ISO/IEC 42001:2023 defines how to build an Artificial Intelligence Management System (AIMS) that makes AI governance, risk management, and compliance demonstrable and measurable.
The standard sets requirements to establish, implement, maintain, and continually improve an AIMS using the PDCA cycle (Plan–Do–Check–Act), so that policies, roles, controls, and monitoring are documented across the entire AI system lifecycle. With ISO 42001 certification, you strengthen trust, reduce legal/operational risk, and demonstrate responsible use of AI.
What is ISO/IEC 42001:2023 and why it relates to Responsible AI
ISO/IEC 42001:2023 is the first international standard specifically for Artificial Intelligence Management Systems (AIMS). It defines requirements for establishing, implementing, maintaining, and continually improving an AIMS within an organization, structured around PDCA (Plan–Do–Check–Act).
This framework is not only about security or compliance. It provides a comprehensive approach to AI governance, ensuring AI systems are developed, deployed, and used with transparency, fairness, accountability, and respect for rights and societal impact.
ISO/IEC 42001 covers the entire AI lifecycle, from design and development through production operation and the monitoring of risks, bias, and failures. It applies to any type and size of organization: AI designers/developers, AI service providers, and organizations using AI in critical processes.
Who needs it & key benefits for export-oriented food SMEs
Export-oriented food SMEs increasingly use AI in critical operations such as visual quality inspection on production lines, real-time detection of foreign bodies or microbiological contamination, and end-to-end batch traceability. International customers and regulators now expect documented proof that these AI systems are reliable, repeatable, and controlled—because food safety, recall prevention, and brand reputation depend on them.
ISO/IEC 42001 certification demonstrates to customers, partners, and regulators that the company has implemented an AIMS with clear AI governance, risk assessment, supplier control for AI, and transparency in algorithmic decisions. It is an internationally recognized, certifiable standard (the first for AIMS); certification confirms the business manages AI responsibly across its lifecycle.
For an export-oriented SME, this acts as a “trust mark”: it reduces buyer objections, opens doors to demanding markets, and shows readiness for future regulatory inspections.
Core principles & the PDCA cycle in an AIMS
ISO/IEC 42001 requires the organization to run the AIMS as a living management system, not a static manual. It follows PDCA:
- Plan: set AI policies and objectives,
- Do: execute processes and controls in practice,
- Check: measure and evaluate AI performance and risk with KPIs,
- Act: implement corrective and improvement actions.
AI operations must be systematically monitored for accuracy, reliability, compliance, and ethical use, with results documented.
Leadership is critical. Top management must explicitly take responsibility for the AIMS by:
This makes compliance, transparency, and risk control measurable and demonstrable to customers and regulators.
Standard requirements & a quick view of Annex A controls
ISO/IEC 42001:2023 states what an AIMS must contain:
- a documented AI policy,
- defined roles and responsibilities,
- risk management processes,
- oversight mechanisms across the AI lifecycle.
It requires transparency, accountability, and fairness in AI operations:
It also includes requirements for data security and integrity, privacy protection, model reliability, and continuous performance monitoring so the organization can detect drift, errors, or unintended effects and prove compliance.
Annex A works like a spec sheet of controls. It groups AI governance areas into themed domains and translates them into auditable practices:
According to available descriptions, Annex A organizes nine thematic governance areas implemented through dozens of specific controls, covering everything from documentation to ongoing oversight.
AI governance & alignment with the EU AI Act
In ISO/IEC 42001, AI governance means clear accountability, not just a policy. The standard requires top management to approve policies for AI development and use—especially for high-risk applications—to assign roles and accountability and to document monitoring of each AI system throughout its lifecycle.
This includes:
Annex A extends this to external providers: it requires supplier control and oversight of third-party AI services to evaluate bias, transparency, model updates, and responsible use across the supply chain.
This directly connects to the EU AI Act. The regulation requires providers and users of high-risk AI to have a quality management system, formal risk management, technical documentation and logs, continuous monitoring, human oversight, and incident reporting to authorities.
Adopting ISO/IEC 42001 builds precisely these mechanisms (policies, records, third-party oversight), thus acting as proactive alignment with the new rules and signaling maturity and control to stakeholders ahead of regulatory audits.
AI risk management & the AI Impact Assessment (AIA)
ISO/IEC 42001 requires systematic, documented risk management for each AI system, including:
- identifying threats (threat modeling),
- assessing potential impact,
- defining mitigation controls across the AI lifecycle—from design to operation and monitoring.
Risks considered are not only technical (accuracy, drift, model robustness) but also legal, ethical, and societal: bias and discrimination, decision opacity, privacy violations, misuse, or unintended consequences. Annex A translates this risk logic into practical operational measures such as human oversight, decision traceability, data quality controls, stakeholder transparency, and AI supplier control.
A key element is the AI Impact Assessment (AIA): a documented assessment of how a given AI system may affect individuals, groups, customers, employees, or society (e.g., unjust application rejections, discriminatory outcomes, rights harms).
This is not done in a vacuum: it engages stakeholders and leads to corrective actions and monitoring KPIs within PDCA (e.g., accuracy thresholds, false-rejection rate, privacy incident metrics). This approach aligns with the EU AI Act, which requires documented risk management, continuous oversight, and accountability for high-risk AI.
