EN 9115:2013
(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 document 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
for the aviation, space, and defense industry. This includes, as required, support software that is used in the
development and maintenance of deliverable software. The deliverable software may be stand-alone,
embedded, or loadable into a target computer.
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 shall agree on the extent of applicability of this supplement.
NOTE 1 For airborne electronic hardware guidance, see RTCA/DO-254 or EUROCAE ED-80; and for product
realization requirements, see EN 9100.
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.
NOTE 2 This document is independent of the life cycle models (e.g., waterfall, spiral, evolutionary,
Qualitätsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt, Raumfahrt und Verteidigung - Mitgelieferte Software (Ergänzung zu EN 9100)
1.1 Allgemeines
Es gelten die Anforderungen von EN 9100 zuzüglich der folgenden Präzisierung für Software.
Dieses Dokument ergänzt die Normanforderungen von EN 9100 bezüglich der mitgelieferten Software und enthält Anforderungen des Qualitätsmanagementsystems an Organisationen, die mitgelieferte Software für die Luft-, Raumfahrt- und Verteidigungsindustrie entwerfen, entwickeln und/oder herstellen. Bei Bedarf um-fasst das auch Unterstützungssoftware, die bei der Entwicklung und Instandhaltung mitgelieferter Software eingesetzt wird. Die mitgelieferte Software darf eigenständig, eingebettet in oder in den Zielcomputer ladbar sein.
Wenn eine Hardware-Beschreibungssprache (HDL [en: Hardware Description Language]) oder eine Sprache höherer Ordnung als Quelle für das Design elektronischer Hardware genutzt wird (z. B. Anwendungsspezi-fische Integrierte Schaltung [ASIC], Programmierbare Logische Schaltung [PLD]), müssen Organisation und Kunde den Umfang, in dem diese Ergänzung angewendet wird, vereinbaren.
ANMERKUNG 1 Zu Richtlinien für elektronische Hardware in Luftfahrzeugen siehe RTCA/DO-254 oder EUROCAE ED-80, zu Anforde¬rungen bei der Produktrealisierung siehe EN 9100.
Wenn handelsübliche (COTS) Software oder Fertig-Software in das zu liefernde Produkt integriert wird, müs-sen Organisation und Kunde den Umfang, in dem diese Ergänzung angewendet wird, vereinbaren.
Für den Zweck dieses Dokumentes werden die Begriffe „Produkt" und „Software-Produkt" als gleichbedeu-tend angesehen.
ANMERKUNG 2 Dieses Dokument ist unabhängig von Lebenszyklus-Modellen (z. B. Wasserfall-, Spiral-, evolutionä¬res, inkrementelles Modell) oder Methodiken (z. B. objektorientierter Entwurf, Vereinheitlichte Modellierungssprache, rechnergestützt).
1.2 Anwendung
Es gelten die Anforderungen von EN 9100 zuzüglich der folgenden Präzisierung für Software.
Ausnahmen von den Anforderungen in Abschnitt 7 sollten ausschließlich nach Analyse der Software-Eigen-schaften erwogen werden (z. B. Größe, Sicherheit, Schutz, Komplexität, Kritikalität, Risiko).
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 dokument dopolnjuje standardne zahteve EN 9100 za dobavljivo programsko opremo in vsebuje zahteve sistema vodenja kakovosti za organizacije, ki oblikujejo, razvijajo in/ali proizvajajo dobavljivo programsko opremo za letalsko, vesoljsko in obrambno industrijo. To po potrebi vključuje podporno programsko opremo, ki se uporablja pri razvijanju in vzdrževanju dobavljive programske opreme. Dobavljiva programska oprema je lahko samostoječa, vdelana ali jo je možno naložiti v ciljni računalnik. 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 strinjati o obsegu uporabnosti tega dodatka. 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. Zahteve EN 9100 se uporabljajo z naslednjimi pojasnitvami za programsko opremo. Izključitve pri zahtevah v točki 7 naj bi se upoštevale šele po analizi lastnosti programske opreme (npr. velikost, varnost, zaščita, kompleksnost, kritičnost, tveganje).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2013
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Quality Management Systems - Requirements for Aviation, Space and Defence
Organizations - Deliverable Software (Supplement to EN 9100)
Qualitätsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt,
Raumfahrt und Verteidigung - Lieferbare 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 9115:2013
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
95.020 Vojaška tehnika. Vojaške Military engineering. Military
zadeve. Orožje affairs. Weapons
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 9115
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2013
ICS 03.120.10; 49.020
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 pour Qualitätsmanagementsysteme - Anforderungen an
les Organisations de l'Aéronautique, l'Espace et la Défense Organisationen der Luftfahrt, Raumfahrt und Verteidigung -
- Logiciel livrable (Supplément à l'EN 9100) Mitgelieferte Software (Ergänzung zu EN 9100)
This European Standard was approved by CEN on 18 June 2011.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9115:2013: E
worldwide for CEN national Members.
Contents Page
Foreword .4
0 Introduction .6
0.1 General .6
0.2 Process approach .6
QUALITY MANAGEMENT SYSTEMS — REQUIREMENTS .6
1 Scope .6
1.1 General .6
1.2 Application .6
2 Normative references .7
3 Terms and definitions .7
4 Quality management system . 10
4.1 General requirements . 10
4.2 Documentation requirements . 10
4.2.1 General . 10
4.2.2 Quality manual . 10
4.2.3 Control of documents . 11
4.2.4 Control of records. 11
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 . 11
5.5.1 Responsibility and authority . 11
5.5.2 Management representative . 11
5.5.3 Internal communication . 11
5.6 Management review . 12
5.6.1 General . 12
5.6.2 Review input . 12
5.6.3 Review output . 12
6 Resource management . 12
6.1 Provision of resources . 12
6.2 Human resources. 12
6.2.1 General . 12
6.2.2 Competence, training and awareness . 12
6.3 Infrastructure . 12
6.4 Work environment . 13
7 Product realization. 13
7.1 Planning of product realization . 13
7.1.1 Project management . 13
7.1.2 Risk management . 14
7.1.3 Configuration management . 14
7.1.4 Control of work transfers . 16
7.2 Customer-related processes . 16
7.2.1 Determination of requirements related to the product . 16
7.2.2 Review of requirements related to the product . 16
7.2.3 Customer communication . 17
7.3 Design and development . 17
7.3.1 Design and development planning . 17
7.3.2 Design and development inputs . 17
7.3.3 Design and development outputs . 17
7.3.4 Design and development review . 17
7.3.5 Design and development verification . 18
7.3.6 Design and development validation . 18
7.3.6.1 Design and development verification and validation testing . 18
7.3.6.2 Design and development verification and validation documentation . 18
7.3.7 Control of design and development changes . 18
7.4 Purchasing . 19
7.4.1 Purchasing process . 19
7.4.2 Purchasing information . 19
7.4.3 Verification of purchased product . 19
7.5 Production and service provision . 19
7.5.1 Control of production and service provision . 19
7.5.1.1 Production process verification . 19
7.5.1.2 Control of production process changes . 20
7.5.1.3 Control of production equipment, tools and software programs . 20
7.5.1.4 Post-delivery support . 20
7.5.2 Validation of processes for production and service provision . 20
7.5.3 Identification and traceability . 20
7.5.4 Customer property . 20
7.5.5 Preservation of product . 20
7.6 Control of monitoring and measuring equipment . 21
8 Measurement, analysis and improvement . 21
8.1 General . 21
8.2 Monitoring and measurement .
...
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