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 7.2.8: Ensure the certification decision makers collectively meet Annex B competence

What does MD 7.2.8 require?

The people who take the certification decision, as a group or an individual, meet the competence of Annex B; in a group not every individual needs every requirement, but the group as a whole does, and an individual who decides alone meets them all.

Maintained by Gerard Blokdyk

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