91³Ô¹Ï

In theÌýmedical deviceÌýfield, you mustÌýdemonstrate, test, and document via a protocol supported by your quality management system (QMS) meetingÌýISO 13485 requirements. You do so by creating protocolsÌý(IQ, OQ, PQ), which are methods toÌýdemonstrateÌýthatÌýthe equipment being installed or used gives you a high degree of assurance that production processes will consistently manufacture products that meet quality requirements.ÌýÌý

At 91³Ô¹Ï Engineering, we are experienced in writing and executing IQ, OQ, and PQ protocols that meet ISO 13845 requirements, giving customers that assurance. This guide explains what IQ, OQ, and PQ mean, why they matter, and how to approach them. 

What Do IQ, OQ, and PQ Mean in Medical Device Manufacturing?

IQ, OQ, and PQ are three stages ofÌýprocess validation, aÌýrequirement inÌýmedical device manufacturingÌýto prove your process consistently produces safe, effective products.Ìý

• IQ (Installation Qualification):ÌýDid we install the equipment correctly?Ìý
• OQ (Operational Qualification):ÌýDoes the equipmentÌýoperateÌýas intended across expected conditions?Ìý
• PQ (Performance Qualification):ÌýDoes the process consistently produce acceptable products in real-world conditions?Ìý

In other words, IQ ensures the equipment is set up right, OQ ensures it runs as expected, and PQ ensures it continues to work in production.ÌýÌý

Why Are IQ, OQ, and PQ Required for Medical Devices?

The FDA (21 CFR Part 820) and ISO 13485 both require manufacturers to validate processes that can’t be fully verified through inspection alone. 

In plain terms: If you can’t check every product without destroying it—or if defects might not be obvious—you must prove your process is reliable. 

This is especially important for: 

• Sterilization processesÌýÌý
• Injection moldingÌýÌý
• Automated assemblyÌýÌý
• Software-controlled equipmentÌýÌý

Skipping or rushing validation can lead to FDA warning letters, delayed product launches, costly rework, and/orÌýloss of customer trust.Ìý

IQ, OQ, PQ Comparison Chart

Stage	Focus	Key Question	Timing
IQ	Installation	Was it set up correctly?	After installation
OQ	Operation	Does it function properly?	Before production
PQ	Performance	Does it consistently product good product?	During production simulation

About Installation Qualification (IQ)

IQ is the foundation. It verifies that your equipment is installed correctly and ready to operate. 

It includes verifying that:  

• Equipment specifications match what was orderedÌý
• Utilities (power, air, water) are properly connectedÌý
• Software versions are correctÌý
• Calibration is completedÌý
• Documentation (manuals, drawings) are in placeÌý

It’sÌýrecommended that IQ is performed:ÌýÌý

• After new equipment is installedÌýÌý
• After major relocationÌý
• After significant upgradesÌý

For example, if you install a new automated assembly line, IQ will ensure everything is set up according to manufacturer’s specifications before you even turn it on.Ìý

About Operational Qualification (OQ)

OQ answers a different question: Does the equipment work correctly across all expected operating conditions? 

During OQ, you:  

• Test process parameters (temperature, pressure, speed, etc.)Ìý
• Define acceptable operating rangesÌý
• Challenge worst-case conditionsÌý

For example, for an injection molding process, OQ might test high and low temperature limits, different cycle time, and pressure variations. The goal is to understand how the process behaves and define safe operating windows.ÌýÌý

About Performance Qualification (PQ)

PQ is where everything comes together. It answers: Can this process consistently produce good products under normal production conditions? 

