IQCP Template: Section-by-Section Outline

An IQCP template needs three required parts, a risk assessment, a quality control plan and a quality assessment, plus the test system details and the laboratory director's signature and date. CMS doesn't mandate any format, so labs can use the CDC/CMS workbook, accreditor tools or their own layout.

CMS says it doesn't require a specific IQCP format (CMS IQCP Frequently Asked Questions (Aug 2016)). What surveyors and inspectors look for is content. This outline is our own; use it alongside the official workbook.

Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.

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Template outline

1. Header: lab name, CLIA number, test system (make, model, analytes), specialty/subspecialty, locations and devices covered, version and effective date.

2. Supporting information: manufacturer instructions and QC requirements, verification study summary, historical QC and internal-control data, PT history, maintenance and function-check records, complaint and corrective action history.

3. Risk assessment: a table with one row per potential failure, grouped by the five components (specimen, test system, reagent, environment, testing personnel) and by phase (preanalytic, analytic, postanalytic). Columns: failure, possible cause, how likely and how severe, how it's detected or prevented, and the evidence. CMS says a formal risk acceptability matrix isn't required, but you have to show how you evaluated frequency and impact.

4. Quality control plan: at minimum, the number, type and frequency of control materials and the acceptance criteria (per the Developing an IQCP - A Step-By-Step Guide (CDC/CMS workbook)). Add new lot/shipment QC, trigger events, and the activities the plan relies on (training, competency, maintenance, calibration, PT).

5. Approval: laboratory director signature and date before use. CMS says this can't be delegated. The CAP also expects biennial reapproval.

6. Quality assessment: monitors, review frequency, who reviews, and what triggers reassessment.

7. Revision log: what changed, why, data reviewed, approval date.

Free official and professional templates

Templates are starting points. CMS says an IQCP must reflect your own lab's data, and the CAP says manufacturer risk information can supplement your risk assessment but can't replace it. See a worked IQCP example and the risk assessment guide.

IQCP Template checklist

  • ☐ Header with CLIA number, test system, analytes, sites and devices

  • ☐ Manufacturer QC requirements attached and cited

  • ☐ Risk table covering all five components and all three phases

  • ☐ Evidence column linking each mitigation to a record

  • ☐ QC plan with number, type, frequency and acceptance criteria

  • ☐ New lot/shipment and trigger-event QC defined

  • ☐ Director signature and date

  • ☐ Quality assessment monitors and schedule

  • ☐ Revision log

  • ☐ CAP labs: CAP IQCP list form updated

CDC resources on CLIA

  • CDC's overview of the CLIA program: CDC explains that CLIA applies to every U.S. site that tests human specimens to assess health or to diagnose, prevent, or treat disease. It also explains that CDC supports the program alongside CMS and FDA.

  • CDC on CLIA test complexity categories: CDC explains how FDA scores tests as moderate or high complexity using seven criteria. It also notes that lab-developed or modified tests default to high complexity, and that moderate and high complexity standards differ only in personnel requirements.

  • CDC's free CLIA educational materials: CDC offers brochures and booklets on waived testing, PPM, and IQCP.

Frequently asked questions

Is there an official IQCP template?

CMS doesn't require a format. The CDC/CMS workbook 'Developing an IQCP - A Step-By-Step Guide' provides example worksheets that labs may use.

What sections must an IQCP include?

A risk assessment, a quality control plan and a quality assessment. All three are required, per CMS.

Can I use a manufacturer's IQCP template?

Manufacturer information can supplement your risk assessment, but the CAP says it can't be used alone, and CMS requires your own in-house data.

Does CMS require a risk matrix?

No. CMS says a risk acceptability matrix isn't required; you must show how you evaluated the frequency and impact of errors.

What is the CAP IQCP form?

The CAP requires accredited labs to keep a List of Individualized Quality Control Plans form, available through its e-LAB Solutions Suite.

Can the QC plan sit inside the test procedure?

The CAP says yes, as long as the required parts are included and the laboratory director signs and dates it.

Official sources and further reading

Related IQCP guides

Talk to an IQCP consultant

Sound Lab Consultants helps labs nationwide build, review and maintain IQCPs from their own data and the official CMS and CDC guidance.

Sound Lab Consultants, PO Box 2135, Chandler, AZ 85244

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