Medical equipment verification and calibration both involve controlling the technical characteristics of equipment, but they serve different purposes and cannot be used interchangeably. Verification generally focuses on assessing whether equipment meets applicable technical or metrological requirements and determining whether it conforms to those requirements. Calibration, by contrast, establishes the relationship between the value indicated by the equipment and a reference value from a measurement standard, helping healthcare facilities identify measurement error and assess the reliability of measurement results.
A device may require verification, calibration, maintenance, or a combination of several activities throughout its lifecycle. The appropriate activities should be determined based on the device's function, manufacturer instructions, intended use, level of risk, and current regulations. Hospitals should therefore avoid relying solely on equipment names or established management practices when creating a single schedule for the entire equipment inventory.
The Core Difference Between Medical Equipment Verification and Calibration
Under Vietnam's Law on Measurement, verification of measuring instruments is the activity of evaluating and confirming the metrological characteristics of a measuring instrument against applicable metrological technical requirements. Calibration is the activity of determining and establishing the relationship between measurement values of a measurement standard and those of a measuring instrument.
At the international level, the BIPM's International Vocabulary of Metrology also clearly distinguishes calibration from verification of conformity. Calibration establishes a relationship between instrument indications and reference values, together with information on measurement uncertainty, while verification provides evidence that an item meets specified requirements.
In simple terms:
Comparison of Medical Equipment Verification and Calibration
| Criterion | Medical Equipment Verification | Medical Equipment Calibration |
|---|---|---|
| Primary objective | Determine whether equipment meets applicable technical, metrological, or regulatory requirements | Establish the relationship between the value indicated by the equipment and the reference value |
| Typical result | Pass, fail, or another assessment result according to applicable requirements | Measurement error, correction factor, measurement uncertainty, or other calibration data |
| Basis for implementation | Regulations, technical regulations, verification procedures, or applicable management requirements | Standards, calibration methods, manufacturer requirements, or quality system requirements |
| Practical significance | Confirms conformity with specified requirements | Provides data for assessing measurement accuracy and reliability |
| Is it the same as repairing equipment? | No | No |
| Does it automatically adjust the equipment? | Not necessarily | No; calibration is not the same as adjustment |
| Documentation output | Certificate, label, report, or verification result depending on the case | Calibration certificate or result, error table, and related data |
| Mandatory for every device? | No | No |
| Can both apply to the same device? | Yes | Yes |
An important point is that a calibration certificate does not automatically demonstrate that the equipment meets all requirements for use. The technical or quality management team still needs to compare the calibration results with the device's acceptable limits and its actual intended use.
Why Are These Two Concepts Often Confused?
Confusion often arises because both verification and calibration may involve measurement standards, technical methods, and documented results. In everyday communication, these activities may also be grouped under general terms such as "equipment checking" or "accuracy checking."
However, using a generic term can create management problems:
To reduce these risks, equipment management plans should separate the following activities into distinct fields:
Each field should include the date performed, service provider, result, supporting documentation, and next due date.
Can a Device Require Both Verification and Calibration?
Yes. Verification and calibration are not mutually exclusive.
A device with a measurement function may be calibrated to determine its measurement error at selected points. The calibration data may then be used to assess whether the equipment meets permissible limits or applicable technical requirements.
In practice, a workflow may include the following steps:
Not every device needs to go through every step. The specific sequence depends on the equipment, technical requirements, manufacturer documentation, and relevant regulations.
Not All Medical Equipment Should Be Managed in the Same Way
Hospitals manage a highly diverse range of medical equipment. Some devices generate direct measurements; some provide treatment, support, or sample-processing functions; and some systems mainly provide images, data, or alerts.
Hospitals should therefore avoid establishing rules such as:
To determine appropriate requirements, healthcare facilities may classify equipment into internal management groups:
| Equipment Group | Issues to Consider |
|---|---|
| Equipment with measurement functions | Accuracy, measurement error, measurement uncertainty, and verification or calibration requirements |
| Equipment with alarm functions | Alarm sensitivity, set thresholds, sound, display, and system response |
| Equipment delivering energy or flow | Output control, safety limits, and stability |
| Laboratory equipment | Result quality, quality control, reagents, system calibration, and maintenance |
| Diagnostic imaging equipment | Image quality, safety, performance, software, and infrastructure conditions |
| Life-support equipment | Availability, safety checks, backup power, and prioritized maintenance schedules |
| Software or connected systems | Version, configuration, data, permissions, integration, and verification after updates |
This table is intended only to support internal management classification. It is not a legal list defining which devices are subject to mandatory verification or calibration.
