What is Installation Qualification (IQ)?

Installation Qualification Definition

The FDA provides guidance applicable to the validation of medical device software or the validation of software that is used to design, develop, or manufacture medical devices. Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are the three independent and documented procedures used to validate that software is:

  1. Installed correctly
  2. Meets its design requirements and specifications
  3. Operates the way in which it was designed under load

The IQ records the installation of the software, and ensures that the installation follows the correct steps.

Related Terms

  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Software Validation
  • Verification and Validation
  • Validation Protocol
  • ISO 9000