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BS EN 9115:2018

BS EN 9115:2018

$142.49

Quality Management Systems. Requirements for Aviation, Space and Defense Organizations. Deliverable Software (Supplement to EN 9100)

Published By Publication Date Number of Pages
BSI 2018 30
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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 ā€œproductā€ and ā€œsoftware productā€ are considered synonymous.

For the purposes of this document, the term ā€œservicesā€ may be considered a product.

PDF Catalog

PDF Pages PDF Title
2 undefined
6 Rationale
Foreword
Intended Application
7 0 Introduction
0.1 General
0.2 Quality management principles
0.3 Process approach
0.3.1 General
0.3.2 Plan-do-check-act cycle
0.3.3 Risk-based thinking
0.4 Relationship with other management system standards
8 1 Scope
2 Normative references
3 Terms and definitions
13 4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
14 5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities, and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
15 7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.5.1 General
7.1.5.2 Measurement traceability
16 7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
17 8.1.1 Operational risk management
18 8.1.1.1 Product integrity
8.1.2 Configuration management
19 8.1.3 Product safety
8.1.4 Prevention of counterfeit parts
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
20 8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
21 8.3.4 Design and development controls
8.3.5 Design and development outputs
22 8.3.6 Design and development changes
8.4 Control of externally provided processes, products, and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
23 8.5.1 Control of production and service provision
24 8.5.1.1 Control of equipment, tools, and software programs
8.5.1.2 Validation and control of special processes
8.5.1.3 Production process verification
8.5.2 Identification and traceability
25 8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
26 8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
27 9 Performance evaluation
9.1 Monitoring, measurement, analysis, and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
28 9.3.2 Management review inputs
9.3.3 Management review outputs
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

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BS EN 9115:2018
$142.49