IAF MD 9 / Global ACI TECH-3-007 Application of ISO/IEC 17021-1 for Medical Device Quality Management System Certification (ISO 13485)
Clause 5: General 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 5.2.3: Keep the body and its auditors clear of device, QMS and representative involvements that compromise impartiality

What does MD 5.2.3 require?

The certification body and its auditors are impartial and free of engagements and influences that could affect their objectivity: they are not involved in designing, making, constructing, marketing, installing, servicing or supplying the medical device or its parts and services; not involved in designing, building, implementing or maintaining the quality management system under audit; and not acting as the client's authorised representative or representing parties engaged in those activities. Impartiality is compromised, for example, where an auditor holds a financial interest in the client, is currently employed by a manufacturer of similar or competing devices, or is a researcher, clinician or consultant with a commercial contract or similar interest with makers of similar devices.

Maintained by Gerard Blokdyk

Other controls in Clause 5: General 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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