AI lifecycle & continual improvement
ISO/IEC 42001 requires controls across the entire AI lifecycle: from data provenance and quality, through model design and training, to deployment, operations, and retirement. The standard calls for documented data quality/lineage, model verification and validation prior to release, and controls for bias, reliability, and regulatory compliance.
Post-deployment, the AIMS must continuously monitor real-world AI performance:
Following PDCA, performance is measured, safety/fairness/compliance are reassessed, and policies, controls, and technical settings are updated.
In short, ISO 42001 requires continuous monitoring and improvement of the AIMS based on actual production outcomes, so AI remains reliable and controlled.
Documentation requirements & evidence of conformity
ISO/IEC 42001 requires documented information proving the AIMS is designed, implemented, and improved effectively. This includes:
Annex A calls for documenting the impact assessment of AI systems across their lifecycle, including ethical and social dimensions.
The standard also requires training evidence (who was trained, on what, when), performance indicators/metrics, and records of internal audits and corrective actions, ensuring information is accurate, current, controlled, and readily available.
ISO 42001 vs ISO 27001 & NIST AI RMF
ISO/IEC 42001 (AIMS)
A management standard for AI. It sets requirements for responsible, transparent, and fair AI use, emphasizing governance, accountability, ethical/social impacts, bias control, and continuous lifecycle monitoring. It is the first international standard to formalize an AIMS.
ISO/IEC 27001 (ISMS)
A management standard for information security. It protects confidentiality, integrity, and availability via an ISMS with risk assessment, controls, and continual improvement.
NIST AI RMF
A voluntary AI risk-management framework structured around Govern, Map, Measure, Manage. It helps identify, assess, and reduce AI risks so systems are trustworthy, safe, fair, and controlled across their lifecycle.
Common ground / synergies:
All are risk-management-based with documented governance and continual improvement. ISO 27001 provides mature data security practices also needed for AI (e.g., protecting training/monitoring data).
Gaps / distinct aims:
ISO 27001 does not sufficiently cover bias, human oversight, algorithmic decision transparency, or social impact. ISO 42001 focuses precisely there—responsible AI use, AI supplier control, documented AI governance, and alignment with regulations like the EU AI Act. It complements rather than replaces ISO 27001.
Certification process: Stage 1, Stage 2, 3-year cycle, time & cost
ISO/IEC 42001 certification follows two stages, like other certifiable management standards.
- Stage 1 (readiness review): the auditor reviews AIMS documentation—AI policies, roles, risk assessment, AIAs, internal audits, and management review—to confirm readiness for a full evaluation.
- Stage 2 (effectiveness assessment): checks how AI works in practice: team interviews, sampled process checks, and evidence that controls for risk, bias, transparency, and compliance are applied. The two stages should occur close in time.
If approved, the certificate is issued with 3-year validity. Annual surveillance audits verify the AIMS is maintained and improved and that corrective actions are implemented. In year 3, a recertification audit renews the cycle.
Time and cost depend on:
(a) organization size and complexity,
(b) number of sites / geographic spread,
(c) AIMS scope (how many critical decisions involve AI),
(d) sectoral criticality (e.g., food/health),
(e) maturity of documentation and governance before the audit.
ISO/IEC 42001 readiness check
During the audit, the team verifies that the AIMS is defined, documented, implemented, and monitored. For ISO/IEC 42001, an internal AIMS audit and a management review must already be completed to demonstrate suitability, adequacy, and effectiveness before the external assessment.
The auditor expects, documented:
Q-Cert, as a certification body, does not provide implementation consulting. The above are items assessed for conformity to ISO/IEC 42001:2023.
Why Q-Cert?
Q-Cert approaches ISO/IEC 42001 with substantive experience. For years we have performed audits and certifications of Information Security Management Systems (ISO/IEC 27001) for high-criticality organizations, covering cybersecurity, data protection, and regulatory requirements.
In parallel, we are the only Greek accredited body conducting eIDAS conformity assessments of Qualified Trust Service Providers (QTSPs) under Regulation (EU) 910/2014 and related ETSI standards—where information security, legal compliance, and traceability are non-negotiable. This ongoing work with governance, risk management, and accountability is exactly the DNA of ISO 42001 for responsible AI.
Frequently Asked Questions (FAQ)
Q-CERT as a Certification Body
Q-CERT operates internationally across Europe, Asia, Africa, and the Americas, supporting organizations in multi-sector and multi-site projects. With experience in thousands of certifications and auditors specialized by industry, we apply transparent and impartial assessment procedures. Our methodology aligns with international best practices, ensuring clear documentation, timely communication, and a consistent time-to-decision.
Choosing Q-CERT for your ISO/IEC 42001:2023 certification ensures international recognition and demonstrates your organization’s commitment to responsible and transparent Artificial Intelligence governance, with documented risk management, ethical controls, and continuous improvement. The certification strengthens stakeholder trust and proves your compliance with the principles of responsible AI.
To obtain ISO/IEC 42001:2023 certification, contact Q-CERT and request a tailored offer.