ISO 42001 Checklist

Use this ISO 42001 Audit Checklist to assess AIMS compliance, AI lifecycle controls, for an internal audit and gap analysis against the ISO IEC 42001 standard.

ISO 42001 Checklist



Clause 4 — Context Of The Organization

1. The organization has documented the external issues relevant to its AIMS, including applicable AI regulations, industry standards, and market expectations.


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2. Internal issues affecting the AIMS are documented, including organizational culture, existing governance structures, and resource capabilities.


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3. Interested parties relevant to the AIMS are identified, including customers, users, regulators, employees, and third-party AI vendors.


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4. The requirements and expectations of each interested party are documented and reviewed periodically.


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5. The AIMS scope statement is documented, clearly defining which AI systems, activities, and organizational units are covered.


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6. AI systems included within scope are identified by name, function, and the organization's role (developer, provider, or deployer).


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7. Any AI systems excluded from scope are listed with documented justification.


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8. The AIMS scope is available to relevant interested parties.


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9. An AI system inventory is maintained and aligned to the documented scope.


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10. The AI system inventory includes system purpose, owner, operational status, and data inputs for each entry.


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Clause 5 — Leadership And AI Policy

1. Top management has demonstrated commitment to the AIMS through documented resource allocation decisions and governance approvals.


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2. Evidence of leadership involvement in AIMS establishment is available, such as steering committee records, approval sign-offs, or management review minutes.


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3. An AI policy is documented and approved by top management.


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4. The AI policy includes a commitment to responsible and ethical AI development and use.


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5. The AI policy provides a framework for setting AI objectives and includes a commitment to continual improvement.


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6. The AI policy is communicated to all personnel involved in AI activities.


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7. The AI policy is available to relevant external parties where appropriate.


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8. AIMS roles, responsibilities, and authorities are documented and assigned.


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9. Responsibility for ensuring AIMS conformity is formally assigned to a named role or individual.


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10. Responsibility for reporting AIMS performance to top management is formally assigned.


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11. Evidence that AIMS responsibilities have been communicated to relevant personnel is available.


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Clause 6 — AI Risk Assessment And Planning

1. An AI risk assessment process is documented, including risk identification, analysis, evaluation, and treatment steps.


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2. Risk criteria are defined, including AI-specific criteria such as bias potential, explainability requirements, and societal impact thresholds.


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3. Risk assessments have been completed for all AI systems within scope.


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4. Risk assessments are reviewed and updated when AI systems undergo significant changes.


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5. A risk register is maintained with risk owners, risk levels, and treatment status for each identified risk.


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6. Risk treatment options have been selected for each identified risk, with documented rationale.


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7. A Statement of Applicability (SoA) is documented, listing applicable Annex A controls with justifications for inclusions and exclusions.


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8. A risk treatment plan is documented with assigned owners and target completion dates.


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9. An AI impact assessment process is documented, covering intended use cases and foreseeable misuse scenarios.


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10. Impact assessments have been completed for AI systems with potential to affect individuals or society.


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11. Impact assessment results are retained and reviewed when system purpose or deployment context changes.


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12. AI objectives are established, documented, measurable, and consistent with the AI policy.


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13. Plans to achieve AI objectives include assigned responsibilities, required resources, timelines, and evaluation methods.


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14. A change management process is documented for planned changes to the AIMS, including changes to AI systems, data sources, or use cases.


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Clause 7 — Support: Resources, Competence, And Documentation

1. Resources required to establish, implement, and maintain the AIMS are determined and provided.


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2. Budget allocation for AIMS activities is visible and documented.


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3. Competence requirements are defined for all roles that affect AI system performance, safety, or governance.


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4. Evidence of competence is available for personnel in AIMS roles, such as qualifications, training records, or assessed performance.


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5. Training records are maintained where competence was developed through formal training.


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6. Evidence that training effectiveness has been evaluated is available.


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7. Personnel involved in AI activities are aware of the AI policy and their contribution to AIMS objectives.


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8. Internal and external communication requirements for the AIMS are documented, specifying who communicates what, to whom, and by which channel.


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9. A document control procedure is in place covering creation, approval, version control, and access management.


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10. AIMS documents are properly identified, described, and protected from unauthorized changes.


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11. Retention and disposal requirements for AIMS documented information are defined.


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12. Documented information is accessible to those who need it and protected from unintended alteration or deletion.


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Clause 8 — Operation

1. Operational procedures are documented for AI system design, development, testing, deployment, monitoring, and decommissioning.


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2. Criteria for controlling AI lifecycle processes are established and applied consistently.


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3. Evidence that AI lifecycle processes are executed according to documented procedures is available.


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4. AI risk assessments are performed at the design stage before new AI systems are deployed.


