DANSK DSF/PREN 9115-002 PDF

1.1 General This document defines the requirements for the effective control of non-deliverable software. This document can be used during the development, test, production, release, use, maintenance, and retirement of non-deliverable software. This can include non-deliverable software procured from outside manufacturers and incorporated in the production, evaluation, test, acceptance, or calibration of a deliverable product. When an organization outsources one or more of the processes involved in the creation of non-deliverable software, this document applies. This document focuses solely on the unique requirements of the operational processes that pertain to non-deliverable software as defined by section 1.2. Operational processes not covered in this document are addressed by the organization’s Quality Management System (QMS), based on EN 9100 and/or ISO 9001. 1.2 Application This document applies to non-deliverable software (including firmware) that directly affects the quality of a deliverable product or service. Following are several applications and supporting examples of non-deliverable software that is within scope of this document: - Design and Development: modelling, simulation, virtual reality, virtual machine, data science, Computer-Aided Design (CAD), Three-Dimensional (3D) modelling, analysis tools, software compiler, and code generators. - Manufacture: additive manufacturing data files, Computer Numerical Controlled (CNC) programs, robotics, factory automation, tools that load deliverable software, special process (e.g., heat treat, shot peen, sonic wall inspection), and automated manufacturing software (i.e., pick and place). - Verification and Validation: Coordinate Measuring Machine (CMM) programs, hardware or software qualification, code coverage, test scripts, analysis tools, acceptance test, production acceptance, calibration (inspection, test or calibration), simulator, and emulator. Non-deliverable software is not delivered to the customer under a contract or agreement. The following types of software are not within scope of this standard: - deliverable software (refer to EN 9115); - embedded manufacturing and test equipment software (e.g., operating system); - business systems or office software; and - information systems software for business applications.