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Simplifying ISO/IEC 42001 AI Governance with Kosmoy — from policy on paper to controls at runtime

  • Writer: Umberto Malesci
    Umberto Malesci
  • Sep 24
  • 4 min read

Updated: 1 day ago

Understanding ISO/IEC 42001 in plain terms


ISO/IEC 42001 is the first international standard for an Artificial Intelligence Management System (AIMS). It tells organizations how to establish, implement, maintain, and continually improve the way they govern AI across its lifecycle. Any organization that develops or uses AI can adopt it; the standard follows the familiar ISO management‑system pattern (context, leadership, planning, support, operation, performance evaluation, improvement). 


Beyond the core clauses, Annex A provides a catalog of AI‑specific controls (often summarized as 38 controls across 9 objectives) covering policies, roles and responsibilities, lifecycle processes, transparency, supplier oversight, and more. In short: document your AIMS, run it day‑to‑day, monitor it, and keep improving it.

Two clauses matter a lot for real‑world AI: Clause 8 (Operation), which is about how you actually build, deploy and run AI systems responsibly, and Clause 9 (Performance evaluation), which expects ongoing monitoring, measurement, analysis and evaluation of AI performance and risk. This is where “runtime” shows up in practice; auditors will look for evidence that you aren’t just writing policies—you’re controlling and observing AI while it’s running.


The gap to close: ISO requires documented information and governance processes (the “paperwork”), andit expects operational control and monitoring (the “runtime”). If your AIMS is only a binder of policies, you’ll pass a desk review and still get burned in production. The right move is to do both. 



Why pursue ISO 42001 (and why runtime control matters)


Organizations adopt ISO 42001 to build trust, reduce AI risk, align with regulations, and make AI efforts measurable and improvable. It gives executives and stakeholders confidence that AI is being used responsibly, with auditable processes and clear accountability. The standard’s Plan‑Do‑Check‑Act rhythm isn’t there for show—you’re expected to adjust controls as models, data, threats, and regulations evolve. 

Practically, most teams start by getting the policies, roles, and risk registers in order. Good. But you also need runtime guardrails, access controls, logging, and dashboards so you can prove that your AI behaves when it actually runs—this is how you satisfy Clauses 8–9 and most of Annex A without living in spreadsheets. 



Kosmoy: turning ISO 42001 from paperwork into runtime control


Kosmoy is built governance‑first around an LLM Gateway—a control point that every AI call passes through—so policy isn’t just a PDF; it’s enforced in the hot path. You deploy Kosmoy on‑prem or in your private cloud, connect whichever models you approve (public or private), and manage usage centrally across business units. From there, Kosmoy gives you the runtime levers ISO 42001 expects you to have:


1) Policy becomes enforcement (Leadership, Policy; Annex A: policies/roles)

  • RBAC & model allow/deny lists at the gateway so only approved users and use cases can reach specific models.

  • Multiple gateways for different BUs/geos/use cases, each with its own policy profile.

  • An EU‑AI‑Act–aware guardrail (fine‑tuned SLM) to block disallowed requests/use patterns.


2) Operational risk is treated in real time (Planning, Risk; Annex A: lifecycle/usage)

  • Built‑in guardrails for PII, toxic content, and prompt‑injection; if triggered, the request/response is filtered or blocked—before the user ever sees it.

  • Cost/usage quotas per gateway (thresholds by tokens/$, daily/weekly/monthly windows) with warn/block actions—containing spend and preventing runaway usage.


3) Documented information—with runtime evidence (Support; Annex A: transparency)

  • Conversation logging and an Insights Dashboard for usage, costs, model mix, guardrail hits, and user feedback—your audit trail and management‑review packet, generated continuously.


4) Controlled, repeatable AI development (Operation; Annex A: lifecycle)

  • Studio & RAG‑in‑a‑Box: no‑code ingestion pipelines (chunking, metadata, embeddings), configurable retrievers(lexical/semantic/hybrid + re‑ranking), prompt versioning, and QA/QC before roll‑out—so teams follow the same, auditable path to production


5) Resilience and cost‑quality balance (Operation/Performance; Annex A: suppliers)

  • LLM Routers (algorithmic and agentic) for fault tolerance, load balancing, and cost optimization—including failover if a provider degrades.

  • On‑prem / private‑cloud deployment and multi‑LLM orchestration reduce vendor lock‑in and support data‑sovereignty constraints.


Net effect: policy-as-code + controls-at-runtime. You still produce the policies and records ISO 42001 asks for, but you also prove compliance continuously with live enforcement and monitoring mapped to Clauses 8–9. 



What “good” looks like under ISO 42001—with Kosmoy

During build (Clause 8): teams assemble RAG agents through Studio, not ad‑hoc scripts. Prompts are versioned, retrievers are standardized, and pre‑production QA/QC is mandatory. Runtime guardrails are defined up front as part of the release checklist. 


In production (Clauses 8–9): every request flows through the Gateway → Guardrails → Router → Models. RBACand quotas apply. If a prompt‑injection attempt occurs, the guardrail blocks and logs it. Insights shows usage, costs, feedback, and safety events across apps. Management reviews use those dashboards and logs as evidence for audits and improvements. 


Over time (Clause 10): your AIMS follows PDCA: guardrail hits, user feedback, quality/cost signals, and incidents drive adjustments to prompts, models, routing rules, or policies. That’s continual improvement with data, not intent.



A pragmatic ISO 42001 implementation plan (fast track)

  1. Scope & inventory AI use cases and data flows; tie each to an intended purpose and risk level (Clause 4). 

  2. Stand up the Gateway and RBAC; define per‑use‑case model allowlists/denylists.

  3. Policy as guardrails: enable PII/toxicity/prompt‑injection guardrails; turn on the AI‑Act guardrail where relevant; set quotas.

  4. Standardize build with Studio/RAG‑in‑a‑Box and enforce QA/QC before go‑live (Clause 8).

  5. Observability on day one: logging + dashboards + alerting; define retention and reviewer roles (Clause 9).

  6. Supplier strategy: use multi‑LLM and on‑prem/private‑cloud where needed for resilience/sovereignty (Annex A supplier controls). 

  7. Management review & internal audit: use live metrics and logs as evidence; record corrective actions (Clauses 9–10).

  8. Statement of Applicability: map Annex A to what Kosmoy enforces at runtime + your supporting procedures; prep for Stage 1.



Visual aids & resources to include with the post

  • AIMS “Paperwork ↔ Runtime” map: left column lists ISO 42001 artifacts (policy, roles, risk register, training, audit plan). Right column shows Kosmoy runtime controls (RBAC, guardrails, quotas, logging, routers). Tie each Annex A objective to both a document and a control. 

  • ISO 42001 × Kosmoy matrix (downloadable PDF): rows = Clauses 4–10 + Annex A objectives; columns = “Evidence (docs/logs)” and “Runtime control”; cells point to specific Kosmoy features.

  • Runtime architecture diagram: channels/apps → Kosmoy Gateway (RBAC, guardrails, quotas, logging, routers) → approved models (cloud + on‑prem) → Insights.



The takeaway

ISO/IEC 42001 isn’t a paperwork exercise. It’s a management system that demands live control and continuous monitoring of AI. Kosmoy gives you the runtime control plane—guardrails, routing, access control, quotas, logging, and observability—and it generates the evidence that auditors want. Put simply: you certify with documents, and you stay compliant with runtime.


 
 
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