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IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
What is 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. It comprises 9 controls organised across 4 domains, and applies in International.
Map this against the frameworks you already hold
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Browse the framework graph →Where IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies overlaps with the standards you already hold
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies vs ISO 27001:2022View comparison →IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies vs SOC 2View comparison →IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies vs NIST CSF 2.0View comparison →IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies vs GDPRView comparison →IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies vs HIPAAView comparison →IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies vs PCI DSS 4.0View comparison →
What IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies means in your sector
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Healthcare→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Financial Services→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Technology→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Government→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Manufacturing→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Energy→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Retail→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Education→
What IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies means for your job
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for CISOs→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Compliance Officers→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Risk Managers→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for IT Directors→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for DPOs→IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies for Auditors→
Questions people ask about IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
What is 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.
How many controls does IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies have?
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies contains 9 controls organized across 4 domains.
Where does IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies apply?
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies applies in International. Organizations operating in or serving customers in this jurisdiction should check whether its requirements reach them.
Which version of IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies is covered here?
This page covers Global ACI TECH-3-006 (M) v1.0 (issued 10 July 2026, implemented 28 August 2026), carrying forward IAF MD 8:2023 Issue 5 (20 November 2023).
Query IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies programmatically
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies, its 9 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies API reference and MCP config →How ready are you for IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies?
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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .