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 with too much work, creating an unacceptably high work pressure.	Activity
	Is the Quality Officer appointed as Internal Auditor?	Activity
	Have Internal Auditors been appropriately trained and certified?	Activity
	Is a Position Job Description present for the position of Internal Auditor?	Activity
	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?	Activity
	Does the Authorization Matrix include the tasks and responsibilities pertaining to the position of Internal Auditor?	Activity
	Have staff adequately been informed about what internal auditing is, why it is done, and who the Internal Auditors are?	Activity
	Are internal audits planned on a yearly basis and is this audit plan communicated to all the laboratory staff involved?	Activity
	Are internal audits carried out in such a way that the complete quality management system and all examinations are audited every 12 months?	Activity
	Are observations made during internal audits reported and are nonconformities identified and scored according to severity?	Activity
	Is the audit report submitted to laboratory management for translation into a SMART action plan to ensure correcting/solving of all the nonconformities noted?	Activity
	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?	Activity
	Is timely implementation of the action plans following internal audit monitored?	Activity
	Are Internal Audit Reports with action plans archived when all action points have been completed?	Activity
	Is the procedure for planning, conducting and processing internal audits standardized in an SOP?	Activity