4.3.1. Audits may be performed by a single individual or team either internally or externally, depending on the scope and duration of the audit.
4.3.2. Audits shall be performed by competent personnel independent of those who performed or directly supervised the activity being audited.
4.3.3. Auditors will develop internal audit checklist, TOMS-F-QI-02, as needed and use to assure consistency in evaluation and that important items are covered during audit. Internal audit checklist can be developed by reviewing related documentation, such as the Quality Manual, applicable procedures, codes, standards, previous audit reports, previous corrective action, and recommendations.
4.3.4. Objective evidence of audit shall be referred in audit report and/or relevant documents.