Standards and Accreditation
A disciplined framework for independent conformity assessment
AIHRI's operating model is being structured around recognised principles for competence, impartiality, consistency, evidence and continuing oversight.
I. Two distinct authorities
Accreditation and certification are different
The two terms are often used interchangeably. They describe different functions performed by different bodies.
- Accreditation
- Formal recognition, by an accreditation body, of the competence of a conformity assessment body to perform defined activities within a defined scope.
- Certification
- The conformity decision made by a competent certification body about a defined service, process or other object within its authorised scope.
II. Primary reference
ISO/IEC 17065
ISO/IEC 17065 establishes requirements for bodies certifying products, processes and services. It addresses impartiality, competence, evaluation, review, decision, records, complaints and appeals.
Requirements for bodies certifying products, processes and services
Establishes requirements for impartiality, competence, evaluation, review, decision, records, complaints and appeals within a certification body.
III. Wider ecosystem
Supporting standards and frameworks
Relevance depends on the applicable scheme and scope. AIHRI does not claim to certify against every standard listed. Standards may inform competence, context or scheme requirements.
- ISO/IEC 17067Fundamentals of product certification and guidelines for certification schemesPrinciples for the design and operation of certification schemes.
- ISO 19011Guidelines for auditing management systemsReference for audit planning, conduct and auditor competence.
- ISO/IEC 42001Artificial intelligence management systemsReference for the management of AI systems within an organisation.
- ISO/IEC 23894Guidance on risk management for AIReference for the identification and treatment of AI-related risk.
- ISO/IEC 27001Information security management systemsReference for information security expectations in AI-enabled services.
- ISO 7101Healthcare organisation managementReference for quality management in healthcare organisations.
- ISO 31000Risk management guidelinesGeneral principles for organisational risk management.
- Applicable legislationHealthcare, data protection and AI lawStatutory requirements in the jurisdictions where certified services are provided.
IV. Current status
Accreditation pathway
AIHRI is pursuing accreditation under ISO/IEC 17065. Formal accreditation status and scope will be published following completion of the accreditation process.
Accredited certification services will commence only within the scope formally granted by the accreditation body.
V. Scope transparency
Where the formal scope will appear
Once accreditation is granted, the accreditation body, reference number, standard, formal scope, status and issue date will be published in the panel below, together with a link to the accreditation-body directory.
VI. Boundary
Certification does not replace
A certification decision, whether accredited or not, does not substitute for any of the following.
- Applicable law and competent authorities.
- Notified-body functions under applicable regulation.
- Medical-device conformity assessment.
- Healthcare licensing and inspection.
- Professional responsibility of clinicians and organisations.
VII. Continuing conformity
Standards integrity
AIHRI will maintain the procedures and records required to operate a credible certification function. These procedures are not accredited until the accreditation body has formally granted scope.
- Controlled procedures maintained under a defined document control system.
- Competence records for personnel involved in assessment, review and decision.
- Decision records that evidence the basis for each certification outcome.
- Complaints and appeals processes with independent review.
- Evidence of continuing conformity within the approved management system.