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In the early
stages of the audit program the Quality Manager will play a key role in each
of the audits. As the program becomes more established the audits will be
conducted by staff from a pool of internal auditors.
Internal auditors are chosen and trained by the Quality Manager. Ideally the internal auditor should have an understanding of the QMS, knowledge of testing technologies, ability to analyse situations and good communication skills. Internal Auditor training should include observing a qualified auditor on an internal audit. In most cases this will be the Quality Manager. The newly trained internal auditor will conduct their first audit under the supervision of a trained auditor. Ideally, the Quality Manager has attended an internal audit training course to gain his own qualifications and knowledge of internal auditing Auditors must be independent of the area of which they will audit. For example, the head of Serology can not audit the Serology laboratory and the Quality Manager can not audit the internal audit section. Rather, the Quality Manager could audit the Serology laboratory and the head of Serology could audit the internal audit process. |