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5. AI risk assessments are repeated following significant changes to model architecture, training data, use case, or deployment environment.


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6. Change control records document approvals for model updates, prompt changes, retraining runs, and vendor changes.


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7. Rollback procedures are defined and tested for AI systems where reverting to a prior version may be required.


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8. Human oversight mechanisms are defined for AI systems where automated decisions carry material risk to individuals or the organization.


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9. Human review and override records are maintained for AI systems with defined oversight requirements.


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10. Model performance is tested against defined criteria before deployment, including accuracy, robustness, and intended-use alignment.


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11. Post-deployment monitoring is in place to detect model drift, performance degradation, and unexpected outputs.


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12. Monitoring results and incidents are recorded and reviewed at defined intervals.


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13. AI-specific incident response procedures are documented and cover detection, containment, root cause analysis, and notification.


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14. Records of AI incidents and near-misses are maintained and used to inform corrective action.


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Clause 9 — Performance Evaluation And Internal Audit

1. The organization has determined what to monitor and measure for AIMS performance, including AI system outcomes, risk treatment effectiveness, and objective progress.


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2. Methods, frequency, and responsibility for monitoring and measurement are documented.


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3. Monitoring results are analyzed, evaluated, and reported to relevant management at defined intervals.


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4. An internal audit program is documented, covering audit scope, criteria, frequency, and auditor selection.


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5. Auditor independence from the areas being audited is ensured and documented.


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6. At least one complete internal AIMS audit cycle has been completed before the certification audit.


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7. Internal audit reports document findings, evidence reviewed, conformities, and nonconformities.


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8. Audit findings are communicated to relevant management and tracked to closure.


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9. Management reviews are conducted at planned intervals by top management.


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10. Management review inputs include AIMS performance data, audit results, risk register status, objective progress, and changes in internal or external context.


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11. Management review outputs include decisions on improvement opportunities, resource needs, and any required changes to the AIMS.


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12. Management review minutes are retained as documented evidence.


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Clause 10 — Improvement And Corrective Action

1. A process for identifying, recording, and managing nonconformities is documented.


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2. Nonconformities, including AI system control failures and incidents, are recorded when they occur.


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3. Root cause analysis is performed for each nonconformity to identify the underlying cause rather than the symptom.


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4. Corrective actions are planned with assigned owners and target completion dates.


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5. Corrective actions are verified for effectiveness before the nonconformity is closed.


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6. Records of nonconformities, corrective actions, and closure evidence are retained.


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7. Lessons learned from nonconformities and AI incidents are used to update risk assessments, controls, and procedures.


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8. Improvement opportunities are identified through monitoring results, audit findings, management reviews, and incident analysis.


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9. Evidence of continual improvement activities is available, demonstrating that the AIMS is developed over time rather than maintained as a static system.


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10. Improvement actions are tracked and their outcomes reported at management reviews.


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A.2.2 — AI Policy

1. A written AI policy is documented and approved at the appropriate management level, setting out the organisation's approach to developing, providing, and using AI systems.


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2. The AI policy is informed by the organisation's business strategy, values, risk appetite, legal obligations, and the risk environment relevant to its AI activities.


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3. The AI policy includes principles that guide all AI-related activities and processes for handling exceptions to those principles.


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4. Evidence is available that the AI policy genuinely shapes decision-making about AI systems, rather than existing solely as a document.


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A.2.3 — Alignment With Other Organisational Policies

1. The organisation has identified all existing policies — including information security, privacy, risk management, HR, procurement, and ethics — that intersect with AI activities.


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2. The AI policy is consistent with those existing policies, with conflicts identified and resolved through policy updates rather than left unaddressed.


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3. Where AI activities introduce requirements not covered by existing policies, the AI policy or relevant existing policies have been updated to address them.


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A.2.4 — Review Of The AI Policy

1. A named, management-approved role is responsible for the periodic review of the AI policy.


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2. The AI policy is reviewed on a planned cycle and whenever material changes occur, including new regulations, new AI use cases, changes in organisational context, or lessons learned from incidents.


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3. Review outcomes — including any resulting policy changes — are documented and retained as records.


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A.3.2 — AI Roles And Responsibilities

1. AI-specific roles and responsibilities are defined and documented, covering the full AI system life cycle — including risk management, impact assessment, development, oversight, data quality, security, and supplier management.


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2. Accountability and responsibility for each AI-related activity are explicitly assigned to named roles, with no gaps in coverage.


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3. AI roles and responsibilities are communicated to relevant personnel and reflected in organisational structures.


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A.3.3 — Reporting Of Concerns Regarding AI Systems

1. A formal mechanism exists for personnel, contractors, and relevant external parties to raise concerns about the organisation's development, provision, or use of AI systems.


