Checklist Assessment


	Has a Baseline Assessment of the laboratory been conducted to gain information on where some elements of a quality management system may be already in place and functioning, or where there are gaps that need to be addressed?	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, controls and, if possible, preventive actions?	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 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
	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
	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 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
	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

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Checklist Assessment

Has a Baseline Assessment of the laboratory been conducted to gain information on where some elements of a quality management system may be already in place and functioning, or where there are gaps that need to be addressed?

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

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?

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, controls and, if possible, preventive actions?

Is the Quality Officer appointed as Internal Auditor?

Have Internal Auditors been appropriately trained and certified?

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

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?

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

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

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?

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

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?

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?

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

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?

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

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

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

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

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

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?

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

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

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

Questions on how it works?

LQSI tool version: 1.0

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Checklist Assessment

Has a Baseline Assessment of the laboratory been conducted to gain information on where some elements of a quality management system may be already in place and functioning, or where there are gaps that need to be addressed?

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

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?

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, controls and, if possible, preventive actions?

Is the Quality Officer appointed as Internal Auditor?

Have Internal Auditors been appropriately trained and certified?

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

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?

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

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

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?

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

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?

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?

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

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?

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

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

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

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

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

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?

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

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

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

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Questions on how it works?

LQSI tool version: 1.0