Checklist Assessment

Has the laboratory formulated quality controls to guard the quality of each process step in each procedure?

Activity

Are internal quality control results recorded in a register?

Activity

Are internal quality control protocols included in all relevant SOPs?

Activity

Does the laboratory have an SOP for Internal Quality Control that contains:

  • An explanation on the concept of internal quality control
  • The general procedure for performing an internal quality control
  • Procedure for developing internal quality control materials
  • The procedure for periodic review of internal quality controls
  • The procedure to follow when an internal quality control fails

Activity

Does the laboratory monitor internal quality control results and act on quality control failures?

Activity

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.

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

Has an external audit been performed to verify complete and correct implementation of the quality management system in compliance with ISO 15189 before the laboratory applies for accreditation?

Activity

Are internal quality control results continuously monitored?

Activity

Does the laboratory undertake action as soon as possible to solve internal quality control failures/deviations from trends?

Activity

Is reporting of results halted when internal quality controls deviate/fail?

Activity

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

Activity

Are action plans made to solve/correct the nonconformities identified in the external mock audit with corrective actions and control steps and preventive actions when necessary and applicable?

Activity

Is timely implementation of the action plans following the external mock audit monitored?

Activity

Is the audit report of the external mock audit with the action plan archived when all action points have been completed?

Activity

Does the laboratory participate in proficiency testing/inter-laboratory comparison schemes for all the examinations performed?

Activity

If participation in a proficiency testing scheme or organization of an inter-laboratory comparison for a certain test is not possible: does the laboratory have a rechecking/retesting system to compare results?

Activity

If results of proficiency testing/inter-laboratory comparisons are deviating/incorrect, does the laboratory act with performing an analysis to identify the causes of the problem and does it implement corrective actions, and, if possible, preventive actions?

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

Does the laboratory have an SOP for participation in a proficiency testing scheme and/or an inter-laboratory comparison scheme?

Activity

If the laboratory is the organizer of an inter-laboratory comparison scheme, does the SOP for External Quality Assessment include the procedure for organizing this?

Activity

If the laboratory rechecks/retests samples for a certain test (in case no PT or inter-laboratory comparison was possible), does the SOP for External Quality Assessment include the procedure for organizing this?

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