ASD-STAN PREN 9115-2017 Quality Management Systems - Requirements for Aviation Space and Defence Organizations - Deliverable Software (Supplement to EN 9100) (Edition P2).pdf

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1、 ASD STANDARD NORME ASD ASD NORM ASD-STAN prEN 9115:2017 Edition P2 2017-01 PUBLISHED BY THE AEROSPACE AND DEFENCE INDUSTRIES ASSOCIATION OF EUROPE - STANDARDIZATION Rue Montoyer, 10/5 - B-1000 Brussels, Belgium - Tel +32 2 775 81 26 - Fax +32 2 775 81 31 - www.asd-stan.org ICS: Descriptors: Note Te

2、chnically equivalent writings published in all IAQG sectors ENGLISH VERSION Quality Management Systems Requirements for Aviation, Space and Defence Organizations Deliverable Software (Supplement to EN 9100) Qualittsmanagementsysteme Anforderungen an Organisationen der Luftfahrt, Raumfahrt und Vertei

3、digung Mitgelieferte Software (Ergnzung zu EN 9100) Systmes de management de la Qualit Exigences pour les Organisations de lAronautique, lEspace et la Dfence Logiciel livrable (Supplment lEN 9100) This “Aerospace Series” Prestandard has been drawn up under the responsibility of ASD-STAN (The AeroSpa

4、ce and Defence Industries Association of Europe - Standardization). It is published for the needs of the European Aerospace Industry. It has been technically approved by the experts of the concerned Domain following member comments. Subsequent to the publication of this Prestandard, the technical co

5、ntent shall not be changed to an extent that interchange- ability is affected, physically or functionally, without re-identification of the standard. After examination and review by users and formal agreement of ASD-STAN, the ASD-STAN prEN will be submitted as a draft European Standard (prEN) to CEN

6、 (European Committee for Standardization) for formal vote and transformation to full European Standard (EN). The CEN national members have then to implement the EN at national level by giving the EN the status of a national standard and by withdrawing any national standards conflicting with the EN.

7、ASD-STAN Technical Committee approves that: “This document is published by ASD-STAN for the needs of the European Aerospace Industry. The use of this standard is entirely voluntary and its applicability and suitability for any particular use, including any patent infringement arising therefrom, is t

8、he sole responsibility of the user.” ASD-STAN reviews each standard and technical report at least every five years at which time it may be revised, reaffirmed, stabilized or cancelled. ASD-STAN invites you to send your written comments or any suggestions that may arise. All rights reserved. No parts

9、 of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior written permission of ASD-STAN. ISO 9001:2015 is reproduced in this document with the permission of the Intern

10、ational Organization for Standardization, ISO. No parts of this standard may be reproduced in any form without the prior written consent of ISO at copyrightiso.org. ISO Standards can be obtained from any ISO member and from the web site of the ISO Central Secretariat at www.iso.org. Copyright remain

11、s with ISO. Order details: E-mail: salesasd-stan.org Web address: http:/www.asd-stan.org/ Edition approved for publication Comments should be sent within six months after the date of publication to ASD-STAN Quality domain prEN 9115:2017 (E) 2 Contents Page Rationale . 4 Foreword 4 0 Introduction 5 0

12、.1 General 5 0.2 Quality management principles . 5 0.3 Process approach 5 0.3.1 General 5 0.3.2 Plan-do-check-act cycle. 5 0.3.3 Risk-based thinking . 5 0.4 Relationship with other management system standards . 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Context of the organiz

13、ation 10 4.1 Understanding the organization and its context 10 4.2 Understanding the needs and expectations of interested parties . 10 4.3 Determining the scope of the quality management system 11 4.4 Quality management system and its processes. 11 5 Leadership 11 5.1 Leadership and commitment . 11

14、5.1.1 General . 11 5.1.2 Customer focus 11 5.2 Policy 11 5.2.1 Establishing the quality policy 11 5.2.2 Communicating the quality policy . 11 5.3 Organizational roles, responsibilities, and authorities . 11 6 Planning . 11 6.1 Actions to address risks and opportunities 11 6.2 Quality objectives and

15、planning to achieve them . 12 6.3 Planning of changes . 12 7 Support 12 7.1 Resources 12 7.1.1 General . 12 7.1.2 People . 12 7.1.3 Infrastructure 12 7.1.4 Environment for the operation of processes . 12 7.1.5 Monitoring and measuring resources 13 7.1.6 Organizational knowledge 13 7.2 Competence 13

16、7.3 Awareness . 13 7.4 Communication . 13 7.5 Documented information 13 7.5.1 General . 13 7.5.2 Creating and updating 13 prEN 9115:2017 (E) 3 7.5.3 Control of documented information 13 8 Operation . 14 8.1 Operational planning and control 14 8.1.1 Operational risk management . 15 8.1.2 Configuratio

