All Processes

Shared library: Process Registry, Annex A catalog, traceability spine, completeness scoring, menu ordering, Merkle helpers, navigation patches.

Central evidence engine. 5 PDCA phases, 39 diagram boxes, governance gates, context/stakeholder registers, automatic evidence aggregation from all processes.

Structured 3-tab understanding records for 4.1 (context), 4.2 (interested parties), 4.3 (scope). Verbatim clause guidance + evidence fields.

AI risk assessment, Statement of Applicability (SoA), risk treatment, impact assessment (6.1.4), and Annex A control mapping.

Controlled change management with full audit trail, QMS logs, and integration to the AIMS hub change box.

Supplier lifecycle, GPAI/LLM vendor due diligence, acceptance evaluation, ongoing monitoring and evidence packages.

Operational planning, risk assessment/treatment during operation, impact assessment, and runtime controls.

AI system lifecycle processes per ISO/IEC 5338/5339. Design, development, validation and deployment phases.

Documented information register, competence & training tracking, version control integration.

Data quality, lineage, management processes aligned with ISO/IEC 5259 and 8183 series.

Performance monitoring, measurement, incidents, personal data breaches, post-market surveillance.

Internal audit programme, four-stage workflow, findings, and automatic CAPA creation.

Management review inputs/outputs with twelve-sub-process workflow and decision recording.

Continual improvement register + full CAPA (nonconformity & corrective action) lifecycle.