Process Validation IQ OQ PQ Template for Medical Device Manufacturing
When the result of a process cannot be fully checked by later inspection, ISO 13485 requires you to validate it. This template builds an IQ, OQ and PQ outline you can complete and export, so the protocol starts from a sound structure.
Fill in
Process Validation IQ OQ PQ Template
Validation Protocol PV-2026-014
Company: Meridian Orthopedics Inc. Process: Ultrasonic welding of catheter hub to shaft Equipment: Ultrasonic welder UW-220, asset 4471 Date: 2026-10-20
Purpose and scope
This protocol defines the installation, operational and performance qualification of Ultrasonic welding of catheter hub to shaft. The process output cannot be fully verified by later inspection, so the process is validated and monitored.
Product requirement
Weld joint tensile strength of at least 15 N, no leaks at 300 kPa pressure test, no visible flash on the bore.
Installation qualification (IQ)
| Item | Requirement | Result | Pass or fail |
|---|---|---|---|
| Equipment identification | Model, serial number, asset tag match | ||
| Utilities | Power, air and environment as specified | ||
| Calibration | Instruments calibrated and in date | ||
| Software and controls | Version recorded and secured | ||
| Documentation | Manuals and maintenance plan on file |
Operational qualification (OQ)
Critical parameters and ranges to challenge: Amplitude 60 to 80 percent, weld time 0.4 to 0.8 s, hold time 0.5 s, trigger force 40 to 60 N.
Run the process at the low and high limits, and at nominal, and record the output at each setting to define the operating window.
OQ test record
| Setting | Parameter values | Sample size | Result | Pass or fail |
|---|---|---|---|---|
| Low limit | ||||
| Nominal | ||||
| High limit |
Performance qualification (PQ)
Runs and sample size: Three consecutive lots, 30 units per lot, rationale per sampling plan SP-07
Acceptance criteria: All units meet the requirement. Process capability Ppk of at least 1.33 on tensile strength. No unexplained failures.
Deviations and conclusion
Record every deviation with its justification. The process is validated only if all acceptance criteria are met.
Approvals
This is an outline to speed up protocol writing, not legal advice or a replacement for your validation procedure. Add your own risk based rationale for sample sizes, and review GHTF/IMDRF process validation guidance and ISO 13485 clause 7.5.6 for what to document.
Process data into validation reports
Optional: a short review of how process and inspection data could feed validation and monitoring reports.
Optional. The tool and every export work without this. No spam.
How to use this template
Enter the process, equipment, protocol number and the requirement the process must meet. List the critical parameters, the PQ run plan and the acceptance criteria. Export to Word or PDF, then fill the IQ checks and OQ results as you test. Approve the protocol before any validation run starts, and do not begin PQ until IQ and OQ pass. If anything is changed, assess whether revalidation is needed.
- Write acceptance criteria before running anything
- Run OQ at the low, nominal and high limits
- Use three or more PQ runs with a stated rationale
- Record every deviation and how it was resolved
What IQ, OQ and PQ mean
Installation qualification confirms the equipment is installed correctly with the right utilities, calibration and documentation. Operational qualification challenges the process parameters across their limits to show the equipment produces acceptable output over a defined window. Performance qualification runs the process under normal production conditions, with real operators and materials, to show it repeatably meets the requirement. Together they form the evidence required by ISO 13485 clause 7.5.6 and GHTF and IMDRF process validation guidance.
Sizing and capability
A sample size should come from risk, not habit. For attribute results a confidence and reliability statement such as 95 percent confidence with 95 percent reliability needs 59 samples with zero failures. For variable data, a capability index such as Ppk at or above 1.33 is a common target. State the rationale in the protocol so an auditor can follow your logic.
Common mistakes
Frequent weaknesses are vague acceptance criteria, an OQ that tests only nominal settings, PQ lots built under special supervision, and no plan to monitor the process after validation. Also watch for changes in material, software or tooling after approval: each needs a documented assessment of whether revalidation is required. Equipment qualification alone is not process validation.
Frequently Asked Questions
When is process validation required?
When the output of a process cannot be fully verified by later monitoring or measurement, and processing deficiencies would only show up after use. Sterilization, welding, sealing and cleaning are typical examples in medical device manufacturing.
How many PQ runs are needed?
Three consecutive successful runs are a common convention, but regulators expect a rationale, not a number. Use risk and process variability to justify the number of runs and the sample size in each.
Do I need revalidation after a change?
You need a documented assessment after any change that could affect the process, such as new equipment, material, software or parameters. The assessment decides whether to revalidate fully, partially, or only justify why not.
Is software validation part of this?
If software controls the process or records its results, it must be validated for its intended use. That can be covered in the IQ and OQ or in a separate software validation, depending on your procedure.
If your process parameters and inspection results are captured in MES or ERP, Netray can help pull them into validation reports and ongoing monitoring on your own infrastructure.
Related Tools
Sterilization Load Record Template
A load record for sterilization cycles listing load contents, cycle parameters, indicator results and release decision, with signatures.
Quality & InspectionDevice History Record (DHR) Template
Build a device history record for one lot or serial number: quantities, dates, labeling, acceptance and release sign-off. Exports to PDF or Word.
Quality & InspectionISO 14971 Risk Management Worksheet
An editable hazard analysis table that scores initial and residual risk from severity and probability and exports to Excel.
Engineering & PLMDesign History File Index Template
An editable index of the records that make up a medical device design history file, with status, owner and review date for each document.
More Quality & Inspection tools
See all- CAPA Corrective and Preventive Action Form Template
- ISO 13485 Internal Audit Checklist
- Medical Device Complaint Handling Form Template
- Medical Device Design Verification Protocol Template
- Medical Device Supplier Evaluation Scoring Worksheet
- Medical Device Cleanroom Environmental Monitoring Log
- Medical Device Accelerated Aging Calculator (ASTM F1980)
- Medical Device Success Run Validation Sample Size Calculator
- Sterilization D-Value and SAL Log Reduction Calculator