IQ, OQ, and PQ Validation Services

IQ OQ PQ validation and documentation built around what transfers with your mold.

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Formal Qualification for Regulated Production Programs

Detail Mold & Manufacturing conducts IQ OQ PQ validation for regulated injection molding programs under ISO 9001:2015 and ISO 13485:2016-certified quality management systems. Medical device manufacturing is the primary application, though any regulated program requiring documented qualification across installation, operation, and production phases is in scope.

We operate under our customers’ FDA frameworks rather than carrying direct FDA authorization. Qualification documentation is produced to the standard your program requires and structured to support your regulatory submission package.

Start Your Qualification Program at Detail Mold

Detail Mold’s IQ OQ PQ validation services are structured around your program’s regulatory requirements. Bring your mold and qualification protocol and we will scope the engagement.

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What Each Qualification Phase Certifies

Each phase of the process certifies something distinct and produces documentation with different portability. What transfers with the mold and what stays with the process matters for how you plan the program.

  • IQ – Installation Qualification

    Verifies the mold, press, and ancillary equipment are installed correctly and configured to specification. We document the production environment as it exists at qualification, establishing a baseline package built to move with the mold if your program transfers to another facility later.

  • OQ – Operational Qualification

    Verifies the process operates within its established bounds. We carry the high and low parameter points from process development directly into OQ testing, confirming the process window is real and reproducible rather than starting the bounds-setting work over. Like IQ, this documentation is built to transfer with the mold if your program needs it to.

  • PQ – Production Qualification

    Certifies that this mold, on this press, running this process, consistently produces conforming parts under production conditions. If your program needs full production certification rather than a portable qualification package, we run PQ through to completion here, formally approving the process for regulated output before it goes live.

Qualification Requirements by Industry

Formal IQ, OQ, and PQ validation is driven by what your industry and customer require documented before parts ship. Medical device manufacturing is where this comes up most consistently, though it isn’t exclusive to that industry. Here’s a closer look at what you might need:

  • Medical device programs typically require the full IQ, OQ, and PQ sequence, often tied to a customer’s own quality system or an FDA submission package. We structure documentation to support that regulatory framework directly.
  • Aerospace, defense, and other regulated programs may require one or more qualification phases depending on the customer’s own process control standards, even without a formal medical device requirement driving it.
  • Non-regulated production programs generally don’t need formal qualification documentation, though customers can request it for internal process control purposes.

FAQs

We can work from an existing protocol or help scope one based on your program’s regulatory requirements. Bring what you have, an established protocol, a regulatory framework you’re qualifying against, or just a general sense of what your customer or auditor will require, and we’ll structure the qualification phases around it before testing begins.

The process window established during process development directly feeds the OQ phase. The high and low parameter points developed and verified during DOE and CpK studies become the bounds within which operational qualification is conducted. Running process development before qualification produces a tighter, more defensible OQ package.

Request a Quote for Your Next Project

Share your project details using the form below and our team will follow up directly. For questions about scope or capabilities, you can also reach us at 512.255.0525.

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