Checklist Phase 3 - Organization


	Does the laboratory have a clear Vision?	Activity
	Is the Vision of the laboratory documented and stored?	Activity
	Does the laboratory have a clear Mission?	Activity
	Is the Mission of the laboratory documented and stored?	Activity
	Does the laboratory have long-term goals?	Activity
	Are the long-term goals of the laboratory covering all the core-activities?	Activity
	Are the long-term goals of the laboratory aimed at improvement?	Activity
	Are the long-term goals of the laboratory documented and stored?	Activity
	Does the laboratory have a Quality Policy?	Activity
	Does the Quality Policy describe clearly the scope of the laboratory services?	Activity
	Does the Quality Policy describe clearly the Long Term Goals and what the laboratory will do to achieve these goals?	Activity
	Does the Quality Policy contain a statement of the management’s commitment to implement and maintain the quality management system?	Activity
	Does the Quality Policy contain a statement of the laboratory's commitment to provide good professional practice, quality examinations, in compliance with the quality management system adhering to ISO 15189?	Activity
	Does the Quality Policy contain a requirement that all staff members of the laboratory must be familiar with the policies and procedures of the laboratory and implement these?	Activity
	Are staff aware of existence of the Quality Policy? Take a sample by randomly asking staff members.	Activity
	Are staff familiar with the contents of the Quality Policy? Take a sample by randomly asking staff members.	Activity
	Have all staff members read the Quality Policy? Request proof such as the Read & Understand List and interview staff members about the contents of the quality policy.	Activity
	Does the laboratory have measures to prevent interruption of services due to break down of old equipment?	Activity
	Is purchasing of new equipment taken into account in making the laboratory budget for the next year?	Activity
	Are maintenance costs (including repairs) taken into account in the laboratory budget?	Activity
	Did the laboratory formulate goals for the coming year prior to drafting the Quality Year Plan?	Activity
	Does the laboratory plan its activities through a Quality Year Plan?	Activity
	Is the Quality Year Plan complete (does it cover all the aspects of the quality management system)?	Activity
	Has the Quality Year Plan been formulated with input from the Quality Officer? Take a sample by asking the Quality Officer and some members of the Quality Project Team.	Activity
	Is the Quality Year Plan appropriately stored and easily retrievable?	Activity
	Is the Quality Year Plan signed and dated by management?	Activity
	Is the Quality Year Plan translated into an action plan?	Activity
	Is this action plan of the Quality Year Plan signed and dated by the Laboratory Manager for approval?	Activity
	Is staff aware of the existence of the Quality Year Plan? Take a sample by asking some random staff member to explain what the Quality Year Plan is.	Activity
	Are staff members aware of action points assigned to them? Take a sample by asking staff members about action points assigned to them.	Activity
	Is the quality management system appropriately documented in a quality manual, i.e. does it include information on each of the 12 quality system essentials and how these are implemented in the laboratory?	Activity
	Is the quality manual part of the document control system?	Activity
	Have all staff members read the quality manual?	Activity
	Is the performance of the quality management system recorded in Quarterly Reports?	Activity
	Is the functioning of the quality management system reviewed annually by laboratory management?	Activity
	Are reports drafted of management reviews?	Activity
	Do Management Review Reports include action points if applicable?	Activity
	Are the result of the management review presented to all staff? See meeting minutes.	Activity
	Are Management Review Reports securely and orderly stored?	Activity
	Does the Quality Year Plan include action points from the management review?	Activity
	Does the Quality Year Plan take into account the Quality Policy, Long Term Goals, Core Values, Mission and Vision of the laboratory?	Activity
	Is an action plan drafted based on the action points yielding from the Quality Year Plan?	Activity
	Has the Quality Year Plan and the action plan based on the Quality Year Plan been presented to the laboratory staff? See minutes of that meeting.	Activity
	Have all the policy cycle activities been documented in an SOP (i.e. drafting a quality year plan, monitoring of performance of the quality management system and drafting quarterly reports, and performing a management review)?	Activity

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Checklist Phase 3 - Organization

Does the laboratory have a clear Vision?

Is the Vision of the laboratory documented and stored?

Does the laboratory have a clear Mission?

