Trustworthy AI, made practical: ISO/IEC 42001 + Opti Assist

Is your team experimenting with Generative AI and Large Language Models (LLMs) like Chat GPT? Maybe you’ve decided to just say no. Either way you’ve probably wondered: “How do we keep this powerful tech safe, fair, and compliant without slowing everyone down?” That’s exactly where ISO/IEC 42001 helps. It’s the new international standard for running an AI Management System (AIMS). Think of it as a playbook for using AI responsibly across your organisation. 

Unlike a long list of “don’ts,” ISO 42001 gives you a structured, repeatable way to plan, run, and improve AI use - covering leadership, risk, operations, and ongoing reviews. It also comes with a practical set of control themes (referred to here in Annex A) that point to the big things that matter in AI: accountability, data quality, transparency, privacy, safety, and more.  

What ISO/IEC 42001 actually covers (in plain English) 

• A management system for AI. Policies, responsibilities, and processes that help your business use AI safely and effectively—day in, day out.  

• Familiar structure. If you’ve met ISO 27001 or 9001, you’ll recognise the flow: context, leadership, planning, support, operations, performance checks, and improvement. 

• Annex A controls. Guidance across areas like roles and responsibilities, system lifecycle, data quality and provenance, transparency with stakeholders, and third-party relationships. It’s not a straitjacket—just a “don’t-miss” reference.  

• Plays nicely with other standards. ISO 42001 can sit alongside your existing info-security (ISO 27001) or privacy (ISO 27701) programs so you don’t duplicate effort. 

Why SMEs should care 

SMEs move fast. AI can help you move faster, but only if you keep trust and privacy front and centre. ISO 42001 is designed for real-world use, so teams can adopt AI with clear boundaries, transparent data handling, and built-in human oversight. It’s a practical way to show customers, partners, and auditors that you take responsible AI seriously. 

Where Opti Assist fits: policy to practice 

Opti Assist is ORCA’s secure, private GenAI workspace. We built it to make responsible AI feel natural for everyday users while quietly handling the complex bits in the background. 

Here’s how Opti Assist helps you align with ISO 42001 without slowing your day: 

• Policy-aware guardrails (you set the rules). Map your AI acceptable-use policy to Opti Assist once, then let role-based guardrails steer prompts, data types, and high-risk actions. Users get friendly nudges, not roadblocks. (Policies, internal organisation). 

• Smart data handling. Automatic detection and masking of sensitive info before any model call, plus configurable retention and export controls. (Data quality/provenance; third-party relationships). 

• Built-in human review. For higher-stakes tasks (e.g., HR letters, contracts), Opti Assist can require human sign-off and records the approval trail. (Lifecycle, use, accountability). 

• Transparent by design. Session banners and “About this answer” panels help users understand sources, limitations, and how their data is handled. (Information for interested parties). 

• Audit-ready logs. Every session records who, what, when, model/version, prompt template, context sources, and outcomes—exportable for internal audits and management reviews. (Performance evaluation & improvement). 

• Vendor due diligence support. Keep evidence that your chosen models/services meet your requirements (e.g., data usage terms, regional processing), all linked to each use case. (Third-party relationships). 

In short: you write simple policies; Opti Assist helps everyone follow them, consistently. 

A simple path to “we’re aligned with ISO 42001” 

You don’t need a giant program to get started. Here’s a friendly, low-lift rollout we’ve used with SMEs: 

1. Set the scope and write two short policies (1–2 pages each): 

2. Acceptable AI Use (who can use AI for what) 

3. Data Handling for AI (what’s allowed in prompts, retention rules)  Opti Asist will enforce these automatically via guardrails. (Policies, use, data). 

4. Capture risks in plain English for each LLM use case (e.g., “draft customer emails,” “summarise case notes”). Note the potential impacts (privacy, fairness, accuracy) and your mitigations (human review, masking, restricted sources). This aligns with ISO/IEC 23894 guidance on AI risk management.  

5. Turn on evidence. Use Opti Assist’s logs, model/version control, and approval trails to power your internal audits and management reviews each quarter.  

6. Keep improving. When you spot drift, incidents, or new needs, adjust your guardrails and policies. ISO 42001 expects a continuous-improvement mindset, not perfection on day one.  

What “good” looks like (and what your auditor will love) 

• Clear, short policies linked to specific Opti Assist settings. 

• A tidy register of AI use cases with simple risk notes and owners. 

• Evidence of training (prompt hygiene, PII awareness) and friendly in-app reminders. 

• Logs that show how high-risk content went through human review. 

• Regular management reviews with actions closed out. 

All of this maps neatly to ISO 42001’s structure and Annex A control themes and you won’t need to become a standards expert to run it.  

Why now? 

AI is becoming a core part of everyday work. ISO 42001 gives you a shared language and sensible guardrails; Opti Assist helps your team live those guardrails without friction. Together, they build trust with staff, customers, and regulators while keeping AI useful and safe.  

Sources (for the curious) 

• Schellman’s plain-English explainer of ISO/IEC 42001—structure, Annex A themes, and how it fits alongside other ISO systems. Schellman Compliance 

• NSF summary of the clause structure and Annex A emphasis areas (bias, transparency, accountability, data governance). NSF 

• ISO/IEC 23894 risk-management guidance for AI (pairs nicely with your 42001 rollout). ISO 

Get in touch with the ORCA Opti team and we would be happy to draft your “AIMS Starter Kit” inside your Opti Assist tenant: two policy templates, a one-page Risk & Impact canvas for each use case, and a friendly setup of guardrails, logs, and approval flows. Reach out to hello@orcaopti.ai