Installation Qualification IQ Procedure | ISO 13485 | FDA QMSR

Qualify equipment installation for medical device manufacturing and release testing with this editable Installation Qualification (IQ) Procedure and forms. It addresses new, relocated or modified equipment; utilities, manufacturer specifications, calibration and preventive-maintenance setup, safety, deviations and summary reports.

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Supplied as two editable Microsoft Word documents (the procedure and one form) in a digital download.

Equipment installation checks and qualification records

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.

• Equipment and utility installation checks

• Safety, calibration and supplier-document review

• IQ protocols, deviations and summary reports

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.

For the broader validation strategy, see the Process Validation Procedure. The Validation Protocol and Report Procedure addresses protocol and final-report structure.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Equipment IQ, Calibration and Preventive Maintenance for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in ISO 13485 Process Validation Procedure Bundle. Explore the bundle for the related documents.