Checklist Phase 2 - Equipment


	Does the laboratory have a standardized, documented procedure for procurement and reception of new equipment?	Activity
	Does the laboratory have a standardized, documented procedure for acceptance or rejection of donated equipment?	Activity
	Is the SOP for Procurement and Reception of Equipment stored at a logical location, accessible to all staff members?	Activity
	Is the SOP for Procurement and Reception of Equipment demonstrably reviewed and verified by fellow staff members?	Activity
	Is the SOP for Procurement and Reception of Equipment demonstrably authorized by laboratory management?	Activity
	Are all technical and managerial staff members aware of the existence of the SOP and do they know when to use it?	Activity
	Has all equipment in the laboratory been labeled?	Activity
	Do the equipment labels include the following data: Equipment code Date of last service/calibration Date of next service/calibration	Activity
	Are the equipment labels resistant to fluids, chemicals, light, and other daily factors causing wear and tear of the labels?	Activity
	Is it documented who is responsible for each piece of equipment and who is authorized to use the equipment?	Activity
	Do staff members who are responsible for a piece of equipment know their responsibilities? Take a sample by asking such a staff member.	Activity
	Are staff members authorized for use of a piece of equipment properly instructed/trained?	Activity
	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?	Activity
	Does the laboratory use log sheets to record usage of specific pieces of equipment where necessary?	Activity
	Do staff members know how and when to fill out Usage Log Sheets/log books for each piece of equipment?	Activity
	Are the Usage Log Sheets placed near the piece of equipment they have been developed for?	Activity
	Are Maintenance Log Sheets of equipment stored orderly in the Equipment Archive?	Activity
	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?	Activity
	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	Activity
	Are Bench Aids used for various pieces of equipment?	Activity
	Are these Bench Aids in accordance with the SOPs for equipment?	Activity
	Is the method of maintenance and calibration of equipment documented?	Activity
	Is the budget needed for the maintenance and calibration of equipment calculated and documented?	Activity
	Have funds been identified for annual maintenance and calibration of equipment?	Activity
	Have funds been identified for training of a staff member for internal maintenance and calibration of equipment?	Activity
	Is a preventive maintenance program in place for all pieces of equipment?	Activity
	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.	Activity
	Is the procedure for ensuring equipment maintenance standardized in an SOP?	Activity
	Does the laboratory have an SOP for Equipment Repair, including a clear procedure for disinfection and clear labeling the equipment as “defect”?	Activity
	Does the laboratory have an SOP explaining the procedure to be followed for ensuring validation of adequate functioning of equipment when it is returned into service after repair?	Activity

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Checklist Phase 2 - Equipment

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

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

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

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

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

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

Has all equipment in the laboratory been labeled?

Do the equipment labels include the following data:

Equipment code

Date of last service/calibration

Date of next service/calibration

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

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

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

Take a sample by asking such a staff member.

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

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?

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

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

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

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

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?

Are Bench Aids used for various pieces of equipment?

Are these Bench Aids in accordance with the SOPs for equipment?

Is the method of maintenance and calibration of equipment documented?

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

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

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

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

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.

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

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

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

Questions on how it works?

LQSI tool version: 1.0

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Checklist Phase 2 - Equipment

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

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

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

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

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

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

Has all equipment in the laboratory been labeled?

Do the equipment labels include the following data: Equipment code Date of last service/calibration Date of next service/calibration

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

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

Do staff members who are responsible for a piece of equipment know their responsibilities? Take a sample by asking such a staff member.

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

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?

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

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

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

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

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?

Are Bench Aids used for various pieces of equipment?

Are these Bench Aids in accordance with the SOPs for equipment?

Is the method of maintenance and calibration of equipment documented?

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

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

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

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

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.

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

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

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

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Questions on how it works?

LQSI tool version: 1.0

Do the equipment labels include the following data:

Equipment code

Date of last service/calibration

Date of next service/calibration

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

Take a sample by asking such a staff member.

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.