Installation Qualification Procedure | ISO 9001:2026 + ISO 13485:2016

Plan, execute, review and approve installation qualification for new, relocated or significantly modified equipment and ancillary systems. This editable installation qualification procedure is part of the A.P. Lyon Dual-Standard QMS family for ISO 9001:2026 and ISO 13485:2016.

Building a set? Use Build Your QMS to choose 5–9 procedures for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. Discounts are applied at checkout.

Scope and intended use

This procedure applies to new, relocated and significantly modified manufacturing, inspection and test equipment, including associated utilities, accessories and software. Engineering and Quality Assurance shall document the extent of IQ and any needed operational qualification (OQ), performance qualification (PQ), process validation or software validation based on intended use, change impact and risk.

What you receive

One digital ZIP containing the editable SOP 7-014-C Word procedure and a PDF copy. The gallery shows representative pages from the document.

Additional editable files included in this ZIP:

• FORM 0014-C.docx

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.

Related procedures

These procedures address connected work and are sold separately:

• Record Retention Procedure

• Measurement & Metrological Confirmation

• Medical Device Process Validation Procedure

Systems containing this procedure

• Dual-Standard QMS — Base

• Dual-Standard QMS — Base Plus

• Dual-Standard QMS — Design Plus

• Dual-Standard QMS — Manufacturing

• Dual-Standard QMS — Manufacturing Plus

A system package includes this procedure with other documents. Review its content list before purchasing both.

Before implementation

Adapt responsibilities, process steps, acceptance criteria and records to your organization, device and intended markets. Confirm the applicable standards and regulatory requirements before approval and use. This download supplies documentation, not executed testing, regulatory authorization or certification.