Checklist Organization

Is the implementation of the quality management system coordinated through a Quality Project Team?

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Does the laboratory have a Quality Focal Point to which staff can turn to for information about the quality management system?

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Are Quality Project Team meetings held on a regular basis?

The presence of minutes serve as prove for this.

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Is the Quality Project Team functioning correctly?

Look into the minutes to find indications of the quality of functioning of the team; look at the action points, if these are often not completed on/before their deadline this is a sign that the team has trouble implementing activities. In this case, try to find out via signs in the minutes and interviewing team members what the cause of the problem is.

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Has a Quality Officer been appointed?

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Is the position of Quality Officer visible, at the right place, in the Organizational Chart?

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Does the laboratory have a job description of the position of Quality Officer?

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Is the position of Quality Officer included in the Authorization Matrix?

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Do the Quality Officer and Laboratory Manager have regular bilateral meetings to discuss proceedings?

Ask the Quality Officer.

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If a staff member was appointed as Quality Officer, has his former position been filled by a new/another staff member if necessary?

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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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Is the SOP on performing a management review up-to-date?

Compare elements in the Management Review Report with required elements defined in the SOP.

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Does the laboratory make use of action plans with SMART formulated action points?

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Are action plans all stored together in one folder, with a logical structure (e.g. completed action plans in the back, open action plans in the front, sorted on date, etc.)?

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Is the completion of action points and action plans checked on a monthly basis and, if necessary, followed-up?

I.e. do you see action points that have not been completed while their deadline has passed?

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Implementing a quality management system is a process of change. By reacting correctly to critical remarks and resistance towards implementing the quality management system the Laboratory Manager can prevent that staff stops cooperating. This is called change management. Change management is necessary to keep all the staff as possible involved in this process.

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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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p>Are staff meetings held regularly (weekly)?

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Are minutes made of weekly staff meetings?

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Do the minutes of weekly staff meetings include a summary of discussions, SMART action points and the agenda for next week?

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Are the minutes of weekly staff meetings stored in a well-organized way?

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Does the laboratory have an up-to-date routine work schedule?

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Is this Daily Routine Work Schedule placed at a visible location accessible to all staff?

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Do all staff members know where to find the Daily Routine Work Schedule?

Take a sample by asking this question to several staff members.

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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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Has a Biosafety Officer been appointed?

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Is there a description of the tasks and responsibilities of the Biosafety Officer?

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Do all the staff members know who the Biosafety Officer is?

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Do all the staff members know the function of the Biosafety Officer?

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Is the laboratory legally identifiable?

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Is the laboratory and its status recognized by the appropriate authorities?

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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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Has an Equipment Officer been appointed?

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Is the Equipment Officer trained in calibration and technical maintenance of equipment (if necessary)?

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Is the Equipment Officer protected against overburdening of work by allocating tasks of his/her former work to other staff members (if necessary)?

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Are the Organizational Charts up-to-date?

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Are the Organizational Charts signed and dated by the appropriate management?

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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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Does the laboratory have a designated person who is responsible for monitoring stocks and ordering supplies and reagents (called a “Stock Officer”)?

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Are all laboratory staff members aware of the existence of the position of Stock Officer?

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Do all laboratory staff members know who the Stock Officer is?

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Do all laboratory staff members know what the tasks of the Stock Officer are?

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

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If the laboratory is part of a bigger organization: does the laboratory have an Organizational Chart that clearly shows the position of the laboratory within the total organization?

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Is the Organizational Chart that shows the position of the laboratory in the total organization signed and dated by the management of the total organization?

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Does the laboratory have an Organizational Chart showing the organization of all positions within the laboratory?

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Is the chart showing the organization of positions within the laboratory signed and dated by the Laboratory Manager?

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Are the Organizational Charts stored in a folder that is accessible to all the staff members of the laboratory?

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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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