IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
The mandatory accreditation criteria added to ISO/IEC 17021-1 for certifying medical device quality management systems to ISO 13485: regulatory compliance checks, impartiality, auditor and decision maker competence and experience, technical areas, audit time, no sampling of manufacturing sites, scope precision, major nonconformities, vigilance review in surveillance and unannounced audits.
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) is a compliance framework from International (IAF MLA and Global ACI Arrangement signatories) with 6 domains and 21 controls. The largest domains are Clause 9: Process requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) (8 controls), Annexes A to D: Technical areas, knowledge and skills, auditor qualification, audit time – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) (4 controls), Clause 7: Resource requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) (4 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (6)
Annexes A to D: Technical areas, knowledge and skills, auditor qualification, audit time – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
| Code | Title |
|---|---|
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::A | Use the Annex A technical areas to define scope, identify technical qualification needs and select the team |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::B | Define the Annex B knowledge and skills per certification function and apply the parts and services test |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::C | Qualify auditors by education, four years' experience, Annex B competence and continuing development |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::D | Start initial audit time from Table D.1 and adjust it within the stated limits |
Clause 4: Principles – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
| Code | Title |
|---|---|
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 4.4.1 | Determine that the client has evaluated regulatory compliance and acted on non-compliance |
Clause 5: General requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
| Code | Title |
|---|---|
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 5.1.2 | Hold client agreements that allow audit report information to go to regulators recognising ISO 13485 |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 5.2.3 | Keep the body and its auditors clear of device, QMS and representative involvements that compromise impartiality |
Clause 7: Resource requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
| Code | Title |
|---|---|
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 7.1.1 | Treat the scheme as medical devices and applicable law, and meet the Annex B competence requirements |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 7.2.4 | Demonstrate auditor competence per Annex C and authorise auditors by Annex A technical area |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 7.2.5 | Require supervised audit experience before first authorisation, more for team leaders |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 7.2.8 | Ensure the certification decision makers collectively meet Annex B competence |
Clause 8: Information requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
| Code | Title |
|---|---|
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 8.1.3 | Give regulators information on certifications granted, suspended or withdrawn where the law or the authority requires |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 8.2.1 | Document the scope precisely and exclude nothing that affects product safety and quality |
Clause 9: Process requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
| Code | Title |
|---|---|
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.1.2.1 | Decide and record whether outsourced processes need specific audit team competence |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.1.4 | Set audit time from Annex D and the TECH-3-004 rules, with regulatory and dossier time added, and justify it |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.1.5 | Never sample sites that design, develop or manufacture medical devices |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.2.2.1 | Field a team competent for the technical area, with sterilisation competence where devices are sterile |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.3.1 | Avoid repeating audit work already done under a regulatory scheme that covers ISO 13485, and hold stage 1 on site for higher-risk devices |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.4.5 | Classify as major the nonconformities that need accepted and verified corrective action |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.6.2.2 | Review adverse event notifications, advisory notices and recalls in surveillance |
| iaf-md-9-global-aci-tech-3-007-application-of-iso-iec-17021-1-for-medical-device-quality-management-system-certification-iso-13485::MD 9.6.4.2 | Hold short-notice or unannounced audits when devices, safety information, significant changes or the law call for them |
What is IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) and who does it apply to?
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) is a compliance framework from International (IAF MLA and Global ACI Arrangement signatories) with 6 domains and 21 controls. The mandatory accreditation criteria added to ISO/IEC 17021-1 for certifying medical device quality management systems to ISO 13485: regulatory compliance checks, impartiality, auditor and decision maker competence and experience, technical areas, audit time, no sampling of manufacturing sites, scope precision, major nonconformities, vigilance review in surveillance and unannounced audits. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) actually require?
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) has 21 controls organised across 6 domains. The largest domains are Clause 9: Process requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) (8 controls), Annexes A to D: Technical areas, knowledge and skills, auditor qualification, audit time – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) (4 controls), Clause 7: Resource requirements – IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) do I already cover?
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)?
Start your IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 21 controls and track your progress.
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