IQCP and the Manufacturer's QC Requirements
An IQCP can't set QC less stringent than the manufacturer's instructions. That rule comes from CMS, the CDC/CMS workbook and the CAP. Manufacturer data and risk tools can feed your risk assessment, but your own in-house data must still support the QC frequency, and the director must approve it.
The manufacturer's instructions are the floor for every IQCP. Here's how to use them without over-relying on them.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
The floor rule
CMS: the QC plan may not be less stringent than the manufacturer's QC requirements (CMS IQCP Frequently Asked Questions (Aug 2016)).
CDC/CMS: labs can't set QC procedures less stringent than the manufacturer's (Developing an IQCP - A Step-By-Step Guide (CDC/CMS workbook)).
CAP: labs must follow all manufacturer instructions for internal and external QC, at minimum (the CAP's public IQCP FAQ (updated Nov 2024)).
SOM Appendix C guidance quoted by CMS: meet regulatory requirements and comply with the manufacturer's requirements where they don't conflict.
Reading the package insert
Pull out: required external QC frequency and trigger events, internal control behavior, calibration and calibration verification, maintenance and function checks, specimen and storage limits, and interferences. Westgard's outside review of a point-of-care IQCP found that a reviewed POC IQCP left out a manufacturer minimum requirement, so cite each one.
Manufacturer risk tools
They're useful inputs, but the CAP says they can't stand alone, and CMS requires lab-specific data.
Requirements vs recommendations
SOM guidance distinguishes manufacturer requirements (must follow) from recommendations (encouraged). Document which each item is.
IQCP and the Manufacturer's QC Requirements checklist
☐ List every manufacturer QC requirement and trigger
☐ Mark requirements vs recommendations
☐ Check that the QC plan meets each requirement
☐ Include non-QC requirements (maintenance, probe checks)
☐ Use manufacturer risk info only as a supplement
☐ Re-check when the package insert changes
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
Can IQCP reduce QC below the manufacturer's instructions?
No. CMS, CDC and the CAP all say it can't.
Can I use the manufacturer's IQCP risk tool?
Yes, as a supplement. The CAP says it can't replace the lab's own risk assessment.
What if the manufacturer requires no external QC?
CLIA still applies. You need either default CLIA QC or an IQCP backed by your own data.
What if the package insert changes?
Reassess the IQCP and update the QC plan if the new requirements are stricter.
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