IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
Clause 9: Process 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 9.1.5: Never sample sites that design, develop or manufacture medical devices

What does MD 9.1.5 require?

Sites involved in the design, development or manufacture of medical devices (Annex A Tables A.1.1 to A.1.6) are not sampled in multi-site certification; each is audited.

Maintained by Gerard Blokdyk

Other controls in Clause 9: Process requirements – 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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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