrangements must at least define the
following aspects irrespective of whether the two organisations are separate legal entities or not:
a) the responsibilities of a design organisation, which assure correct and timely transfer of up-to-date
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