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2. The reporting mechanism is accessible, confidential where appropriate, and protected from retaliation.


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3. Defined investigation and escalation steps are documented for concerns raised through this mechanism, and records of concerns raised and their resolution are retained.


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A.4.2 — Resource Documentation

1. An inventory of resources required by each AI system across its life cycle is maintained, covering data, tooling, system and computing resources, and human expertise.


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2. The resource inventory is kept current as AI systems are developed, modified, deployed, or decommissioned.


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A.4.3 — Data Resources

1. Documentation is maintained for every dataset used by AI systems, covering provenance, last-updated timestamps, categories (training, validation, test, production), labelling process, intended purpose, quality characteristics, retention policy, and known bias issues.


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2. Data resource documentation is sufficient to support impact assessment, risk assessment, and incident investigation for each AI system.


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A.4.4 — Tooling Resources

1. The algorithms, machine learning models, frameworks, libraries, optimisation methods, evaluation methods, and provisioning tools used by each AI system are documented.


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2. Tooling resource documentation is sufficient to support reproducibility of results and assessment of supply chain risk.


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A.4.5 — System And Computing Resources

1. The compute, storage, network, and hosting environments (on-premises, cloud, or edge) on which each AI system depends are documented, including capacity constraints, network and storage dependencies, and environmental impact of the hardware.


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A.4.6 — Human Resources

1. The people and competencies involved across every phase of each AI system's life cycle are documented, including developers, operators, domain experts, testers, oversight roles, and those responsible for change management.


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2. Diversity of expertise — including, where relevant, demographic representation in teams working with datasets affecting particular communities — is considered in human resource planning for AI activities.


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A.5.2 — AI System Impact Assessment Process

1. A documented, repeatable process is established and maintained for assessing the potential impacts of AI systems on individuals, groups, and society.


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2. The impact assessment methodology is defined, consistently applied across different AI systems, and capable of being scaled to the risk profile of each system.


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A.5.3 — Internal Impact Assessment Of AI Systems

1. Impact assessments have been conducted for each AI system within the AIMS scope using the process established under A.5.2.


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2. Impact assessments examine potential discriminatory outcomes, privacy violations, safety risks, and broader societal effects, and their results are used to inform deployment decisions and control selection.


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3. AI systems assessed as high-impact have corresponding controls in place; deployment without adequate controls following a high-impact assessment is documented as a nonconformity.


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A.5.4 — Functionality And Behaviour Of The AI System

1. Controls are in place to ensure AI systems function as intended and that deviations from expected behaviour are detected and addressed.


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2. Actual AI system behaviour is monitored against the outcomes of impact assessments conducted under A.5.3, with discrepancies investigated and acted upon.


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A.6.1.1 — Design Of The AI System

1. Requirements and design specifications are documented before AI system development begins, reflecting the intended use case, identified risks, and governance constraints established by the AI policy.


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2. Design documentation is sufficient to trace whether downstream controls are coherent with the system's original intent.


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A.6.1.2 — Data For Development And Enhancement

1. Governance controls are in place for data used in AI system development, covering privacy and security implications, security and safety threats from data-dependent development, transparency and explainability requirements, representativeness of training data relative to the operational domain, and data accuracy and integrity.


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A.6.1.3 — AI System Development Documentation

1. Documentation is maintained throughout the development process capturing design decisions, testing procedures, validation results, and changes, creating an audit trail demonstrating the system was built in accordance with its specifications and governance requirements.


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A.6.1.4 — Addressing Bias In Data

1. Explicit controls are in place for identifying, assessing, and addressing bias in training and operational data.


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2. Bias assessment results are documented, and corrective actions taken in response to identified bias are recorded and verified for effectiveness.


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A.6.1.5 — Robustness Of AI Systems

1. Robustness testing is conducted to verify that AI systems maintain intended performance under adversarial conditions, edge cases, and unexpected or manipulated inputs.


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2. Robustness testing is distinct from functional testing and its results are documented and retained.


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A.6.2.1 — AI System Operational Concept

1. Documentation of how each AI system is intended to operate in its deployment environment is maintained, covering users, use cases, interfaces, and operational constraints, defining what correct operation looks like for monitoring purposes.


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A.6.2.2 — AI System Testing

1. Structured testing is conducted before deployment to verify that each AI system performs as specified, with documentation covering scope, methodology, test data, results, and sign-off.


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2. Testing scope is demonstrably adequate relative to the risk profile of each system.


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A.6.2.3 — Human Oversight Of AI Systems

1. Human oversight mechanisms are defined for AI systems, including reviewers with genuine authority to override AI decisions, monitoring of AI output accuracy and consistency, and mechanisms for personnel to report concerns about AI outputs.


