Installation Qualification IQ Procedure | ISO 13485 | FDA QMSR

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The ISO 13485:2016 Installation Qualification (IQ) Procedure governs the installation of equipment used to manufacture medical devices and all test equipment used to release product.

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Installation Qualification Procedure Overview

The Installation Qualification Procedure applies to the installation of new equipment, moving or relocating equipment, or after equipment modifications. The Installation Qualification (IQ) Procedure provides instruction on the requirements of conducting Installation Qualifications (IQ's). The Installation Qualification (IQ) Procedure ensures equipment is installed with appropriate utilities, is entered into the calibration and preventive maintenance systems, is installed in accordance with manufacturers requirements, and is installed with consideration to operator space requirements and safety.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.