compliance-os

EU AI Act (Regulation (EU) 2024/1689) Article-cited compliance operator. Three decisions: AI system risk tier (Article 5 / 6+ Annex III / 50 / minimal), conformity assessment routing (Article 43 Module A vs H + Annex IV docs), per-role obligation matrix (provider/deployer/importer/distributor + GPAI). NOT executive AI strategy (see cs-caio-advisor). NOT a legal substitute (engage counsel for novel cases).

ISO/IEC 42001:2023 AI Management System (AIMS) implementation + internal audit operator. Three decisions: AIMS gaps against Clauses 4-10, AI risk register per Annex A + ISO 23894, Clause 9.2 internal audit plan. NOT executive AI strategy (see cs-caio-advisor). NOT EU AI Act conformity (see cs-ai-act-compliance).

ISO/IEC 27001:2022 ISMS audit + implementation persona. Sample-driven; samples real records, not curated demos. Coordinates with SOC 2 (75% overlap), ISO 42001 (60% reuse for AIMS data + supplier controls), and GDPR Article 32 organizational measures. NOT executive cybersecurity strategy (see cs-ciso-advisor for that).

Multi-framework compliance officer orchestrating cross-framework programs. Routes per-framework deep work to specialist skills (ISO 42001, EU AI Act, ISO 27001, SOC 2, GDPR, ISO 13485, etc.). Owns framework selection, cross-framework overlap, audit calendar, unified evidence pool. NOT a per-framework deep-dive (those live in ra-qm-team specialist skills).

ISO 13485:2016 QMS audit persona — Design Control + CAPA + Process Validation focused. Coordinates with ISO 14971 (risk file), MDR 745 (technical documentation), FDA QSR (substantially harmonized post-Feb 2026). NOT executive product strategy (see cs-cpo-advisor for that).

/cs:ai-act-readiness <system> — EU AI Act 6-question forcing interrogation. Use during AI-system intake, before EU deployment, or during annual compliance refresh as Article 113 obligations phase in (2025-02-02 / 2025-08-02 / 2026-08-02 / 2027-08-02).

/cs:aims-audit <scope> — ISO/IEC 42001 AIMS internal-audit 6-question forcing interrogation. Use before certification stage 1, before annual internal audit cycles, or when onboarding a new AI system into an existing AIMS.

Compliance OS — meta-orchestrator that lets compliance teams CONFIGURE which frameworks apply, COMPUTE cross-framework control overlap, SIMULATE internal audits, and CONSOLIDATE evidence across multiple frameworks. Four decisions: (1) Given a company profile, which of the 12 supported frameworks apply (ISO 27001/13485/42001/14971, EU AI Act, MDR 745, GDPR, SOC 2, FDA QSR, NIST CSF 2.0, NIS2, HIPAA)? (2) Across selected frameworks, which controls overlap and how much evidence reuses? (3) For a given framework + scope, what does a realistic mock audit produce — drawing from the 205-scenario library? (4) Across selected frameworks, what's the unified evidence checklist with reuse map? Use when standing up a multi-framework program, planning the annual audit calendar, or preparing for certification stage 1. Does NOT replace per-framework skills (it orchestrates them).

/cs:compliance-readiness <program> — Multi-framework compliance officer 6-question forcing interrogation of any compliance program. Use before starting a new framework, planning the annual audit calendar, or preparing for certification stage 1.

/cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.