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

Clause 8: Information 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System Certification (ISO 13485) MD 8.1.3: Give regulators information on certifications granted, suspended or withdrawn where the law or the authority requires

What does MD 8.1.3 require?

Where the law or the relevant regulatory authority requires it, the certification body provides the regulatory authority with information about certifications it has granted, suspended or withdrawn.

Maintained by Gerard Blokdyk

Other controls in Clause 8: Information 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 8.2.1 Document the scope precisely and exclude nothing that affects product safety and quality

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 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