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

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

What does MD 7.1.1 require?

Where clause 7.1.1 of ISO/IEC 17021-1 speaks of what is relevant to the particular certification scheme, for ISO 13485 this should be read as medical devices and the applicable legal requirements, and everyone involved in ISO 13485 certification meets the competence requirements of Annex B.

Maintained by Gerard Blokdyk

Other controls in 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)

Query this from an agent

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

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