Written by
Leah Westover
AVP, Product & Market Strategy
A Fresh Look at IQCPs with IQE
IQCPs don’t always get the attention they deserve. Often viewed as just a regulatory obligation, IQCPs are actually powerful tools for managing risk, strengthening quality control, and maintaining compliance across all phases of laboratory testing.
That’s why we’ve built a fully customizable IQCP template into IQE — to make the process easier, more insightful, and more useful for your lab.
What is an IQCP?
An Individualized Quality Control Plan (IQCP) is a risk-based approach to laboratory quality management. It allows your lab to evaluate risks in the pre-analytical, analytical, and post-analytical phases, then develop customized QC strategies that are effective and defensible.
What’s in the IQCP Template?
Our built-in IQE form includes everything your lab needs to build, maintain, and review an IQCP — no spreadsheets or binders required. Our template walks you through the full IQCP process, step by step. You’ll begin by entering general information about the test method, location, and specimen types. From there, you’ll assess risk in three key areas:
- Pre-analytical risks like labeling errors, transport delays, or misidentification
- Analytical risks such as instrument malfunction, calibration issues, or operator error
- Post-analytical risks including reporting delays, transcription errors, or LIS issues
For each category, you’ll select potential risks, describe current controls in place, and score the likelihood, severity, and residual risk.
Next, you’ll outline your internal quality control plan. You can define what types of QC materials are used, how often QC is performed, what criteria determine pass/fail, and what corrective actions are required. It also allows you to document roles and responsibilities, such as who reviews QC data and how records are maintained.
Finally, the form guides you through creating a Quality Assessment Plan. You’ll indicate how frequently your IQCP will be reviewed, who’s responsible for reviewing it, and what data points will be evaluated — like PT results, turnaround times, nonconformance trends, and equipment issues. You’ll also document the follow-up or escalation process and complete a formal attestation signed by the lab director.
Why It Works
This isn’t just a static form. IQE’s IQCP template is interactive, flexible, and fully audit-ready. It supports version control, electronic approvals, and links directly to related documentation like SOPs, Events, and Data Logs.
You can update your IQCP anytime a method, location, or analyzer changes. And you can demonstrate — with full traceability — that your lab is actively managing quality and risk.
Make It Work for Your Lab
If you’re still using binders, spreadsheets, or outdated PDFs, IQE offers a better way. Start using the IQCP template in IQE today to bring structure and clarity to your risk management efforts. It’s customizable, inspection-ready, and part of our broader quality ecosystem designed to support your lab's quality mangement initiatives.
Ready to explore how IQE’s IQCP form can help your lab manage risk and maintain compliance? Check out our IQE Template Library to import and customize our Individualized Quality Control Plan (IQCP) Form today!