Top management must ensure their personnel have the independence and authority necessary to perform these tasks.
Personnel who manage, perform, and assess work affecting quality, must have the independence and authority necessary to perform these tasks.
Audit – systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
US FDA 21 CFR 820.3(t)
Quality audit means a systematic, independent examination of a manufacturer's quality system...
ISO 13485:2003 clause 8.2.2 Internal audit
Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
US FDA 21 CFR 820.22 Quality audit
Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.
US FDA 820.30 Design controls (e) Design review. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. DESIGN VALIDATION
IEC 62366:2007 (EN 62366:2008), 5.9 Usability Validation
The manufacturer shall validate usability of the medical device according to the Usability Validation Plan. The results shall be recorded in the Usability Engineering File.
NOTE 4 – Individuals that were not directly responsible for the User Interface design should be involved in the usability validation.