IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)

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)

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

What does MD 5.1.2 require?

The certification body puts in place agreements with its clients that permit it to release audit report information to the regulators that recognise ISO 13485.

Maintained by Gerard Blokdyk

Other controls in 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)

MD 5.2.3 Keep the body and its auditors clear of device, QMS and representative involvements that compromise impartiality

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485) controls