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 9.1.2.1: Decide and record whether outsourced processes need specific audit team competence

What does MD 9.1.2.1 require?

Where the applicant uses outsourced processes, the certification body determines and documents whether the audit team needs specific competence to evaluate the client's control of those outsourced processes.

Maintained by Gerard Blokdyk

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