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.
The manual establishes the high-level map of the quality system, including management responsibility, resources, product realization, measurement and improvement, and the interaction of those processes. It provides a framework for referencing the organization's approved procedures and documenting scope and exclusions or nonapplicable activities. Adapt the roles, process map, products and regulatory markets to the actual business before issuing it as a controlled quality manual.
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.
Microsoft Word and PowerPoint formats
Digital download
Compare complete quality-system packages or ask about the manual.
Related procedures for implementation
The manual provides the high-level framework. For specific workflows, see the separately sold Organization, Responsibilities, and Authority Procedure for defined roles, the Document Control Procedure for controlled documents, and the Management Review Procedure for periodic leadership review.
