What is the difference between IQ, OQ and PQ?

IQ shows the equipment meets its specifications and is installed correctly, with components and documents in place. OQ shows it operates correctly. PQ shows the process performs as intended, consistently, over time.

Can tests move between IQ, OQ and PQ to save hours?

Yes, from IQ to OQ or from OQ to PQ, when a clear, approved justification is documented in the validation plan. Enter the saving as fewer protocol and report hours in the phases you combine.

Which equipment needs IQ, OQ and PQ?

Equipment running a process whose results cannot be fully verified by later inspection and test, such as sterilization. FDA's quality system inspection guide (1999) directs investigators to confirm such processes were validated.

Where do vendor installation and commissioning fees go?

In devices and outside fees, with lab tests and consumed devices. Keep phase hours for your own team's time, so the phase rows compare effort, not invoices.

MedTech Manufacturing calculator

IQ OQ PQ Qualification Cost Calculator

Estimate equipment qualification cost before you submit a capital request or sign a validation quote. You need hours per phase, a burdened engineering rate, consumed devices and outside fees, and the approved budget.

What this calculator does

Cost to qualify equipment through IQ, OQ and PQ, phase by phase, against your approved budget.

Formula used

IQ, OQ and PQ engineering cost = that phase's hours × engineering rate
Total engineering hours = IQ hours + OQ hours + PQ hours
Total qualification cost = total engineering hours × engineering rate + devices and outside fees
Budget remaining = qualification budget − total qualification cost; negative means over budget

Inputs explained

IQ Hours: Protocol, installation and utility checks, calibration review and report.
OQ Hours: Protocol, challenge runs at the operating limits, data review and report.
PQ Hours: Protocol, runs under routine conditions, sample analysis and report.
Engineering Rate: Burdened hourly cost of validation engineers, or a consultant's rate.
Devices and Outside Fees: Devices consumed in OQ and PQ, plus lab and vendor invoices.
Qualification Budget: Validation line in the approved capital request.

How to use the result

Best suited to capital request for new production equipment, requalification after an equipment move or major repair, checking a validation consultant's quote.
Excludes failed runs that force a protocol to be executed again; add their hours if your history shows them. Excludes the equipment price and production time lost while the equipment is qualified.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

What is the difference between IQ, OQ and PQ? IQ shows the equipment meets its specifications and is installed correctly, with components and documents in place. OQ shows it operates correctly. PQ shows the process performs as intended, consistently, over time.
Can tests move between IQ, OQ and PQ to save hours? Yes, from IQ to OQ or from OQ to PQ, when a clear, approved justification is documented in the validation plan. Enter the saving as fewer protocol and report hours in the phases you combine.
Which equipment needs IQ, OQ and PQ? Equipment running a process whose results cannot be fully verified by later inspection and test, such as sterilization. FDA's quality system inspection guide (1999) directs investigators to confirm such processes were validated.
Where do vendor installation and commissioning fees go? In devices and outside fees, with lab tests and consumed devices. Keep phase hours for your own team's time, so the phase rows compare effort, not invoices.

Last reviewed 2026-10-01.