Purchase Order Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Purchase Order Procedure establishes the process for purchasing materials, products or services and the methods utilized to maintain purchasing data. The Purchase Order Procedure applies to all purchase orders placed by the Purchasing Department.

• ISO 13485:2016 aligned

• FDA QMSR aligned

• MS Word Format

• Includes Applicable Form

• Instant Download - Digital Content

The ISO 13485:2016 Purchase Order Procedure establishes the process for purchasing materials, products or services and the methods utilized to maintain purchasing data.

Purchase Order Procedure - Overview

The Purchase Order Procedure applies to all purchase orders placed by the Purchasing Department. The procedure provides instruction for verifying supplier approval status, the required content for purchase orders, and the required notice to suppliers for notification of any change in product or processes.

Purchase Order Procedure - Compliance

The Purchase Order Procedure is ISO 13485:2016 and FDA 21 CFR Part 820 aligned.

For more information about our Purchase Order Procedure contact us at [email protected]

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.