ISO 13485 Bundle | All templates for ISO 13485:2016

Streamline your Quality Management System (QMS) implementation with our ISO 13485:2016 Complete Template Bundle. This comprehensive package contains all the essential templates you need to establish, manage, and maintain a fully ISO 13485-compliant QMS for medical device manufacturing, regulatory compliance, and quality assurance. Designed to help organizations meet the requirements of ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820, this bundle ensures efficiency, consistency, and full audit readiness.

✔ Document Control & Change Management Templates – Master Document List, Change Control Log, SOPs.

✔ Risk Management & Compliance Tools – CAPA Procedures, Non-Conformance Reports, Risk Analysis.

✔ Internal Audit & Compliance Templates – Audit Plan, Audit Reports, Audit Schedule, CAPA Tracking.

✔ Supplier Management & Purchasing Procedures – Supplier Evaluation, Goods In/Out, Purchasing Controls.

✔ Production & Process Control Documents – Batch Records, Calibration Logs, Validation Protocols.

✔ Post-Market Surveillance & Regulatory Reporting – Complaint Handling, PMS Plan, Vigilance Reporting.

✔ Training & Competency Records – Training Matrix, Job Descriptions, Employee Induction.

✔ Editable Digital Format – Fully customizable for different medical device classifications and business models.

This all-in-one ISO 13485:2016 template bundle is perfect for quality managers, regulatory professionals, and medical device manufacturers, ensuring effortless QMS compliance and audit readiness.

Download the ISO 13485:2016 Complete Template Bundle today and accelerate your QMS implementation with confidence!