Checklist Phase 3 - Assessment

Is an appropriate number of staff members appointed as Internal Auditors?

With appropriate is meant that the number of staff members appointed as Internal Auditors is sufficient to achieve auditing of the complete quality management system and all the examinations every 12 months, without overburdening the Internal Auditors, creating an unacceptably high work pressure.

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Is the Quality Officer appointed as Internal Auditor?

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Have Internal Auditors been appropriately trained and certified?

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Is a Position Job Description present for the position of Internal Auditor?

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Have the Personal Job Descriptions of the staff members appointed as Internal Auditors been adapted to include the tasks and responsibilities for their position as Internal Auditor?

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Does the Authorization Matrix include the tasks and responsibilities pertaining to the position of Internal Auditor?

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Have staff adequately been informed about what internal auditing is, why it is done, and who the Internal Auditors are?

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Are internal audits planned on a yearly basis and is this audit plan communicated to all the laboratory staff involved?

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Are internal audits carried out in such a way that the complete quality management system and all examinations are audited every 12 months?

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Are observations made during internal audits reported and are nonconformities identified and scored according to severity?

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Is the audit report submitted to laboratory management for translation into a SMART action plan to ensure correcting/solving of all the nonconformities noted?

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Are action plans made to solve/correct the nonconformities identified in internal audits with corrective actions, control steps and preventive actions when necessary and applicable?

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Is timely implementation of the action plans following internal audit monitored?

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Are Internal Audit Reports with action plans archived when all action points have been completed?

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Is the procedure for planning, conducting and processing internal audits standardized in an SOP?

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