During PQ, you:  

• Run production using trained operatorsÌý
• Use standard materials and proceduresÌý
• Produce multiple batchesÌý
• Measure product quality outcomesÌý

This is the closest simulation to real-world manufacturing, and therefore what regulators care about the most.ÌýIt’sÌýproof that your process is ready for routine use.Ìý

The Larger Process Validation Lifecycle for Medical Devices

IQ, OQ, and PQÌýdon’tÌýexist in isolation.ÌýThey’reÌýpart of a larger validation lifecycle that connects closely with design controls, risk management (ISO 14971), andÌýquality systems.ÌýÌý

That lifecycle typically includes these stages: 

1. Define requirementsÌý(user needs, design inputs)ÌýÌý
2. Assess risk (hat could go wrong?)ÌýÌý
3. Develop validation planÌýÌý
4. Execute IQ → OQ → PQÌýÌý
5. Document resultsÌýÌý
6. Maintain andÌýmonitorÌýthe processÌýÌý

When Do You Need to Perform IQ, OQ, and PQ?

Validation is not a set-it-and-forget-it exercise. Revalidation isÌýrequiredÌýwhen process changes couldÌýimpactÌýproduct quality. Some common triggers are:ÌýÌý

• New equipment installationÌý
• New product introductionÌý
• Process changesÌý
• Software updatesÌý
• Facility movesÌý
• Supplier changesÌý

A good rule is that ifÌýyou’reÌýunsure whether to revalidate or not, regulators willÌýlikely expectÌýthat you do.ÌýÌý

How Much Do IQ, OQ, and PQ Activities Cost?

Costs can vary widely depending on your product and process.  

Factors that impact cost include:  

• Complexity of equipmentÌý
• Number of test conditionsÌý
• Documentation requirementsÌý
• Internal vs. external resourcesÌý

That said, a rough estimate you can expect to pay for a simple validation is between $10,000 – $50,000. For a more complex system, you may be in the $50,000 – $200,000 range.ÌýÌý

What Documentation Is Required for IQ, OQ, and PQ?

Documentation is just as important as execution.  

Typical IQ, OQ, and PQ documents are:  

• Validation planÌý
• IQ/OQ/PQ protocolsÌý
• Test results and dataÌý
• Final reportsÌý
• Traceability to requirementsÌý

In each of these documents, auditors will look for clear rationale, complete records, and evidence of review and approval.ÌýÌý

How Long Does IQ, OQ, and PQ Take to Complete?

Timeline depends on complexity, butÌýhere’sÌýa general range:ÌýÌý

• IQ: Days to a few weeksÌý
• OQ: WeeksÌý
• PQ: Weeks to monthsÌý

You will save time by planning validation early, rather than at the last minute. Too often, we see IQ, OQ, and/or PQ delays due to waiting on equipment or materials, poor planning, repeated failed tests, and documentation gaps.ÌýÌý

Who Is Involved in IQ, OQ, and PQ Execution?

Validation is a team effort! Here are some key roles that are typically included in the process:Ìý

• Quality engineersÌý
• Manufacturing engineersÌý
• Validation specialistsÌý
• OperatorsÌý
• Suppliers (in some cases)Ìý

Startups and small businesses—you may not have all these roles in-house.ÌýThat’sÌýokay. You still needÌýexpertise, but there are plenty of external resources you canÌýturnÌýto.ÌýÌý

Should You Handle IQ, OQ, and PQ In-house or Work with a Partner?

This depends on your resources and experience.  

The benefits of handling IQ, OQ, and PQ in-house are that you have more control, and you can build more internal knowledge throughout the process. However, you may run into issues with limited experience, slower execution, and a higher risk of mistakes.  

By working with a partner, you are more likely to enjoy faster setup, proven frameworks (they’ve done the same thing for a number of companies before), and therefore reduced risk.  

For startups, an external resource can accelerate your timeline and ensure your accuracy. For more established teams, it can fill gaps or support your more complex validations. 

Ready to Get Your Validation Process Right?

Whether you’re launching your first medical device or scaling an existing product, IQ, OQ, and PQ don’t have to slow you down or feel overwhelming. With the right approach, they provide a clear path to building a reliable process and earning trust with regulators and customers. 

If you’re unsure where to start or want a second set of eyes on your medical device validation strategy, our team can help. We work alongside startups and established manufacturers to simplify validation, reduce risk, and keep projects moving. 

Reach out to our teamÌýtoÌýstart a conversation.Ìý