Checklist Phase 3 - Organization

In this phase the management cycle will be implemented. This is a cycle of continuous improvement where the management plans activities, monitors their execution, check if they were done correctly, and based on that, plans for implementing improvement activities for the next year. This facilitates efficient planning and management of the laboratory. However, planning without having a clear goal in mind is impossible. Before implementing the management cycle one has to develop a clear Vision, Mission, long-term goals, and long-term planning, which will result in a Quality Policy.

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Does the laboratory have a clear Mission?

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Is the Mission of the laboratory documented and stored?

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Does the laboratory have long-term goals?

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

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

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

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Does the laboratory have a Quality Policy?

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

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

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

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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?

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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?

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Are staff aware of existence of the Quality Policy?

Take a sample by randomly asking staff members.

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Are staff familiar with the contents of the Quality Policy?

Take a sample by randomly asking staff members.

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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).

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

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

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

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

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

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

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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.

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Is the Quality Year Plan appropriately stored and easily retrievable?

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Is the Quality Year Plan signed and dated by management?

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Is the Quality Year Plan translated into an action plan?

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

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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.

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Are staff members aware of action points assigned to them?

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

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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?

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Is the quality manual part of the document control system?

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Have all staff members read the quality manual?

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

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

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Are reports drafted of management reviews?

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Do Management Review Reports include action points if applicable?

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

See meeting minutes.

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Are Management Review Reports securely and orderly stored?

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After the management review has been completed, is a new quality year plan drafted, (among others) based on the findings from the management review?

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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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