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IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
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)?
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 comprises 21 controls organised across 6 domains, and applies in International.
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Browse the framework graph →Where IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) overlaps with the standards you already hold
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs ISO 27001:2022View comparison →IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs SOC 2View comparison →IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs NIST CSF 2.0View comparison →IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs GDPRView comparison →IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs HIPAAView comparison →IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) vs PCI DSS 4.0View comparison →
What IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) means in your sector
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Healthcare→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Financial Services→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Technology→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Government→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Manufacturing→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Energy→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Retail→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Education→
What IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) means for your job
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for CISOs→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Compliance Officers→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Risk Managers→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for IT Directors→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for DPOs→IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) for Auditors→
Questions people ask about IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
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)?
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.
How many controls does IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) have?
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) contains 21 controls organized across 6 domains.
Where does IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) apply?
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) applies in International. Organizations operating in or serving customers in this jurisdiction should check whether its requirements reach them.
Which version of IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) is covered here?
This page covers Global ACI TECH-3-007 (M) v1.0 (issued 10 July 2026, implemented 28 August 2026), carrying forward IAF MD 9:2023; IAF MD 9:2022 Issue 4 is the earlier edition.
Query IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) programmatically
IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485), its 21 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 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) API reference and MCP config →How ready are you for IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)?
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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .