Documentation & QMS Support

The AI management system and regulatory documentation that turn "we govern our AI" into something you can prove on demand, built to ISO/IEC 42001 and mapped to the framework your regulator already enforces.

A tabbed regulatory binder open on a desk

The problem

Your AI works. What you cannot yet show is that it is governed. When an auditor arrives, the question is never “is the model good,” it is “show me your controls, your records, and the evidence they were followed.”

Most organizations deploying AI in regulated environments have the capability and none of the paper: no AI management system of record, no documented risk controls, no traceable link between the AI they run and the standard they are held to. That gap is where findings come from. A management system you cannot produce on demand is the same as not having one.

What we do

We stand up the AI management system (AIMS) and the documentation record that make your AI defensible to an auditor: the governing standard built to certifiable form, the artifacts that evidence it, and a clear map from that system to the sector rule that binds you. You get an audit-ready quality management system, not a binder of policies no one can trace to practice.

We run our own governed systems on this same documentation discipline. The controls we write for you are the controls we already keep for ourselves.

How we do it

  • Assess. We baseline your current state against ISO/IEC 42001 and your binding sector framework, and name the gaps precisely: what exists, what is missing, what is claimed but not evidenced.
  • Build. We author the AIMS: scope, AI policy, roles, risk and impact assessment procedures, admissibility controls, records, and the operating procedures that connect them. Where you already run ISO 9001 or ISO/IEC 27001, we integrate rather than duplicate.
  • Map. We trace each control to the framework that governs your sector, so one management system answers to DO-178C, NERC CIP, 21 CFR Part 11, or GxP without a parallel paperwork stack.
  • Prepare. We ready you for the audit or certification review: evidence packages, internal audit, and a mock review against the questions an assessor will actually ask.

What you get

  • An AI management system documentation set, structured to ISO/IEC 42001.
  • AI policy, scope statement, and defined roles and responsibilities.
  • AI risk and impact assessment procedures, with completed records.
  • Admissibility controls: documented limits on what each system may accept and do.
  • Integration with existing ISO 9001 and ISO/IEC 27001 management systems, where present.
  • A framework mapping matrix tracing AIMS controls to DO-178C, NERC CIP, 21 CFR Part 11, or GxP.
  • 21 CFR Part 11 controls documentation (audit trails, electronic records and signatures) where in scope.
  • An internal audit and gap assessment report, and an audit and certification readiness package including a mock review.

Frameworks

We build to ISO/IEC 42001 (AI management system), integrate ISO 9001 and ISO/IEC 27001 where you already operate them, and map across DO-178C for aerospace and defense, NERC CIP for energy and utilities, and 21 CFR Part 11 and GxP for life sciences.

Who it’s for

Quality and regulatory leads in regulated-stakes environments: the people who own the audit outcome and need an AI management system their assessors will accept. Engaged by project, for a defined build, or on retainer for ongoing documentation and audit readiness.

Bring us your framework and your gap. Request a briefing.