Norms and standards in the introduction and use of requirements management tools

In highly regulated industries such as aviation, the automotive industry, rail transport and medical technology, norms and standards form the foundation 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 efficient, but also comply with industry-specific standards in order to ensure the conformity 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.

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Normative requirements for processes

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

• Aviation: 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: ISO 26262 requires clear structuring and traceability of safety requirements. Automotive SPICE also requires systematic documentation and tracking of requirements.
• Rail transportation: EN 50128 places particular emphasis on the traceability of safety-critical requirements.
• Medical technology: 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 recorded and tracked across all hierarchical levels, from collection to validation. This seamless management is a prerequisite for standard-compliant development processes in these industries.

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Normative requirements for the tool

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

• Aviation: A tool that is certified according to DO-254 for safety-critical hardware must be able to support and document safety analyses.
• Automotive: According to ISO 26262, it is essential that the tool integrates functional safety mechanisms in order to correctly implement safety-related requirements.
• Rail transportation: EN 50129 requires that safety-relevant data is consistently processed and stored in the tool.
• Medical technology: Standards such as ISO 13485 and FDA 21 CFR Part 820 require that the tool is safe and reliable and complies with regulatory requirements.

The technical requirements for requirements management tools therefore primarily concern reliability, scalability, security and compliance management. This is the only way to ensure that the tools can be used in safety-critical industries.

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Certification of the tool

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

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

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

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Norms and standards in ReqSuite® RM

As a comprehensive and flexible requirements management tool, ReqSuite® RM from OSSENO supports companies in regulated industries in complying with industry-specific norms and standards. The software is designed to not only fulfill the necessary requirements for processes and technical standards, but also to meet the certification requirements of different 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 compliance with standards.
2. Normative requirements for the tool: ReqSuite® RM fulfills the strict requirements of ISO 13485, IEC 61508 and EN 50128 through functions such as integrated encryption, audit trails and user rights management, making the tool usable in safety-critical industries and ensuring consistent and reliable processing of safety-relevant data.
3. Certification within the framework of company processes: ReqSuite® RM facilitates compliance with industry-specific certification requirements through automated reports and evidence required for audits. These functions support certification according to standards such as ISO 26262, FDA 21 CFR Part 820 and DO-254 and help to ensure compliance of the tool in the operational environment.

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Conclusion

In regulated industries such as aviation, the automotive industry, rail transportation and medical technology, norms and standards ensure the quality and safety of products. As a specialized requirements management tool, ReqSuite® RM from OSSENO fulfils these requirements and enables the standard-compliant implementation of product development processes. Through comprehensive traceability, effective change management and flexible adaptability, ReqSuite® RM ensures that companies in highly regulated markets can design their processes efficiently and compliantly.