EN 9115:2018
(Main)Quality Management Systems - Requirements for Aviation, Space and Defense Organizations - Deliverable Software (Supplement to EN 9100)
Quality Management Systems - Requirements for Aviation, Space and Defense Organizations - Deliverable Software (Supplement to EN 9100)
The requirements of EN 9100 apply with the following clarification for software.
This European standard supplements the EN 9100 standard requirements for deliverable software and
contains quality management system requirements for organizations that design, develop, and/or
produce deliverable software and services for the aviation, space, and defence industry. This includes,
as required, support software that is used in the development and maintenance of deliverable software
and services. The deliverable software may be stand-alone, embedded, mobile application, or loadable
into a target computer
This deliverable software may also be part of services (e.g., cloud environment, web hosted solutions or
platforms).
Where the use of Hardware Description Language (HDL) or high order language is utilized as the design
source of electronic hardware [e.g., Application Specific Integrated Circuit (ASIC), Programmable Logic
Device (PLD)]; the organization and customer, and/or supplier shall agree on the extent of applicability
of this supplement.
NOTE For airborne electronic hardware guidance, see RTCA/DO-254 or EUROCAE ED-80. For operations
requirements, see EN 9100, clause 8.
Where Commercial-Off-The-Shelf (COTS) or non-developmental software is integrated into a
deliverable product, the organization and customer shall agree on the extent of applicability of this
supplement.
For the purposes of this document, the terms “product” and “software product” are considered
synonymous.
For the purposes of this document, the term “services” may be considered a product.
Qualitätsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt, Raumfahrt und Verteidigung - Mitgelieferte Software (Ergänzung zu EN 9100)
Systèmes de management de la Qualité - Exigences pour les Organisations de l'Aéronautique, l'Espace et la Défense - Logiciel livrable (Supplément à l'EN 9100)
Sistemi vodenja kakovosti - Zahteve za organizacije za zračni promet, astronavtiko in obrambo - Dobavljivost programske opreme (dopolnilo k EN 9100)
Zahteve EN 9100 se uporabljajo z naslednjimi pojasnitvami za programsko opremo.
Ta evropski standard dopolnjuje zahteve standarda EN 9100 za dobavljivo programsko opremo in vsebuje zahteve sistema vodenja kakovosti za organizacije, ki oblikujejo, razvijajo in/ali proizvajajo dobavljivo programsko opremo in storitve za letalsko, vesoljsko in obrambno industrijo. To po potrebi vključuje podporno programsko opremo, ki se uporablja pri razvijanju in vzdrževanju dobavljive programske opreme in storitev. Dobavljiva programska oprema je lahko samostojna, vdelana, mobilna aplikacija ali pa jo je možno naložiti v ciljni računalnik. Ta dobavljiva programska oprema je lahko del storitev (npr., v oblaku, spletne rešitve ali platforme).
Kjer se uporaba opisnega jezika za strojno opremo (HDL) ali jezika visokega razreda uporablja kot vir oblikovanja elektronske strojne opreme (npr. integrirana vezja za določen namen (ASIC), logična naprava z možnostjo programiranja (PLD)), se morata organizacija in potrošnik in/ali dobavitelj strinjati o obsegu uporabnosti tega dodatka.
OPOMBA Za smernice glede elektronske opreme v zraku glejte RTCA/DO-254 ali EUROCAE ED-80. Za zahteve za obratovanje glejte standard EN 9100, točka 8.
Kjer je v dobavljivi izdelek vdelana kupljena komercialna (COTS) ali nerazvojna programska oprema, se morata organizacija in potrošnik strinjati o obsegu uporabnosti tega dodatka.
Za namene tega dokumenta sta izraza »izdelek« in »programski izdelek« enakovredna.
V tem dokumentu izraz »storitve« lahko pomeni izdelek.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2018
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SIST EN 9115:2013
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Quality Management Systems - Requirements for Aviation, Space and Defense
Organizations - Deliverable Software (Supplement to EN 9100)
Qualitätsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt,
Raumfahrt und Verteidigung - Mitgelieferte Software (Ergänzung zu EN 9100)
Systèmes de management de la Qualité - Exigences pour les Organisations de
l'Aéronautique, l'Espace et la Défense - Logiciel livrable (Supplément à l'EN 9100)
Ta slovenski standard je istoveten z: EN 9115:2018
ICS:
03.100.70 Sistemi vodenja Management systems
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 Vojaštvo na splošno Military in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 9115
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 35.080; 49.020 Supersedes EN 9115:2013
English Version
Quality Management Systems - Requirements for Aviation,
Space and Defense Organizations - Deliverable Software
(Supplement to EN 9100)
Systèmes de management de la Qualité - Exigences Qualitätsmanagementsysteme - Anforderungen an
pour les Organisations de l'Aéronautique, l'Espace et la Organisationen der Luftfahrt, Raumfahrt und
Défense - Logiciel livrable (Supplément à l'EN 9100) Verteidigung - Mitgelieferte Software (Ergänzung zu
EN 9100)
This European Standard was approved by CEN on 28 March 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 9115:2018 E
worldwide for CEN national Members.
Contents
Page
European foreword . 3
Rationale . 4
Foreword . 4
Intended Application . 4
0 Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Context of the organization . 11
5 Leadership . 12
6 Planning . 12
7 Support . 12
8 Operation . 14
9 Performance evaluation . 25
10 Improvement . 26
Bibliography . 27
European foreword
This document (EN 9115:2018) 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 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 January 2019, and conflicting national standards shall
be withdrawn at the latest by January 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.
