ISO 13485 Templates

These ISO 13485 templates provide a starting structure for a medical-device quality management system. The collection covers common controlled documents and records such as the quality manual, document and record control, management review, training, supplier controls, design and development, complaints, CAPA, internal audits, production controls, and post-market processes.

Use them as a connected system rather than a folder of independent SOPs. Define who performs each activity, which inputs trigger it, which record proves it happened, how it connects to risk management and regulatory requirements, and which metric shows whether the process is effective. Align terminology, roles, forms, and approval workflows across the set before release.

The templates do not make an organisation ISO 13485 compliant and do not replace the standard. Purchase and assess the edition and regulatory requirements applicable to your markets, then tailor the documents to your devices, sites, outsourced processes, software tools, and actual operating model. Delete instructions and example text, validate electronic workflows where needed, train users on approved versions, and retain objective evidence that the procedures are followed.