Laboratory equipment management is the process of controlling equipment throughout its lifecycle, from needs assessment, acceptance, installation, and verification of operational capability to calibration, maintenance, repair, and decommissioning. The objective is not simply to keep equipment running, but to ensure that it remains suitable for the testing method, generates controllable data, and is consistently available for use.
Even a well-configured analyzer can create operational risks if it has not been verified before use, lacks a calibration schedule, has uncontrolled software versions, or has no defined response when quality control results are abnormal. Laboratories therefore need to manage equipment, reagents, control materials, technical documentation, data, and operator competency together.
An effective process should allow the facility to clearly answer: Where is the equipment located? Who is responsible for it? What is its current status? Which activities are approaching their due dates? And is the equipment still suitable for its intended use?
Core Principles to Standardize
- Each device should have a unique identification code and a lifecycle record.
- Equipment should enter routine use only after acceptance, installation, training, and verification against laboratory-defined criteria have been completed.
- Maintenance, calibration, functional checks, and quality control are related activities, but they do not fully replace one another.
- Management frequencies should be based on manufacturer instructions, utilization level, risk, and equipment history.
- When equipment fails to meet requirements, the laboratory must control both the equipment and any results that may have been affected.
- Management data are useful only when they are updated promptly after maintenance, repair, configuration changes, or equipment relocation.
Laboratory Equipment Should Be Managed as Part of the Testing Process
In many facilities, laboratory equipment is managed mainly as an asset: purchase date, acquisition cost, location, and user department. This information is necessary, but it does not fully reflect the role of equipment within the testing system.
A laboratory device may affect:
- Specimen preparation.
- Specimen identification.
- Required sample volume.
- Turnaround time.
- Process stability.
- Alert detection.
- Data transmission to the LIS.
- Internal quality control.
- Historical traceability.
- Emergency sample handling.
- Reagent and consumable costs.
- Service continuity when equipment is unavailable.
WHO considers equipment management an essential component of a laboratory quality management system. The program should cover equipment selection, installation, training, maintenance, calibration, troubleshooting, repair, and recordkeeping.
Equipment should therefore not be evaluated separately from:
- Testing methods.
- Reagents.
- Calibrators.
- Control materials.
- Software.
- Electrical, water, and environmental infrastructure.
- Information systems.
- Operating personnel.
- Backup arrangements.
Managing each device well without controlling these interdependencies can still result in an unstable overall testing process.
The Laboratory Equipment Management Lifecycle
Instead of creating multiple disconnected forms, laboratories can build a management system around six continuous stages.
| Stage | Management Objective |
|---|---|
| Before acceptance | Confirm that the equipment is appropriate for the need, method, and infrastructure |
| Acceptance and installation | Confirm that the correct equipment and full configuration have been delivered under appropriate technical conditions |
| Pre-use verification | Demonstrate that the equipment operates appropriately for the laboratory's intended purpose |
| Routine operation | Maintain operating conditions, monitor status, and control quality |
| Maintenance and calibration | Maintain function, reliability, and technical traceability |
| Repair and decommissioning | Control faulty equipment, assess impact, and determine the appropriate course of action |
Each stage should generate records that provide the basis for the next stage.
Stage 1: Management Should Begin Before the Equipment Is Delivered
Equipment should be selected only after the laboratory has clearly defined its intended use.
Questions to answer before purchasing, leasing, or accepting equipment include:
- Which testing method will the equipment support?
- What is the expected test menu?
- What are average and peak sample volumes?
- Are emergency samples expected?
- What specimen types and sample volumes are involved?
- What turnaround time is required?
- What is the contingency plan if the equipment becomes unavailable?
- Does the device need LIS connectivity?
- How will reagents and consumables be supplied?
- What are the electrical, water, temperature, and humidity requirements?
- Can current staff operate the system?
- What are the expected calibration, maintenance, and spare part costs?
The decision should not be based only on nominal throughput. A high-throughput system may not deliver corresponding value if it requires lengthy maintenance, uses large reagent pack sizes, or does not fit the actual specimen workflow.
Documentation to Collect Before Acceptance
Depending on the equipment, the laboratory should request:
- Catalog and technical documentation.
- Instructions for use.
- Installation instructions.
- Electrical, water, and environmental requirements.
- Configuration list.
- Accessory list.
- Reagent menu.
- Calibrator information.
- Quality control material information.
- Maintenance plan.
- Calibration recommendations.
- LIS connectivity documentation.
- Warranty scope.
- Warranty service provider information.
- Spare parts list.
- Training plan.
- Market authorization and product identification documentation.