This document supersedes EN 9115:2013.
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.
Rationale
This European standard supersedes the initial release of prEN 9115 published in April 2010. This
European standard has been revised to incorporate the new clause structure and content of
EN ISO 9001:2015. In addition, industry requirements, definitions, and notes have been revised in
response to EN ISO 9001:2015 and EN 9100:2016 revisions and stakeholder needs.
This is the second revision of EN 9115 which is an international supplement to EN 9100 providing
clarification of the corresponding EN 9100 requirements, as necessary, for deliverable software. In
some cases, where clarification is needed, it was necessary due to the complexity of software to
decompose “shall” statements in EN 9100 into more granular requirements. Where no software
clarification is required of the EN 9100 requirements, the following phrase is presented: “The
requirements of EN 9100 apply. No clarification required for software.”
NOTE This document must be used in conjunction with EN 9100:2016; references throughout the text to
EN 9100 are understood to mean EN 9100:2016.
Foreword
This document standardizes, to the greatest extent possible, the software quality management system
requirements for the aviation, space, and defence industry. This was accomplished through the
harmonization of quality management system requirements from international aviation, space, and
defence software standards and other applicable documents and good practice. The establishment of
common requirements for use at all levels of the supply-chain by organizations around the world
should result in improved quality, schedule, and cost performance by the reduction or elimination of
organization unique requirements and wider application of good practice.
Intended Application
The requirements of EN 9100 apply with the following clarification for software.
Organizations whose products are deliverable software or contain deliverable software should use the
supplemental EN 9115 standard when planning and evaluating the software design, development,
release, procurement, and management activities of the organization. The EN 9115 standard provides
guidance to the requirements of EN 9100 when it is desired to add “deliverable software” to the
organization’s EN 9100-registration certificate, and a greater depth of specificity and granularity to the
requirements for assuring that the objectives of EN 9100 will be met for deliverable software.
NOTE This document is independent of the life cycle models (e.g., waterfall, spiral, agile, evolutionary,
incremental) or methodology (e.g., objected oriented design, unified modelling language).
0 Introduction
0.1 General
The requirements of EN 9100 apply. No clarification required for software.
0.2 Quality management principles
The requirements of EN 9100 apply. No clarification required for software.
0.3 Process approach
The requirements of EN 9100 apply. No clarification required for software.
0.3.1 General
The requirements of EN 9100 apply. No clarification required for software.
0.3.2 Plan-do-check-act cycle
The requirements of EN 9100 apply. No clarification required for software.
0.3.3 Risk-based thinking
The requirements of EN 9100 apply. No clarification required for software.
0.4 Relationship with other management system standards
The requirements of EN 9100 apply. No clarification required for software.
1 Scope
The requirements of EN 9100 apply with the following clarification for software.
This European standard supplements the EN 9100 standard requirements for deliverable software and
contains quality management system requirements for organizations that design, develop, and/or
produce deliverable software and services for the aviation, space, and defence industry. This includes,
as required, support software that is used in the development and maintenance of deliverable software
and services. The deliverable software may be stand-alone, embedded, mobile application, or loadable
into a target computer
This deliverable software may also be part of services (e.g., cloud environment, web hosted solutions or
platforms).
Where the use of Hardware Description Language (HDL) or high order language is utilized as the design
source of electronic hardware [e.g., Application Specific Integrated Circuit (ASIC), Programmable Logic
Device (PLD)]; the organization and customer, and/or supplier shall agree on the extent of applicability
of this supplement.
NOTE For airborne electronic hardware guidance, see RTCA/DO-254 or EUROCAE ED-80. For operations
requirements, see EN 9100, clause 8.
Where Commercial-Off-The-Shelf (COTS) or non-developmental software is integrated into a
deliverable product, the organization and customer shall agree on the extent of applicability of this
supplement.
For the purposes of this document, the terms “product” and “software product” are considered
synonymous.
For the purposes of this document, the term “services” may be considered a product.
2 Normative references
The requirements of EN 9100 apply with the following clarification for software.
EN 9100:2016, Quality Management Systems — Requirements for Aviation, Space and Defence
Organizations
NOTE Documents referenced in this European standard, other than the normative references
(i.e., EN ISO 9000, EN ISO 9001, EN 9100), are listed in the supporting bibliographies (see Annex A and Annex B).
For undated references, the latest edition of the referenced document (including any amendments) applies. The
referenced documents are “informative” references; the requirements of these referenced documents do not add
any additional requirements to this European standard.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 9100 and EN ISO 9000 apply.
The following terms and definitions are included to support the understanding of this document.
3.1
baseline
approved, recorded configuration of one or more configuration items that thereafter serves as the basis
for further development, and is changed only through change control documented information
[see RTCA/DO-178 or EUROCAE ED-12]
3.2
Commercial-Off-The-Shelf (COTS) Software
commercially available applications sold by vendors through public catalogue listings. COTS software is
not intended to be customized or enhanced. Contract-negotiated software developed for a specific
application is not COTS software [see RTCA/DO-178 or EUROCAE ED-12]
Note 1 to entry: COTS software is a type of non-developmental software.
3.3
configuration item
one or more hardware/software entities treated as a unit for configuration management purposes or
software life cycle data treated as a unit for configuration management purposes
[SOURCE: RTCA/DO-178 or EUROCAE ED-12, modified]
3.4
critical items
definition
...
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