Checklist Phase 2 - Equipment

Does the laboratory have a standardized, documented procedure for procurement and reception of new equipment?

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Does the laboratory have a standardized, documented procedure for acceptance or rejection of donated equipment?

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Is the SOP for Procurement and Reception of Equipment stored at a logical location, accessible to all staff members?

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Is the SOP for Procurement and Reception of Equipment demonstrably reviewed and verified by fellow staff members?

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Is the SOP for Procurement and Reception of Equipment demonstrably authorized by laboratory management?

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Are all technical and managerial staff members aware of the existence of the SOP for Procurement and Reception of Equipment and do they know when to use it?

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Has all equipment in the laboratory been labeled?

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Do the equipment labels include the following data:

  • Equipment code
  • Date of last service/calibration
  • Date of next service/calibration

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Are the equipment labels resistant to fluids, chemicals, light, and other daily factors causing wear and tear of the labels?

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Is it documented who is responsible for each piece of equipment and who is authorized to use the equipment?

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Do staff members who are responsible for a piece of equipment know their responsibilities?

Take a sample by asking such a staff member.

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Are staff members authorized for use of a piece of equipment properly instructed/trained?

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Does the laboratory have a Maintenance Log Sheet for each piece of equipment that shows what maintenance has been performed at which moment to which piece of equipment?

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Does the laboratory use log sheets to record usage of specific pieces of equipment where necessary?

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Do staff members know how and when to fill out Usage Log Sheets/log books for each piece of equipment?

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Are the Usage Log Sheets placed near the piece of equipment they have been developed for?

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Are Maintenance Log Sheets of equipment stored orderly in the Equipment Archive?

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Does the laboratory have an Equipment Archive that contains all the documents and records needed for each piece of equipment as listed in ISO 15189:2007 article 5.3.4 or ISO 15189:2012 article 5.3.1.7?

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Does the laboratory have a documented procedure that describes the following:

  • Activities that need to be undertaken when new equipment is introduced in the laboratory
  • The required measures for ensuring maintenance and calibration of the piece of equipment
  • Ensuring presence of the SOP for maintenance and use of the piece of equipment

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Are Bench Aids used for various pieces of equipment?

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Are these Bench Aids in accordance with the currently authorized versions of SOPs for equipment?

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Is the method of maintenance and calibration of equipment documented?

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Is the budget needed for the maintenance and calibration of equipment calculated and documented?

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Have funds been identified for annual maintenance and calibration of equipment?

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Have funds been identified for training of a staff member for internal maintenance and calibration of equipment?

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Is a preventive maintenance program in place for all pieces of equipment?

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Does the laboratory demonstrably adhere to this program?

Compare maintenance records for a piece of equipment from the equipment file with the dates this maintenance was planned in the Equipment Maintenance Schedule.

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Is the procedure for ensuring equipment maintenance standardized in an SOP?

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Does the laboratory have an SOP for Equipment Repair, including a clear procedure for disinfection and clear labeling the equipment as “defect”?

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Does the laboratory have an SOP explaining the procedure to be followed for ensuring validation of equipment when it is returned into service after repair?

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