Medical devices in Vietnam should be managed in accordance with current regulations. As of August 2026, Consolidated Document No. 08/VBHN-BYT dated March 6, 2026, consolidates regulations on medical device management.
Stage 2: Equipment Acceptance Is More Than Checking Quantity
When equipment arrives at the laboratory, acceptance should involve the medical equipment department, laboratory, supplier, and other relevant units.
Verify Identification Information
The following information should match across the contract, documentation, and actual equipment:
- Device name.
- Model.
- Serial number.
- Manufacturer.
- Manufacturing facility.
- Year of manufacture, where available.
- Software version.
- Module list.
- Accessory list.
- Initial consumables.
Each device should be assigned a unique management code. The device name or installation location alone should not be used as the identifier because equipment may later be relocated.
Check Condition at Handover
The laboratory should document:
- Packaging condition.
- External condition of the equipment.
- Signs of impact or damage.
- Power cables and connectors.
- Accessory quantity.
- Included consumables.
- Technical documentation.
- Seal condition.
- Transport conditions where relevant.
- Acceptance date and personnel involved.
If abnormalities are identified, they should be documented before installation proceeds.
Confirm Infrastructure Before Powering On
Equipment should not be connected and test-run until the required input conditions have been confirmed.
Depending on the system, checks may include:
- Power supply.
- Grounding.
- UPS.
- Backup power.
- Input water.
- Wastewater system.
- Temperature.
- Humidity.
- Ventilation.
- Bench or floor load capacity.
- Maintenance clearance.
- Network infrastructure.
- Connection ports.
- Reagent storage location.
- Specimen handling area.
The supplier may conduct an installation site assessment, but the laboratory should still retain the results and confirm facility conditions.
Stage 3: Verify Equipment Before Routine Use
Correct installation does not automatically mean that the system is suitable for the laboratory's testing process.
Before the equipment is used for patient specimens, the laboratory should verify it according to an approved plan. The scope may vary depending on the method, complexity, and intended use.
Typical areas for review include:
- Correct installation of the agreed configuration.
- Activation of required software and modules.
- Basic functions operate correctly.
- Alerts are displayed appropriately.
- Specimen identification functions correctly.
- Information is transmitted correctly to the LIS.
- Reagents are recognized.
- Calibrators and control materials are compatible.
- Test results meet laboratory-defined criteria.
- Staff have completed training.
ISO 15189:2022 establishes requirements for quality and competence in medical laboratories, including equipment management, calibration, and metrological traceability. Application should be appropriate to the scope of each laboratory.
Establish Baseline Data for Each Device
When equipment first enters use, baseline records should include:
- Installation date.
- Start-of-operation date.
- Initial software version.
- Initial configuration.
- Initial verification results.
- Calibration information.
- Quality control information.
- Trained personnel.
- First maintenance schedule.
- User account list.
- Primary person responsible.
These baseline data provide a reference if equipment performance changes over time.
Stage 4: Management During Routine Operation
Once the equipment enters routine use, responsibilities are shared among operators, equipment coordinators, quality personnel, and technical teams.
Start-of-Shift or Pre-Use Checks
Depending on the device, operators may need to check:
- Power supply.
- System temperature.
- Water or solution levels.
- Reagents.
- Waste.
- Consumables.
- Probe or aspiration needle condition.
- Software notifications.
- LIS connection.
- Maintenance schedule.
- Calibration status.
- Quality control results.
The checklist should be short, clear, and appropriate for the device. If it is overly long or duplicates checks already performed automatically by the system, users may complete it only as a formality.
What Should an Operating Log Capture?
Not every action needs to be recorded manually. However, the laboratory should be able to trace:
- Who operated the device.
- When it was used.
- Which alerts occurred.
- Relevant reagent and consumable lots.
- Most recent calibration.
- Quality control results.
- Incidents that occurred.
- Corrective actions taken.
- Equipment downtime.
- When the device returned to service.
These data may be stored in device software, the LIS, electronic logs, or paper records. What matters is that the laboratory knows where the information is stored and can retrieve it when necessary.
User and Account Management
For software-based equipment, permissions should be assigned by role:
- Operator.
- Result validator.
- Reagent manager.
- Maintenance technician.
- Administrator.
- Supplier personnel.
A shared administrator account should not be used by all staff. Default accounts and passwords provided by the supplier should be appropriately controlled.