How to Determine Whether Equipment Requires Verification or Calibration
Rather than relying on assumptions, healthcare facilities can follow the process below.
Step 1: Identify the Function and Intended Use
The facility should clarify:
The same type of equipment may be subject to different management requirements depending on its intended use.
Step 2: Review Manufacturer Instructions
Manufacturer documentation may specify:
If this information is unavailable, the facility should request additional documentation from the supplier before independently developing its own procedure.
Step 3: Review Current Legal Requirements
Healthcare facilities should determine:
As of August 2026, Consolidated Document No. 08/VBHN-BYT dated March 6, 2026 consolidates regulations on medical device management. It is one of the references healthcare facilities should review when developing procedures for equipment management, maintenance, verification, calibration, and recordkeeping.
Because regulations and regulated equipment lists may continue to change, facilities should not rely on an outdated list as their sole reference.
Step 4: Assess Quality System Requirements
In addition to legal requirements, hospitals or laboratories may have internal quality procedures requiring:
These requirements should be clearly documented in procedures and aligned with the facility's scope of operations.
Step 5: Build a Requirement Matrix for Each Device
Hospitals can create a management matrix such as:
| Equipment ID | Maintenance | Verification | Calibration | Intermediate Check | Frequency | Basis |
|---|---|---|---|---|---|---|
| TBYT-001 | Yes | Based on assessment | Yes | Yes | According to procedure | Manufacturer instructions and applicable requirements |
| TBYT-002 | Yes | Yes | As required | No | According to regulations | Relevant regulations and procedures |
| TBYT-003 | Yes | No | No | Functional testing | According to plan | Technical instructions |
The term "periodic" should not be used without specifying the actual interval or basis.
Is Calibration the Same as Adjusting Equipment?
No. This is one of the most common misconceptions.
Calibration establishes the relationship between the value indicated by the equipment and the reference value. The results may show that a device has a measurement deviation, but calibration itself does not necessarily modify or adjust the equipment.
BIPM notes that calibration should not be confused with adjustment of a measuring system. Calibration may provide the basis for determining whether adjustment is necessary, but adjustment is a separate activity.
For example, calibration results may show that:
After the equipment is adjusted, the facility will typically need to perform another evaluation or calibration to confirm the new results.
What Should Be Reviewed on a Calibration Certificate?
Managers should not only check whether the certificate is still valid. They should also review the actual results.
A calibration certificate or report may include:
The receiving department should check three main issues.
Does the Equipment on the Certificate Match the Actual Device?
Matching equipment names alone is not sufficient. The model and serial number should also be verified to prevent a certificate from being assigned to the wrong device among several identical units.
Does the Calibration Range Match the Actual Range of Use?
If the equipment is used within a particular measurement range but the certificate covers only a different range, the results may not be sufficient to assess actual use.
Do the Results Meet the Acceptance Criteria?
Having numerical results on a certificate does not automatically mean the equipment meets requirements. The facility needs criteria for comparing measurement error and uncertainty against its intended use.
If the certificate does not state whether the equipment passes or fails, the authorized department within the facility should conduct its own assessment and retain the supporting rationale.
What Should Be Checked in Verification Documentation?
When receiving verification results, the facility should review:
Information on the certificate, label, and tracking records should be consistent. If the label is damaged, lost, or unreadable, the facility should have a controlled process rather than creating a replacement label that could cause confusion.
When Should Verification or Calibration Be Repeated?
In addition to scheduled intervals, equipment may need to be reassessed when:
Not every relocation or update automatically requires recalibration. The decision should be based on an impact assessment, manufacturer instructions, and approved procedures.
Who Can Perform Verification and Calibration?
Healthcare facilities should not select service providers based solely on price or turnaround time.
When evaluating a service provider, facilities should consider:
For verification activities subject to legal requirements, the service provider must meet the applicable conditions under current regulations. For activities performed to support internal quality systems, hospitals should define clear competency criteria before entering into a contract.
Should Records Be Organized by Device or by Year?
In most cases, the most practical approach is to use both.
Each device should have a continuous lifecycle record containing:
At the same time, the technical department may maintain annual plans to monitor overall progress.
A reference data structure may include:
| Information Group | Fields to Manage |
|---|---|
| Identification | Equipment ID, name, model, serial number |
| Applicable requirements | Whether verification, calibration, or other checks are required |
| Basis | Regulations, procedures, manufacturer instructions |
| Most recent activity | Latest maintenance, verification, and calibration dates |
| Next activity | Expected date or next utilization milestone |
| Service provider | Internal team, supplier, or independent provider |
| Result | Pass, fail, deviation, or assessment status |
| Documentation | Certificate number, document link, or storage location |
| Action | Adjustment, repair, restricted use, or removal from service |
| Responsibility | Person monitoring and person approving |
If software is used, the system should generate separate alerts for each type of activity rather than combining them under a single "next maintenance" date.
