A Quality Management System that incorporates Quality System Essentials (QSEs) enables your laboratory to:

1.        Contribute to improving patient outcomes
2.        Contribute to saving lives by reducing errors
3.        Decrease potential malpractice risk and exposure through error reduction
4.        Reduce cost by

       Improving operating efficiency

       Reducing the expense of dealing with errors and repeat testing

1.        Meet current and future regulatory and accreditation quality requirements
2.        Participate in pharmaceutical and clinical trials
3.        Improve the health of the patients we serve

Without the right equipment that is accurate and reliable, your laboratory cannot provide test results that contribute meaningfully to patient care.

This Quality System Essential (QSE) is about taking the time to properly select the right equipment; install the equipment and validate its function; maintain and calibrate the equipment according to established requirements; solve and document equipment-related problems; and maintain all required records.

Equipment includes all analyzers, measuring equipment and heat regulating devices.

This section of your Quality Manual should include selection, installation, validation, maintenance, calibration, solve and documentation of equipment problems and maintenance records.

Selection:  Energy requirments, the environment and future disposal must all be considered.

Prior to purchasing the following items need to be considered

• Load bearing capacity
• Space requiremtns
• Electrical requirements
• Ventilation and air quality
• Humidity
• Temperature
• Water Type and quality
• Potential hazards
• Other Manufacturers requirements

Each piece of equipment must be identified by serial number and if a larger organization a lab defined number.