Stage 5: Distinguishing Calibration, Checks, and Maintenance
These activities may occur around the same time but serve different purposes.
| Activity | Question It Answers |
|---|---|
| Functional check | Can the equipment perform the intended function? |
| Calibration | How is the relationship between the equipment signal and the reference value established? |
| Intermediate check | Does the equipment remain in an acceptable state between formal evaluations? |
| Preventive maintenance | What work is required to reduce failures and maintain operation? |
| Repair | What fault needs to be corrected? |
| Post-repair verification | Can the equipment safely return to use? |
A maintenance record should not be used in place of calibration documentation when calibration is required for the equipment or method. Likewise, a recently calibrated device does not mean that its mechanical components, power system, or sample aspiration system have been maintained.
Calibration Should Be Planned
The laboratory should define:
- Which equipment or components require calibration.
- Calibration method.
- Standards or materials used.
- Person performing the work.
- Frequency.
- Acceptance criteria.
- Actions if results are unacceptable.
- Records to retain.
- Circumstances requiring recalibration.
WHO recommends that equipment SOPs include calibration procedures when routine calibration is required. WHO also advises laboratories to define maintenance and calibration methods for each device based on equipment complexity and available capability.
Calibration or reassessment may be required:
- At the scheduled interval.
- After repair.
- After replacement of a critical component.
- After adjustment.
- After an update affecting measurement.
- When quality control becomes unstable.
- After equipment relocation.
- When there are signs of deviation.
- As required by the manufacturer or method.
Not every situation automatically requires the same procedure. The laboratory should assess the impact and document the decision.
Build a Maintenance Program Instead of Waiting for Equipment Failure
Preventive maintenance allows the laboratory to plan downtime, materials, and personnel before unplanned failure occurs.
WHO recommends establishing maintenance and calibration programs for all equipment, developing annual schedules, and allocating sufficient resources to complete activities as planned.
A Maintenance Plan Should Include Three Levels
Tasks performed by operators
- Daily cleaning.
- Checking solution levels.
- Waste handling.
- Routine consumable replacement.
- Reviewing alerts.
- Performing shutdown procedures.
- Proper accessory storage.
Tasks performed by internal technical personnel
- Functional checks.
- Checking cables and connectors.
- Replacing permitted components.
- Backing up configurations.
- Reviewing fault history.
- Coordinating environmental checks.
- Supervising supplier service work.
Tasks performed by the supplier or external service provider
- Advanced maintenance.
- Replacement of critical components.
- Service-level software intervention.
- System adjustment.
- Specialized testing.
- Complex troubleshooting.
This division helps avoid two problems: complete dependence on the supplier and internal personnel working beyond their authorized scope.
Do Not Apply the Same Maintenance Interval to Every Device
Maintenance frequency should be based on:
- Manufacturer instructions.
- Utilization level.
- Operating hours.
- Number of cycles.
- Environmental conditions.
- Failure history.
- Criticality.
- Availability of backup equipment.
- Method requirements.
- Technical capability.
Two devices of the same model may require different levels of monitoring if their sample volumes are significantly different.
Managing Equipment When an Incident Occurs
When equipment behaves abnormally, the first priority is not immediate repair but control of its use status.
The laboratory should:
1. Stop use where there is a risk of affecting results.
2. Label the equipment or change its status in the management system.
3. Notify the responsible person.
4. Record the time and observed issue.
5. Preserve specimens where repeat analysis may be possible.
6. Activate the backup plan.
7. Determine which results may have been affected.
8. Coordinate inspection or repair.
9. Verify the device before returning it to use.
10. Retain all related records.
Do Not Only Repair the Device—Assess Results Already Generated
If equipment deviation is detected, the laboratory should review:
- When did the deviation begin?
- What was the most recent acceptable quality control result?
- Which specimens were analyzed during the affected period?
- Are any results abnormal or questionable?
- Is repeat testing required?
- Should the result user be notified?
- Is corrective or preventive action required?
This is an important distinction between general equipment management and laboratory equipment management. A failure may affect not only the asset but also data already generated.
Circular No. 01/2013/TT-BYT requires healthcare facilities with laboratories to establish quality management plans, standard operating procedures, and systems for monitoring, identifying, and addressing errors or risks of error. Circular No. 25/2026/TT-BYT was issued on June 30, 2026, to amend certain related provisions and took effect on August 15, 2026. Facilities should consider this effective date when updating procedures.
Conditions for Returning Equipment to Service
After major maintenance or repair, equipment should not be returned to the laboratory based only on a statement that the fault has been corrected.
Depending on the scope of intervention, the laboratory should confirm:
- The original fault no longer occurs.
- Related functions operate correctly.
- Verification results meet acceptance criteria.
- Recalibration has been completed where necessary.
- Quality control is acceptable.
- Data connectivity functions correctly.
- Software is at the correct version.
