Purchase Order Procedure | ISO 13485 | FDA QMSR

Use this editable ISO 13485 Purchase Order Procedure to document how the Purchasing Department prepares, reviews and approves orders for materials, products and services.

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Supplied as two editable Microsoft Word documents, the procedure and an Approved Supplier List (LIST 0004) document, in a digital download.

Purchase-order preparation and approval

It covers supplier approval checks, required purchase order content and notification requirements for supplier changes to products or processes.

The procedure describes how purchasing verifies approved-supplier status, prepares a purchase order that identifies the item, specification and revision, and routes the order for the appropriate review and financial approval. Quantity, price, delivery and required supplier documentation are addressed alongside technical requirements. The resulting purchase record gives receiving and quality personnel a defined basis for checking delivered materials and for following up on an incorrect or incomplete order.

Standards and frameworks addressed: ISO 13485:2016; FDA QMSR.

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.

Related purchasing workflow

Use the Supplier Management Procedure to evaluate and approve suppliers, then the Receiving and Identification of Materials Procedure to check incoming deliveries against purchasing information.

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 Medical Device Supplier Management and Purchase Orders for workflow guidance, a checklist and common mistakes.