This document specifies the requirements for the effective control of non-deliverable software. This document can be used during the design, development, test, production, release, use, maintenance, and retirement of non-deliverable software. This can include non-deliverable software procured from external suppliers and utilized in the design, production, evaluation, test, acceptance, or calibration of a deliverable product.
This document focuses solely on the unique requirements of the operational processes that pertain to non-deliverable software as identified below:
This document applies to non-deliverable software (including firmware) that affects a deliverable product or service. Following are several applications and supporting examples of non-deliverable software that is within the scope of this document:
— design and development: modelling, simulation, virtual reality, virtual machine, computer-aided design (CAD), three-dimensional (3D) modelling and analysis tools, software compiler, and code generators;
— manufacturing: additive manufacturing, computer numerical controlled (CNC) programs, robotics, factory automation, tools that load deliverable software, software used in special process (e.g. heat treat, shot peen, sonic wall inspection), and automated manufacturing software (i.e. pick and place);
— verification, validation and maintenance: 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, emulator, and software used in post-delivery service provisions.
The following types of software are not within scope of this document:
— deliverable software (refer to EN 9115);
— manufacturing and measuring equipment embedded software (e.g. operating system, drivers);
— enterprise or office software (e.g. MS Office, word processing or spreadsheet applications, Teams, network software, email, employee management system).
Operational processes not covered in this document are addressed by the respective organization’s quality management system (QMS), based on the EN 9100-series (i.e. EN 9100, EN 9110, EN 9120) and/or ISO 9001 standards.