- Accounts and configurations have not changed outside the approved plan.
- Repair records are complete.
- The laboratory has formally accepted the device back into service.
If the equipment has not fully met all requirements but is allowed to operate under restrictions, the restrictions should be clearly documented and communicated to users.
Managing Software and LIS Connectivity
Many laboratory devices now depend on software for:
- Specimen management.
- Result calculation.
- Reagent identification.
- Calibration tracking.
- Quality control data storage.
- Result transmission.
- User management.
- Fault diagnostics.
- Remote support.
Software versions should therefore be managed as part of the equipment configuration.
Each update should document:
- Previous and new versions.
- Reason for the update.
- Person performing the update.
- Date performed.
- Expected impact.
- Data backup status.
- Functions checked after the update.
- LIS connectivity results.
- Any issues identified.
Suppliers should not update software or change configurations without appropriate notification and confirmation from the facility.
When the LIS Is Unavailable
The laboratory should have procedures for:
- Receiving test requests.
- Creating specimen IDs.
- Operating equipment in standalone mode.
- Temporarily storing results.
- Controlling manual data entry.
- Synchronizing data after system recovery.
- Preventing duplicate reporting.
- Tracing the person performing each action.
The ability to operate during connectivity loss should be tested in advance rather than developed only after an incident occurs.
Management Records Should Follow Each Device
A laboratory equipment file should include the following record groups:
| Record Group | Content |
|---|---|
| Identification | Name, model, serial number, equipment ID, location |
| Acceptance | Delivery, configuration, accessories, initial condition |
| Installation | Infrastructure conditions, installation record, software version |
| Verification | Plan, criteria, data, and pre-use results |
| Training | Content, trainer, personnel list |
| Operation | SOPs, logs, alerts, and status |
| Calibration | Method, results, date performed, and next due date |
| Maintenance | Schedule, work performed, spare parts, and recommendations |
| Repair | Fault, cause, corrective action, and post-repair results |
| Software | Versions, updates, configuration, and licensing |
| Incidents | Impact assessment, corrective actions, and related results |
| Relocation | Previous location, new location, and post-move assessment |
| Decommissioning | Reason, approval, data handling, and asset disposition |
Records may be maintained electronically or through a combination of electronic and paper systems. The key requirements are traceability, access control, and backup capability.
Assign Responsibilities So the Process Does Not Break Down
Laboratory Manager
- Approve or propose the equipment management plan.
- Set priorities.
- Allocate resources.
- Oversee implementation.
- Decide or recommend when equipment should be withdrawn from use.
- Coordinate assessment of the impact on laboratory results.
Equipment Coordinator
WHO recommends appointing a person with an overall view of laboratory equipment management to coordinate related activities. This person may monitor maintenance and calibration schedules, records, and coordination with technical service providers.
Responsibilities may include:
- Managing the equipment inventory.
- Updating status.
- Monitoring schedules.
- Reviewing records.
- Coordinating maintenance.
- Tracking incidents.
- Managing documentation.
- Compiling indicators.
Operators
- Follow SOPs.
- Perform pre-use checks.
- Record alerts.
- Avoid unauthorized intervention.
- Report faults promptly.
- Care for equipment properly.
- Perform user-level maintenance tasks.
Medical Equipment or Technical Department
- Support infrastructure assessment.
- Manage technical information.
- Coordinate with suppliers.
- Review repairs.
- Monitor spare parts.
- Manage maintenance contracts.
- Support relocation and disposal.
Information Technology Department
- Manage connectivity.
- Control network permissions.
- Manage backups.
- Support security.
- Monitor servers and the LIS.
- Coordinate software updates.
Indicators That Reflect Equipment Management Quality
Laboratories may select indicators such as:
- Percentage of equipment with complete records.
- Percentage of maintenance activities completed on time.
- Percentage of calibrations completed on schedule.
- Number of overdue devices.
- Number of unplanned shutdowns.
- Total downtime.
- Incident response time.
- Repeated fault rate.
- Repair costs.
- Number of results affected by equipment incidents.
- Percentage of staff trained.
- Number of software updates.
- Percentage of devices with stable LIS connectivity.
- Number of cases in which specimens had to be referred to another facility.
Indicators should not be compiled only for reporting. When negative trends appear, the facility should investigate causes and implement improvement actions.
When Should Equipment Replacement Be Considered?
Equipment may still power on while no longer being appropriate for continued use.
Indicators that replacement should be considered include:
- Repeated failures.
- Increasing downtime.
- High repair costs.
- Manufacturer support has ended.
- Spare parts are no longer available.
- Software is no longer updated.
