Does this sound familiar?

• Requirements from standards, laws, customer contracts, and compliance regulations are constantly increasing, yet no one can immediately say: What is currently valid, where does it apply, who is responsible, and what is the level of compliance?
• Requirements are maintained in parallel in various repositories and interpreted differently: This leads to gaps, duplication of effort, and contradictory implementations, especially when changes are made.
• Changes get lost in the shuffle of daily operations: New/revised requirements are not systematically distributed, reviewed, and tracked; decisions and justifications remain unclear.
• Traceability is subjective rather than verifiable: Audits cannot clearly demonstrate how a requirement is implemented in processes, SOPs/documents, risks/controls, and measures, and how this has evolved across different versions.
• Responsibilities and implementation occur without oversight: Status, deadlines, approvals, and escalations are opaque; tasks remain unfinished or are completed late.

This should be achieved through a robust process

• Central source and requirements structure: Standards, laws, regulations, contracts, and compliance guidelines must be managed as sources, and requirements must be derived from them in a structured manner.
• Clear control instead of a proliferation of variants: Requirements must be versioned, approved, and managed with a validity-based system, including a traceable history.
• • End-to-end traceability as a core principle: Requirements must be systematically linked to processes, documents/SOPs, risks/controls, as well as measures and workflows.
• Operational implementation as a workflow: Responsibilities, tasks, deadlines, reminders, escalations, and real-time status must be reliably mapped.
• Audit- and management-ready transparency: Filters, reports, and dashboards must show which requirements are open, critical, overdue, or unfulfilled.

Coverage in QS1

• Organizes requirements centrally and systematically via a source management system for standards, laws, regulations, contracts, and compliance documents; requirements are categorized, freely tagged, and tracked with responsibilities, status, and completion status.
• Manages requirements in an audit-proof manner through versioning and release processes: which requirement was valid when, what changes were made, and how decisions were justified.
• Ensures system-level traceability by bidirectionally linking requirements with processes, risks/controls, documents (including DMS/SOPs), as well as actions and workflows (plus continuous documentation).
• Translates complex sources into actionable to-dos: Centrally responsible parties can specify requirements internally and distribute them in a structured manner to process and risk owners.
• Controls implementation via integrated workflow and action management: tasks, deadlines, reminders, and escalations prevent delays; comments, queries, and decisions are traceable both at the requirement object and at process, risk, and document objects.
• Automatically informs affected parties of new or changed requirements and requests the review or adjustment of affected processes, risks, controls and documents using system support; evaluation is carried out via BI dashboards and reports.

Your result: Centralized transparency across all requirements, including responsibilities and fulfillment levels; reduced risk through clear management and versioning; true traceability for audits; faster implementation through workflows; and consistent implementation in processes, SOPs, and risk management. Parallel storage becomes a thing of the past.

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