IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
The mandatory accreditation criteria added to ISO/IEC 17011 for accrediting ISO 13485 certification bodies: medical device competence per function, risk-based witnessing at initial assessment and through the cycle, checks of certified manufacturers' public device information, scopes by technical area, and regulator feedback in records and management review.
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies is a compliance framework from International (IAF MLA and Global ACI Arrangement signatories) with 4 domains and 9 controls. The largest domains are Clause 7: Process requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies (5 controls), Annexes 1 and 2: Scopes of accreditation and required knowledge and skills – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies (2 controls), Clause 6: Resource requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies (1 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (4)
Annexes 1 and 2: Scopes of accreditation and required knowledge and skills – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
| Code | Title |
|---|---|
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::A1 | Use the Annex 1 technical areas for scopes, with detail, risk classification and intended purpose where a category is not specified |
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::A2 | Define the Annex 2 knowledge and skills per accreditation function |
Clause 6: Resource requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
| Code | Title |
|---|---|
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::MD 6.1.2 | Define the knowledge and skills of Annex 2 for each accreditation function |
Clause 7: Process requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
| Code | Title |
|---|---|
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::MD 7.14.1 | Keep regulatory authority concerns, opinions and feedback in the records on the certification body |
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::MD 7.4.5 | Sample initial witnessing to include a higher-risk audit in each main technical area |
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::MD 7.6.4 | Appraise certified manufacturers' public information and use it during assessment |
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::MD 7.8.3 | State the technical areas of Annex 1 in the scope on the accreditation certificate |
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::MD 7.9.3 | Run surveillance and reassessment with annual office and witness assessments covering every main technical area in the cycle |
Clause 9: Management system requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
| Code | Title |
|---|---|
| iaf-md-8-global-aci-tech-3-006-application-of-iso-iec-17011-for-accreditation-of-iso-13485-certification-bodies::MD 9.8 | Bring regulatory authority feedback into management review |
What is IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies and who does it apply to?
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies is a compliance framework from International (IAF MLA and Global ACI Arrangement signatories) with 4 domains and 9 controls. The mandatory accreditation criteria added to ISO/IEC 17011 for accrediting ISO 13485 certification bodies: medical device competence per function, risk-based witnessing at initial assessment and through the cycle, checks of certified manufacturers' public device information, scopes by technical area, and regulator feedback in records and management review. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies actually require?
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies has 9 controls organised across 4 domains. The largest domains are Clause 7: Process requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies (5 controls), Annexes 1 and 2: Scopes of accreditation and required knowledge and skills – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies (2 controls), Clause 6: Resource requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies (1 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 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies do I already cover?
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies 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 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies?
Start your IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies 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 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies 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 9 controls and track your progress.
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