Is the Mission of the laboratory documented and stored?

Does the laboratory have long-term goals?

Are the long-term goals of the laboratory covering all the core-activities?

Are the long-term goals of the laboratory aimed at improvement?

Are the long-term goals of the laboratory documented and stored?

Does the laboratory have a Quality Policy?

Does the Quality Policy describe clearly the scope of the laboratory services?

Does the Quality Policy describe clearly the Long Term Goals and what the laboratory will do to achieve these goals?

Does the Quality Policy contain a statement of the management’s commitment to implement and maintain the quality management system?

Does the Quality Policy contain a statement of the laboratory's commitment to provide good professional practice, quality examinations, in compliance with the quality management system adhering to ISO 15189?

Does the Quality Policy contain a requirement that all staff members of the laboratory must be familiar with the policies and procedures of the laboratory and implement these?

Are staff aware of existence of the Quality Policy? Take a sample by randomly asking staff members.

Are staff familiar with the contents of the Quality Policy? Take a sample by randomly asking staff members.

Have all staff members read the Quality Policy? Request proof such as the Read & Understand List and interview staff members about the contents of the quality policy.

Does the laboratory have measures to prevent interruption of services due to break down of old equipment?

Is purchasing of new equipment taken into account in making the laboratory budget for the next year?

Are maintenance costs (including repairs) taken into account in the laboratory budget?

Did the laboratory formulate goals for the coming year prior to drafting the Quality Year Plan?

Does the laboratory plan its activities through a Quality Year Plan?

Is the Quality Year Plan complete (does it cover all the aspects of the quality management system)?

Has the Quality Year Plan been formulated with input from the Quality Officer? Take a sample by asking the Quality Officer and some members of the Quality Project Team.

Is the Quality Year Plan appropriately stored and easily retrievable?

Is the Quality Year Plan signed and dated by management?

Is the Quality Year Plan translated into an action plan?

Is this action plan of the Quality Year Plan signed and dated by the Laboratory Manager for approval?

Is staff aware of the existence of the Quality Year Plan? Take a sample by asking some random staff member to explain what the Quality Year Plan is.

Are staff members aware of action points assigned to them? Take a sample by asking staff members about action points assigned to them.

Is the quality management system appropriately documented in a quality manual, i.e. does it include information on each of the 12 quality system essentials and how these are implemented in the laboratory?

Is the quality manual part of the document control system?

Have all staff members read the quality manual?

Is the performance of the quality management system recorded in Quarterly Reports?

Is the functioning of the quality management system reviewed annually by laboratory management?

Are reports drafted of management reviews?

Do Management Review Reports include action points if applicable?

Are the result of the management review presented to all staff? See meeting minutes.

Are Management Review Reports securely and orderly stored?

Does the Quality Year Plan include action points from the management review?

Does the Quality Year Plan take into account the Quality Policy, Long Term Goals, Core Values, Mission and Vision of the laboratory?

Is an action plan drafted based on the action points yielding from the Quality Year Plan?

Has the Quality Year Plan and the action plan based on the Quality Year Plan been presented to the laboratory staff? See minutes of that meeting.

Have all the policy cycle activities been documented in an SOP (i.e. drafting a quality year plan, monitoring of performance of the quality management system and drafting quarterly reports, and performing a management review)?

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Questions on how it works?

LQSI tool version: 1.0

Are staff aware of existence of the Quality Policy?

Take a sample by randomly asking staff members.

Are staff familiar with the contents of the Quality Policy?

Take a sample by randomly asking staff members.

Have all staff members read the Quality Policy?

Request proof such as the Read & Understand List and interview staff members about the contents of the quality policy.

Has the Quality Year Plan been formulated with input from the Quality Officer?

Take a sample by asking the Quality Officer and some members of the Quality Project Team.

Is staff aware of the existence of the Quality Year Plan?

Take a sample by asking some random staff member to explain what the Quality Year Plan is.

Are staff members aware of action points assigned to them?

Take a sample by asking staff members about action points assigned to them.

Are the result of the management review presented to all staff?

See meeting minutes.

Has the Quality Year Plan and the action plan based on the Quality Year Plan been presented to the laboratory staff?

See minutes of that meeting.