Norms and Standards in the Introduction and Use of Requirements Management Tools

In heavily regulated industries such as aviation, automotive, rail transport and medical technology Norms and standards the basis for quality, safety and traceability. In addition to the products themselves, regulatory requirements are increasingly focusing on the underlying development processes and tools used. Requirements management tools Such as ReqSuite® RM from OSSENO must therefore not only be functionally powerful, but must also comply with industry-specific standards to ensure the compliance and efficiency of product development processes. This article highlights the most important norms and standards that influence the introduction and use of such tools, divided into three central areas: normative requirements for the processes, for the tool itself and for the certification of the tool.

Normative requirements for processes

In regulated industries, the processes, which are represented by a requirements management tool, are subject to strict requirements. These standards ensure that important requirements are traced and documented at every stage of development.

• aviation: The DO-178C requires full traceability between requirements, design decisions, and tests. A requirements management tool must therefore be able to seamlessly support all relevant processes.
• automotive industry: Die ISO 26262 requires a clear structuring and traceability of safety requirements. Also requires Automotive SPICE systematic documentation and monitoring of requirements
• Rail transport: Die EN 50128 attaches particular importance to the traceability of safety-critical requirements.
• medical technology: Die ISO 13485 and IEC 62304 require precise documentation and traceability of all changes in requirements and design.

A requirements management tool must ensure that requirements can be captured and traced across all levels of the hierarchy, from collection to validation. This seamless administration is a prerequisite for standard-compliant development processes in these industries.

Normative requirements for the tool

Not only the processes shown, but also the tool itself are subject to specific requirements. It must meet technical and functional standards in order to be used in regulated industries.

• aviation: A tool that is based on DO-254 is certified for safety-critical hardware, must be able to support and document security analyses.
• automotive industry: After the ISO 26262 It is essential that the tool integrates functional safety mechanisms in order to correctly implement safety-relevant requirements.
• Rail transport: Die EN 50129 requires that safety-relevant data be processed and stored consistently in the tool.
• medical technology: Standards such as ISO 13485 and FDA 21 CFR Part 820 require that the tool is safe, reliable and complies with regulatory requirements.

The technical requirements for requirements management tools therefore relate primarily to Reliability, Scalability, Security and compliance management. This is the only way to ensure that the tools can be used in safety-critical industries.

Certification of the tool as part of business processes

Another key point concerns the certification of the tool within specific business processes. These certifications ensure that the tool meets legal and normative requirements in the respective environment.

• aviation: A requirements management tool must be able to perform audits according to DO-178C or DO-254 to pass by providing the required documentation on requirements, tests and verification.
• automotive industry: Companies that follow the ISO 26262 are certified, must prove that their tool correctly processes safety-critical requirements. Auch Automotive SPICE assesses how the tool supports development processes.
• Rail transport: A certification in accordance with EN 50128 and EN 50129 requires the tool to precisely record and track safety-critical requirements.
• medical technology: For certification in accordance with ISO 13485 or FDA 21 CFR Part 820 The tool must be able to fully support and document the quality assurance processes.

These certifications are proof of the tool's technical performance and compliance in operational use.

How ReqSuite® RM supports norms and standards

Supported as a comprehensive and flexible requirements management tool ReqSuite® RM by OSSENO companies in regulated industries while complying with industry-specific norms and standards. The software is designed in such a way that it not only meets the necessary requirements for processes and technical standards, but also meets the certification requirements of various industries.

1. Normative requirements for processes: ReqSuite® RM supports the traceability of requirements, design decisions and test cases in accordance with standards such as DO-178C, ISO 26262, and IEC 62304. By documenting versions and status changes in an audit-proof manner, ReqSuite® RM ensures that all requirements are recorded in accordance with the standards.
2. Normative requirements for the tool: With functions such as integrated encryption, audit trails and user rights management, ReqSuite® RM meets the strict requirements of ISO 13485, IEC 61508 and EN 50128. This makes the tool usable in safety-critical industries and ensures consistent and reliable processing of safety-relevant data.
3. Certification as part of business processes: ReqSuite® RM makes it easy to comply with industry-specific certification requirements through automated reports and evidence required for audits. These features support certification according to standards such as ISO 26262, FDA 21 CFR Part 820 and DO-254 and help ensure the tool's compliance in the operational environment.

Conclusion

Secure in regulated industries such as aviation, automotive, rail transport and medical technology Norms and standards the quality and safety of products. As a specialized requirements management tool, ReqSuite® RM from OSSENO meets these requirements and enables the implementation of product development processes in accordance with standards. Through comprehensive traceability, effective change management, and flexible adaptability, ReqSuite® RM ensures that companies in highly regulated markets can make their processes efficient and compliant.