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Assessment Model

Structured, proportionate and evidence-led

AIHRI's assessment model is designed to connect defined requirements, competent evaluation, independent review and continuing oversight.

Depending on the applicable certification scheme, scope and risk profile, specific activities, sequencing and evidence expectations may vary. This page describes the general model.

I. Lifecycle overview

A defined sequence, calibrated to scope

The lifecycle groups activities into engagement, planning, assessment, decision, post-decision oversight and independent redress. The diagram below is illustrative; the ordered stage list beneath is the canonical reference.

Ordered stage sequence

  1. Stage 1. Enquiry and eligibility

    Initial contact and confirmation that the requested object and scope fall within AIHRI's assessment remit.

  2. Stage 2. Application and scope review

    Formal application, definition of the services and boundaries proposed for assessment and confirmation that competence is available.

  3. Stage 3. Risk profiling

    Structured profiling of clinical, technical and organisational risk to shape assessment depth, sampling and team composition.

  4. Stage 4. Competence-based team allocation

    Assignment of assessors whose combined competence matches the specific scope, with conflicts of interest reviewed and recorded.

  5. Stage 5. Assessment planning

    Documented plan setting objectives, evidence expectations, activities, interfaces and timing.

  6. Stage 6. Remote assessment where applicable

    Confirmation of scope, documented readiness, governance structure and assessment planning through documentary review and structured interviews.

  7. Stage 7. On-site assessment where applicable

    Verification of actual implementation, workflows, interviews, technical controls and evidence in operational context.

  8. Stage 8. Findings and corrective actions

    Objective findings, classification of nonconformity, agreed corrective actions and verification of resolution.

  9. Stage 9. Independent technical review

    Review of the assessment record by personnel independent of the assessment team for completeness and adequacy.

  10. Stage 10. Certification decision

    Decision to grant, refuse, maintain, reduce, suspend, withdraw or reinstate certification, taken by a competent decision-maker separate from the assessment team.

  11. Stage 11. Attestation

    Issuance of the formal attestation reflecting the decision, defined scope and applicable conditions.

  12. Stage 12. Surveillance and reassessment

    Planned surveillance, material-change review and periodic reassessment across the certification cycle.

  13. Stage 13. Appeals and complaints

    Independent handling of appeals against decisions and of complaints about AIHRI's conduct or service.

II. Selection and scope review

Deciding whether the engagement can be accepted

Before assessment activities begin, AIHRI reviews whether the requested object and scope are eligible under an applicable certification scheme, whether the necessary competence is available, whether any conflict of interest exists and whether the engagement can be accepted on the proposed terms.

Where an engagement cannot be accepted, the reason is documented and communicated to the applicant.

III. Risk profiling and planning

Factors that shape assessment depth

Intended use, clinical influence, deployment context, organisational complexity, sites and technical integration inform assessment depth, sampling and team composition. AIHRI does not publish a proprietary risk score or a fixed category system.

Intended use
The clinical purpose the AI-enabled service is designed to support.
Clinical influence
The extent to which AI outputs shape clinical decisions or actions.
Deployment context
The setting, population and workflow in which the service operates.
Organisational complexity
Governance arrangements, functions and lines of responsibility involved.
Sites
Number and distribution of sites where the service is delivered.
Technical integration
Integration with clinical, data and information-security systems.

IV. Multidisciplinary team allocation

Distinct contributions, defined roles

A team is composed so that the necessary competence is present across the scope. Individuals contribute within their defined competence.

Lead Auditor
Plans and leads the assessment, integrates evidence across domains and manages the assessment record.
Clinical Domain Expert
Contributes clinical perspective on intended use, workflow integration and human oversight.
AI Technical Expert
Contributes technical perspective on model behaviour, performance monitoring and change control.
Information Security Specialist
Where required, contributes on data protection, information-security controls and technical assurance.
Other scope-specific expertise
Additional competence engaged where the scope requires it.

Technical and clinical experts contribute within their defined competence. They do not independently determine conformity unless separately authorised for a decision role.

V. Remote and on-site assessment

Different modes, different purposes

Remote and on-site assessment serve complementary purposes. Their combination is defined in the assessment plan.

Remote assessment
May confirm scope, documented readiness, governance structure and assessment planning through documentary review, structured interviews and controlled evidence exchange.
On-site assessment
May verify actual implementation, workflows, interviews, technical controls and evidence in operational context.

Remote assessment does not substitute for on-site verification where on-site evidence is necessary.

VI. Findings and corrective actions

Objective findings, verified correction

  1. Findings are objective and traceable to defined requirements and observed evidence.

  2. Nonconformities are classified according to their nature and effect.

  3. The organisation determines and implements corrective action.

  4. AIHRI verifies the adequacy and effectiveness of corrective action; it does not design or deliver the solution.

VII. Independent review and certification decision

Separation within a single case

For any given case, the three functions below are performed by different personnel. The decision function is independent of the assessment team.

  1. The assessment team gathers and evaluates evidence.
  2. An independent reviewer evaluates completeness and adequacy.
  3. A competent decision-maker grants, refuses, maintains, reduces, suspends, withdraws or reinstates certification within authorised scope.

Assessment team

Gathers and evaluates evidence against defined requirements.

Output

Assessment record and findings.

Independent reviewer

Evaluates completeness and adequacy of the assessment record.

Output

Review conclusion.

Decision-maker

Grants, refuses, maintains, reduces, suspends, withdraws or reinstates certification within authorised scope.

Output

Certification decision.

VIII. Attestation and scope

Scope-specific, time-bound, evidence-based

Where a certification decision is positive, the attestation reflects the specific scope assessed, the period for which it is valid and the continuing conditions on which it depends. Attestation is not a general endorsement of the organisation or of any product.

IX. Surveillance and reassessment

Continuing oversight across the cycle

Certification is not a single event. Continuing oversight tests whether the conditions of conformity are maintained in operation.

Planned surveillance
Scheduled activities across the certification cycle to verify continuing conformity.
Material-change review
Assessment of changes to the service, organisation, technology or context that may affect conformity.
Periodic reassessment
A structured reassessment against the current requirements at defined intervals.
Scope, suspension and withdrawal
Where conditions are not maintained, scope may be changed, or certification suspended or withdrawn.

X. Appeals and complaints

Two distinct channels

Appeals and complaints are handled through separate procedures. Both are addressed independently of the personnel who conducted the original assessment and decision.

Appeal
An appeal challenges a certification decision or a procedural outcome. Appeal review is independent of the original assessment and decision.
Complaint
A complaint expresses dissatisfaction about AIHRI's conduct, service or another matter, and is handled through the complaints procedure.

XI. Applicant rights and responsibilities

A balanced relationship

Certification depends on a clear allocation of rights and responsibilities between AIHRI and the applicant organisation.

Applicant rights

Confidentiality
Assessment information is handled with defined confidentiality controls.
Equal access
Access to assessment services is offered without unfair discrimination within stated scope.
Clear findings
Findings are stated in writing with the basis of the conclusion.
Right to appeal
Applicants may appeal certification decisions and procedural outcomes.

Applicant responsibilities

Accurate information
Provide complete and accurate information about the service and organisation.
Access to evidence
Provide reasonable access to sites, personnel, records and systems within scope.
Report material changes
Notify AIHRI of changes that may affect continuing conformity.
Comply with conditions
Meet surveillance conditions and any specific requirements attached to certification.

Continue

Governance and standards

The assessment model operates within AIHRI's governance framework and against defined standards. For scope-specific enquiries, contact the Institute.

Governance →Standards →Contact →