17、n management 15 8.1.3 Product safety 16 8.1.4 Prevention of counterfeit parts . 16 8.2 Requirements for products and services . 16 8.2.1 Customer communication . 16 8.2.2 Determining the requirements for products and services 16 8.2.3 Review of the requirements for products and services 16 8.2.4 Cha

18、nges to requirements for products and services . 17 8.3 Design and development of products and services 17 8.3.1 General . 17 8.3.2 Design and development planning . 17 8.3.3 Design and development inputs 17 8.3.4 Design and development controls 18 8.3.5 Design and development outputs . 18 8.3.6 Des

19、ign and development changes 18 8.4 Control of externally provided processes, products, and services . 19 8.4.1 General . 19 8.4.2 Type and extent of control 19 8.4.3 Information for external providers . 19 8.5 Production and service provision 19 8.5.1 Control of production and service provision 19 8

20、.5.2 Identification and traceability . 21 8.5.3 Property belonging to customers or external providers . 22 8.5.4 Preservation . 22 8.5.5 Post-delivery activities . 22 8.5.6 Control of changes 22 8.6 Release of products and services 23 8.7 Control of nonconforming outputs . 23 9 Performance evaluatio

21、n . 24 9.1 Monitoring, measurement, analysis, and evaluation 24 9.1.1 General . 24 9.1.2 Customer satisfaction 24 9.1.3 Analysis and evaluation . 24 9.2 Internal audit . 24 9.3 Management review 24 9.3.1 General . 24 9.3.2 Management review inputs. 24 9.3.3 Management review outputs 24 10 Improvemen

22、t 24 10.1 General . 24 10.2 Nonconformity and corrective action . 25 10.3 Continual improvement . 25 (informative) Bibliography. 26 Annex A(informative) Aviation, space and defence bibliography 27 Annex BFigure Figure 1 Relationship of information assurance, information security and cybersecurity 8

23、prEN 9115:2017 (E) 4 Rationale This standard supersedes the initial release of prEN 9115 published in April 2010. This 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 re

24、sponse to EN ISO 9001:2015 and EN 9100:2016 revisions and stakeholder needs. This is the second revision of prEN 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 clarif

25、ication 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 clarifi

26、cation 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 fo

27、r 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

28、 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. prEN 9115:2017 (E) 5 Intended Application The requirement

29、s of EN 9100 apply with the following clarification for software. Organizations whose products are deliverable software or contain deliverable software should use the supplemental prEN 9115 standard when planning and evaluating the software design, development, release, procurement, and management a

30、ctivities of the organization. The prEN 9115 standard provides guidance to the requirements of EN 9100 when it is desired to add “deliverable software” to the organizations EN 9100-registration certificate, and a greater depth of specificity and granularity to the requirements for assuring that the

31、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

32、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

33、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 sys

34、tem standards The requirements of EN 9100 apply. No clarification required for software. prEN 9115:2017 (E) 6 Quality management systems requirements 1 Scope The requirements of EN 9100 apply with the following clarification for software. This standard supplements the EN 9100 standard requirements f

35、or 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 mainten

36、ance 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 Desc

37、ription 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. N

38、OTE For airborne electronic hardware guidance, see RTCA/DO-254 or EUROCAE ED-80. For operations requirements, see EN 9100 section 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 o

39、f 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

40、 clarification for software. EN 9100:2016, Quality Management Systems Requirements for Aviation, Space and Defence Organizations NOTE Documents referenced in this standard, other than the normative references (i.e., EN ISO 9000, EN ISO 9001, EN 9100), are listed in the supporting bibliographies (see

41、 Annexes A and 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 standard. 3 Terms and defi

42、nitions 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. prEN 9115:2017 (E) 7 3.1 baseline approved, recorded configuration of one or more configuration

43、 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. C

44、OTS 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/softw

45、are entities treated as a unit for configuration management purposes or software life cycle data treated as a unit for configuration management purposes based on RTCA/DO-178 or EUROCAE ED-12 3.4 critical items the definition in EN 9100, clause 3.2, applies with the following clarification for softwa

46、re Critical items in software are those characteristics, requirements, or attributes that have been determined to be most important to achieve product realization (e.g., safety, maintainability, testability, usability, performance). For example, in the case of an aircrafts flight control system soft

47、ware, the response time could be elevated to a critical item to ensure overall performance characteristics are met; or if a project has customer specific testability requirements, cyclomatic complexity may become a critical item. 3.5 Cyclic Redundancy Check (CRC) type of function that takes a data s

48、tream 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 (also referred to as a digital signature scheme) type of asymmetric cryptography used

49、to express compliance with the security properties of a handwritten signature on paper 3.7 Information Assurance (IA) set of activities needed to protect information and information systems by ensuring availability, integrity, authentication, confidentiality, and non-repudiation including protection, detection, and reaction capabilities This includes activities conducted to reduce vulnerability of operational networks, Information Technology (IT), and computing equipment. Activities may include development of innovative and cost-effective ways to miti