ISO 13485 Quality Management System Manual

The ISO 13485:2016 Quality Management System Manual serves as the top-level document for an organization's quality management system and its standard operating procedures.

How it is used

Adapt the manual to reflect your company's activities and the markets it serves. It provides the overarching quality-system framework; it is a standalone manual rather than a full procedure package.

Format

• Microsoft Word and PowerPoint formats

• Digital download

Compare complete quality-system packages or ask about the manual.

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.