Common Errors in Managing Verification and Calibration
Treating Calibration as Proof That Equipment Has Passed
Calibration results need to be evaluated against acceptance criteria. Without this step, a hospital could continue using equipment with an unacceptable measurement deviation.
Using a Maintenance Report Instead of a Calibration Certificate
A maintenance report confirms that servicing or repair work has been performed. It does not provide the same measurement data as a calibration certificate.
Monitoring Only Expiration Dates
Expiration dates are important but not sufficient. Facilities should also track scope, measurement points, results, deviation, and follow-up actions.
Failing to Label Equipment Status After Calibration
Without clear status identification, users may not know whether equipment can continue to be used or is still awaiting evaluation.
Failing to Recalibrate After Adjustment
Once equipment has been adjusted, the previous calibration results no longer represent its current condition.
Failing to Assess the Impact of Nonconforming Equipment
If a device is found to have a measurement error exceeding the permitted limit, the facility should also assess the period since the previous evaluation and the results generated during that period.
Leaving the Entire Assessment to the Service Provider
A service provider may perform measurements or verification activities, but the hospital still needs to determine whether the results are suitable for its intended use.
Verification and Calibration Control Checklist for Healthcare Facilities
Frequently Asked Questions
Are Medical Equipment Verification and Calibration the Same?
No. Verification focuses on determining whether equipment meets applicable requirements. Calibration establishes the relationship between the equipment's measurement results and reference values.
Does Equipment That Has Been Verified Still Need Calibration?
It may. This depends on the measurement function, technical requirements, verification method, and intended use. Facilities should assess each device individually.
Can Calibrated Equipment Be Returned to Use Immediately?
It should only be returned to use after the results have been evaluated and confirmed to meet the facility's acceptance limits.
Does Calibration Make Equipment More Accurate?
Not necessarily. Calibration identifies the equipment's measurement error. Changing that error may require adjustment or repair, followed by recalibration.
How Often Should Equipment Be Verified or Calibrated?
There is no single interval that applies to every device. Frequency depends on applicable regulations, manufacturer instructions, risk level, frequency of use, environmental conditions, and equipment history.
Can a Hospital Calibrate Its Own Equipment?
It may do so within a scope for which it has appropriate personnel, methods, measurement standards, technical conditions, and procedures. For activities subject to legal requirements, all applicable regulatory conditions must be met.
This article is provided for informational purposes only. Healthcare facilities and businesses should review current regulations, manufacturer instructions, and guidance from competent authorities or qualified technical organizations at the time of implementation.
From Verification and Calibration to Equipment Quality Control at PHARMEDI & HEALTHCARE VIETNAM 2026
Verification and calibration deliver value only when healthcare facilities clearly understand what aspects of a device need to be controlled, which criteria should be used to evaluate results, and which technical requirements must continue to be monitored throughout its service life. Hospitals should therefore consider maintenance, calibration, technical support, and supplier documentation from the equipment evaluation and selection stage.
At PHARMEDI & HEALTHCARE VIETNAM 2026, exhibition categories covering medical devices, laboratory and testing equipment, diagnostic technologies, smart hospitals, and healthcare support services provide hospitals, laboratories, and businesses with opportunities to explore multiple solutions in one location.
For organizations reviewing their verification and calibration processes, visiting PHARMEDI VIETNAM 2026 also provides an opportunity to discuss directly with manufacturers, distributors, and technical partners the requirements that should be clarified throughout the equipment lifecycle:
These discussions can help healthcare facilities look beyond a certificate or a single assessment at one point in time. More importantly, they can help organizations determine how to maintain equipment reliability, ensure record traceability, and control technical requirements throughout the equipment's service life.
In this way, PHARMEDI VIETNAM 2026 provides additional opportunities for technical and specialist teams to explore technologies, engage with suppliers, and better prepare verification, calibration, maintenance, and quality management requirements before selecting or commissioning equipment.
Dates: September 22–24, 2026
Venue: Saigon Exhibition and Convention Center (SECC), Ho Chi Minh City
Exhibitor Registration: https://pharmed.vn/exhibitor/application-form
Visitor Registration: https://ers-vn.informa-info.com/pha2026?cid=FB
Contact
Booth Booking: [email protected] (Thanh Thuý)
Media Support: [email protected] (Anita Pham)
Visitor Support: [email protected] (Ciel Le)
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