EN 9115-2018 Quality Management Systems - Requirements for Aviation Space and Defense Organizations - Deliverable Software (Supplement to EN 9100).pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Quality Management Systems - Requirements for Aviation, Space and Defense Organizations - Deliverable Software (Supplement to EN 9100)BS EN 9115:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9115 July 2018 IC

2、S 03.100.70; 03.120.10; 35.080; 49.020 Supersedes EN 9115:2013English Version Quality Management Systems - Requirements for Aviation, Space and Defense Organizations - Deliverable Software (Supplement to EN 9100) Systmes de management de la Qualit - Exigences pour les Organisations de lAronautique,

3、lEspace et la Dfense - Logiciel livrable (Supplment lEN 9100) Qualittsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt, Raumfahrt und Verteidigung - Mitgelieferte Software (Ergnzung zu EN 9100) This European Standard was approved by CEN on 28 March 2018. CEN members are bound to com

4、ply 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-CENELE

5、C 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 s

6、ame 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, Luxembour

7、g, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-104

8、0 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9115:2018 ENational forewordThis British Standard is the UK implementation of EN 9115:2018. It supersedes BS EN 9115:2013, which is withdrawn.The UK participation in i

9、ts preparation was entrusted to Technical Committee ACE/1, International and European Aerospace Policy and Processes.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contra

10、ct. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 74967 4ICS 03.120.10; 35.080; 49.020; 03.100.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard w

11、as published under the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 9115:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 9115 July 2018 ICS 03.100.70; 03.120.10; 35.080; 49.020

12、Supersedes EN 9115:2013English Version Quality Management Systems - Requirements for Aviation, Space and Defense Organizations - Deliverable Software (Supplement to EN 9100) Systmes de management de la Qualit - Exigences pour les Organisations de lAronautique, lEspace et la Dfense - Logiciel livrabl

13、e (Supplment lEN 9100) Qualittsmanagementsysteme - Anforderungen an Organisationen der Luftfahrt, Raumfahrt und Verteidigung - Mitgelieferte Software (Ergnzung 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 Regul

14、ations 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 membe

15、r. 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. CE

16、N 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,

17、Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of explo

18、itation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 9115:2018 EBS EN 9115:2018EN 9115:2018 (E) 2 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

19、 . 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 BS EN 9115:2018EN 9115:2018 (E) 3 European foreword This document (EN 9115:2018) has been prepared by the Aerospace and Defence Industri

20、es 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 C

21、EN. 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 so

22、me 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 co

23、untries 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,

24、Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 9115:2018EN 9115:2018 (E) 4 Rationale This European standard supersedes the initial release of prEN 9115 published in April 2010. This European standard has been revised to incorpo

25、rate 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

26、 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 so

27、ftware 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

28、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 avi

29、ation, 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 el

30、imination 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 supplementa

31、l 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 organizations EN 9100-r

32、egistration 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

33、methodology (e.g., objected oriented design, unified modelling language). BS EN 9115:2018EN 9115:2018 (E) 5 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 requ

34、ired 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 s

35、oftware. 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. BS EN 9115:2018EN 9115:2018 (E) 6 1 Scope The requirements

36、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 f

37、or 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 delivera

38、ble 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), Programmab

39、le 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 (C

40、OTS) 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

41、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 Eur

42、opean 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

43、 “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

44、 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-1

45、2 BS EN 9115:2018EN 9115:2018 (E) 7 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

46、 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 configuratio

47、n management purposes SOURCE: RTCA/DO-178 or EUROCAE ED-12, modified 3.4 critical items definition in EN 9100, 3.2, applies with the following clarification for software Critical items in software are those characteristics, requirements, or attributes that have been determined to be most important t

48、o achieve product realization (e.g., safety, maintainability, testability, usability, performance). For example, in the case of an aircrafts flight control system software, the response time could be elevated to a critical item to ensure overall performance characteristics are met; or if a project h

49、as customer specific testability requirements, cyclomatic complexity may become a critical item. 3.5 Cyclic Redundancy Check CRC type of function that takes a data stream of any length as an input and produces a value of a certain space (commonly a 32-bit integer) as an output. A CRC can be used to detect alteration of data during transmission or storage 3.6 digital signature digital signature scheme type of asymmetric cryptography used to express compliance with the security properties of a handwritten signature on paper 3.7 Information A