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2. The appropriateness of automated decision-making is assessed for each specific use case, and rubber-stamp oversight without ability to challenge outputs is not accepted as conforming to this control.


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A.6.2.4 — AI System Event Logs

1. Logging of AI system use is in place, capturing time, date, production data processed, and outputs that fall outside intended operational ranges.


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2. Logs are retained for as long as required by the system's intended use and applicable legal or regulatory requirements.


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A.6.2.5 — AI System Deployment

1. A documented deployment plan and formal verification process confirms that all necessary requirements — including design specifications, testing results, impact assessments, oversight mechanisms, and operational documentation — are in place before each AI system goes live.


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2. Evidence of deployment verification is retained for each AI system deployed within the AIMS scope.


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A.7.2 — Data For Development And Enhancement Of AI System

1. Operational data management controls are in place covering privacy and security in data use, security threats from data-dependent AI, transparency and explainability aspects, representativeness of training data versus the operational domain, and data accuracy and integrity.


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A.7.3 — Acquisition Of Data

1. Governance of how data is sourced covers categories required, quantities, data sources, source characteristics, data subject demographics, prior handling, data rights (including personal data and intellectual property), metadata about labelling, and provenance.


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2. Data acquisition records are maintained and sufficient to support regulatory compliance and incident investigation.


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A.7.4 — Quality Of Data

1. Data quality criteria — covering accuracy, completeness, consistency, and timeliness — are defined for datasets used by AI systems.


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2. Processes are established to detect and remediate data quality issues throughout the AI system life cycle, with quality assessment results documented and retained.


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A.7.5 — Processing Of Personal Information

1. Controls are in place for the appropriate handling of personal data within AI systems, aligned with applicable privacy frameworks and integrated with the organisation's existing privacy governance arrangements.


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A.8.2 — Transparency Of AI Systems

1. Documented information about each AI system — including its intended use, known limitations, performance characteristics, and governance arrangements — is made available to relevant interested parties in a form appropriate to the audience.


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A.8.3 — Communication About Intended Use Of AI System

1. The intended use of each AI system is communicated to users and affected individuals, including the circumstances under which the system operates and the basis on which outputs are generated.


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2. Where AI is used to make or significantly influence decisions affecting individuals, those individuals are informed of this fact through defined disclosure mechanisms.


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A.8.4 — Disclosure Of AI Interaction

1. Mechanisms are in place to disclose to individuals when they are interacting with an AI system, where this is required by applicable regulation, contractual obligation, or the organisation's own AI policy.


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2. Disclosure requirements are documented for each applicable AI system and their implementation is verified.


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A.9.2 — Intended Use

1. Each AI system is used only for its documented intended purpose, and controls are in place to detect and prevent use outside that purpose.


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2. Policies defining proper AI system applications and preventing misuse are documented, communicated to users, and reviewed at defined intervals.


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A.9.3 — Correct And Ethical Use

1. Controls are in place to ensure AI systems are used correctly and ethically in accordance with the organisation's AI policy and applicable ethical principles.


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2. Personnel using AI systems are trained on correct and ethical use requirements relevant to their role.


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A.9.4 — Information Security For AI Systems In Use

1. Information security controls applicable to AI systems during operation — including access controls, encryption, vulnerability management, and incident response — are identified and implemented.


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A.9.5 — Safety Of AI Systems In Use

1. Safety controls are in place for AI systems where outputs or failures could result in physical, psychological, financial, or societal harm to individuals or groups.


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2. Safety control requirements are determined through the impact assessment process (A.5.3) and are proportionate to the identified risk level.


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A.9.6 — Decommissioning Of AI Systems

1. A documented decommissioning process is in place for AI systems that are retired or replaced, covering secure disposal of data and models, update of the AI system inventory, communication to affected users, and retention of relevant records.


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A.10.2 — Responsible Use Policies In Third-Party Relationships

1. Contracts or agreements with third parties involved in AI activities — including suppliers, partners, and customers — include provisions covering responsible use of AI, data protection, incident notification, and compliance with applicable AI requirements.


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2. Third-party AI governance practices are assessed before engagement and at defined intervals, with documented outcomes and follow-up actions.


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A.10.3 — Customer Responsibilities

1. Where customers use the organisation's AI systems, their responsibilities for correct and safe use are clearly defined, communicated, and agreed in service agreements or equivalent documentation.


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A.10.4 — Third-Party AI Systems

1. An inventory of third-party AI systems and components used within in-scope AI systems is maintained and kept current.


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2. Third-party AI systems are assessed for risk before adoption and reviewed at defined intervals or following material changes to the supplier's service, model, or data practices.


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3. Procedures are in place to assess and approve third-party model updates, API changes, or retraining events that could affect in-scope AI system behaviour.


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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