ISO 42001 · AI management

ISO 42001 AI management for health and care

We help organisations building or deploying AI put in place an ISO 42001 AI management system, joined up with clinical safety and AI assurance.

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What is ISO 42001?

ISO 42001 is the international standard for AI management systems. It sets out how an organisation governs the development and use of AI responsibly.

In health and care, AI also needs clinical safety assurance under DCB0129 and DCB0160. We bring ISO 42001, clinical risk management and AI assurance together in one approach.

What we deliver

  • Gap analysis against ISO 42001 with a clear plan
  • AI policy, roles and governance structure
  • AI risk and impact assessment
  • Lifecycle controls for data, models and monitoring
  • Alignment with DCB0129, DCB0160 and AI assurance
  • Internal audit and certification readiness

Frequently asked questions

Who is ISO 42001 for?

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Any organisation that develops, provides or uses AI systems and wants a recognised way to govern them.

Does ISO 42001 replace clinical safety?

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No. In health and care, AI still needs clinical risk management under DCB0129 and DCB0160. ISO 42001 sits alongside it.

Can we combine it with ISO 27001?

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Yes. ISO 42001 follows the same management system structure, so it fits well with an existing ISMS.

Talk to an Expert

Book a free call with a DigiSafe expert. We'll scope the work, timelines and the right partnership, plain English, no jargon.

Direct clinical access

Meet the team, Clinical Safety Officers, DPOs & Medical Device Experts.

Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.

Portrait of Rebecca Wilson, Founder, CEO & Director of Clinical Safety

Rebecca Wilson

Founder, CEO & Director of Clinical Safety

Portrait of Stacey Dudley, Chief Operating Officer

Stacey Dudley

Chief Operating Officer

Portrait of Suzanne Ash, Medical Device and Compliance Expert

Suzanne Ash

Medical Device and Compliance Expert

Portrait of Tom Falcon, Medical Device and Compliance Expert

Tom Falcon

Medical Device and Compliance Expert

Portrait of Steve Robson, Clinical Safety Officer, Nurse

Steve Robson

Clinical Safety Officer, Nurse

Portrait of Dr Lizzie Marston, Clinical Safety Officer, GP

Dr Lizzie Marston

Clinical Safety Officer, GP

Portrait of Mona Kapinga, Clinical Safety Officer, Pharmacist

Mona Kapinga

Clinical Safety Officer, Pharmacist

Portrait of Matthew Olsson, Clinical Safety Officer, Lead Trainer, Paramedic

Matthew Olsson

Clinical Safety Officer, Lead Trainer, Paramedic

Portrait of Zara Mahmood, Clinical Safety Officer, Occupational Therapist

Zara Mahmood

Clinical Safety Officer, Occupational Therapist

Portrait of Shell Mcvey, Business Support Manager

Shell Mcvey

Business Support Manager

Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.