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The Lead Auditor should work with the Audit Team to prepare checklists for use in interviewing and observing, using QP1020-3 QUALITY AUDIT CHECKLIST (SAMPLE) for guidance. The Quality Audit Checklist ISO Template should be designed to reflect the activities and unique quality points in the area being audited. The Lead Auditor should review Audit Checklists and add questions he/she believes are necessary to adequately evaluate the implementation of the QMS in the area being audited.
When conducting interviews, Audit Team members should use the Quality Audit Checklist ISO Template to maintain focus and ensure completeness. There should be enough questions on the Checklist to enable a thorough evaluation of activities in the audited area; however, the Lead Auditor must recognize that Auditors may not have time to ask all questions. Auditors should: