A Guide to IQ, OQ, PQ in Medical Device Manufacturing

In the medical device field, you must demonstrate, test, and document via a protocol supported by your quality management system (QMS) meeting ISO 13485 requirements. You do so by creating protocols (IQ, OQ, PQ), which are methods to demonstrate that the equipment being installed or used gives you a high degree of assurance that production processes will consistently manufacture products that meet quality requirements.  

At DISHER 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 of process validation, a requirement in medical device manufacturing to prove your process consistently produces safe, effective products. 

• IQ (Installation Qualification): Did we install the equipment correctly? 
• OQ (Operational Qualification): Does the equipment operate as intended across expected conditions? 
• PQ (Performance Qualification): Does the process consistently produce acceptable products in real-world conditions? 

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.  

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 processes  
• Injection molding  
• Automated assembly  
• Software-controlled equipment  

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

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 ordered 
• Utilities (power, air, water) are properly connected 
• Software versions are correct 
• Calibration is completed 
• Documentation (manuals, drawings) are in place 

It’s recommended that IQ is performed:  

• After new equipment is installed  
• After major relocation 
• After significant upgrades 

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. 

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.) 
• Define acceptable operating ranges 
• Challenge worst-case conditions 

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.  

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 operators 
• Use standard materials and procedures 
• Produce multiple batches 
• Measure product quality outcomes 

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

The Larger Process Validation Lifecycle for Medical Devices

IQ, OQ, and PQ don’t exist in isolation. They’re part of a larger validation lifecycle that connects closely with design controls, risk management (ISO 14971), and quality systems.  

That lifecycle typically includes these stages: 

1. Define requirements (user needs, design inputs)  
2. Assess risk (hat could go wrong?)  
3. Develop validation plan  
4. Execute IQ → OQ → PQ  
5. Document results  
6. Maintain and monitor the process  

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

Validation is not a set-it-and-forget-it exercise. Revalidation is required when process changes could impact product quality. Some common triggers are:  

• New equipment installation 
• New product introduction 
• Process changes 
• Software updates 
• Facility moves 
• Supplier changes 

A good rule is that if you’re unsure whether to revalidate or not, regulators will likely expect that you do.  

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 equipment 
• Number of test conditions 
• Documentation requirements 
• Internal vs. external resources 

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.  

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

Documentation is just as important as execution.  

Typical IQ, OQ, and PQ documents are:  

• Validation plan 
• IQ/OQ/PQ protocols 
• Test results and data 
• Final reports 
• Traceability to requirements 

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

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

Timeline depends on complexity, but here’s a general range:  

• IQ: Days to a few weeks 
• OQ: Weeks 
• PQ: Weeks to months 

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.  

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: 

• Quality engineers 
• Manufacturing engineers 
• Validation specialists 
• Operators 
• Suppliers (in some cases) 

Startups and small businesses—you may not have all these roles in-house. That’s okay. You still need expertise, but there are plenty of external resources you can turn to.  

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 team to start a conversation.