- The device cannot connect to newer systems.
- Capacity no longer meets demand.
- Reagents are no longer available.
- Quality control performance is difficult to maintain.
- The device no longer supports new methods.
- Operational risks exceed the facility's ability to control them.
Replacement decisions should be based on lifecycle data rather than equipment age alone.
Laboratories should compare options such as:
- Continue using the equipment.
- Major repair.
- Upgrade.
- Replace a module.
- Relocate the equipment.
- Purchase new equipment.
- Lease equipment.
- Transition to another service model.
A Strong Management Process Should Support Predictive Planning
The maturity of an equipment management system is not measured by the number of forms it uses, but by its ability to anticipate work and risk.
A laboratory with effective equipment management should be able to identify in advance:
- Which devices are approaching maintenance deadlines.
- Which reagents may face shortages.
- Which components fail frequently.
- Which devices show increasing downtime.
- Which software versions are approaching end of support.
- Which staff require retraining.
- Which equipment should be replaced in the next investment cycle.
- Which areas lack adequate backup arrangements.
When data are updated continuously, management can shift from incident response to proactive control.
This article is provided for informational purposes only. Laboratories should develop procedures appropriate to their scope of clinical or laboratory practice, testing methods, quality management systems, manufacturer instructions, and current regulations.
Optimizing Laboratory Equipment Lifecycle Management at PHARMEDI & HEALTHCARE VIETNAM 2026
Laboratory equipment creates real value only when it remains in an appropriate operating state throughout its service life. After selection and installation, laboratories must continue to control calibration, maintenance, quality control, software versions, data connectivity, repair history, and spare part availability over the years that follow.
This means that equipment management increasingly extends beyond a maintenance logbook. As the number of devices grows, laboratories adopt more automation, and data become increasingly connected to LIS platforms, facilities need a coordinated approach across equipment – people – data – technical services.
At PHARMEDI & HEALTHCARE VIETNAM 2026, the exhibition ecosystem includes laboratory equipment, medical devices and instruments, and IT solutions and applications for healthcare. The exhibition area is designed to help professional visitors explore new solutions, compare technologies, and identify options aligned with their organization's investment and upgrade plans.
For laboratories, medical equipment departments, and quality management teams, visiting PHARMEDI VIETNAM 2026 also provides an opportunity to discuss in greater depth with suppliers the issues that often become visible only after equipment enters routine operation:
- What preventive maintenance intervals does the manufacturer recommend?
- Which tasks can operators perform themselves, and which require specialized engineers?
- Which devices or components require calibration, periodic checks, or post-repair verification?
- Does the supplier support maintenance schedule tracking, calibration scheduling, and equipment status monitoring?
- Can equipment management software retain fault history, repair records, component replacements, and software versions?
- How does the equipment connect to the LIS, and which data can be exchanged automatically?
- What verification steps are required after software updates or configuration changes?
- How are technical response times and on-site support organized?
- Which spare parts should be kept in reserve, and what are typical component lead times?
- If the primary system becomes unavailable, what support or backup equipment options can the supplier provide?
- Can technical records, maintenance reports, and service data be exported for laboratory storage and traceability?
- How long will the manufacturer and distributor continue supporting the equipment after the warranty period?
These considerations are particularly important for high-use laboratory systems because an equipment incident can affect more than the asset itself. It may interrupt specimen flow, extend turnaround time, and create a need to reassess data already generated.
Discussions at the exhibition do not replace calibration, quality control, maintenance procedures, or laboratory management requirements. Their value lies in helping facilities better understand the support capabilities of different solutions and suppliers before incorporating requirements for technical services, data management, and lifecycle support into investment plans.
In addition to the exhibition area, PHARMEDI VIETNAM 2026 also offers group visit programs for hospitals, medical centers, clinics, and healthcare facilities, creating additional opportunities for organizations with investment needs to engage directly with relevant companies and solutions.
In this way, PHARMEDI & HEALTHCARE VIETNAM 2026 provides laboratories with an opportunity not only to explore new equipment, but also to evaluate the full range of capabilities required to sustain equipment after it enters service — from calibration, maintenance, and spare parts to LIS connectivity, software, and long-term technical support.
Dates: September 22–24, 2026
Venue: Saigon Exhibition and Convention Center (SECC), Ho Chi Minh City
Exhibitor Registration:https://pharmed.vn/exhibitor/application-formVisitor Registration:https://ers-vn.informa-info.com/pha2026?cid=FB
ContactBooth Booking:[email protected] (Thanh Thuý)
Media Support:[email protected] (Anita Pham)
Visitor Support:[email protected] (Ciel Le)