Training Record Template - ISO 13485

Maintain comprehensive training records and ensure regulatory compliance with our ISO 13485:2016 Clause 6.2 Training Record Template. Training and competency management are critical for ensuring that personnel involved in medical device manufacturing, quality management, and regulatory compliance are properly trained and qualified. This structured template helps organizations track employee training, certifications, and competency levels, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Training Record Template – Covers key ISO 13485:2016 Clause 6.2 requirements.

✔ Employee Information & Job Role Section – Track personnel details and assigned responsibilities.

✔ Training Course & Certification Log – Document training topics, trainers, and completion dates.

✔ Competency Assessment & Evaluation – Ensure employees meet qualification and performance standards.

✔ Training Expiry & Renewal Tracking – Set reminders for recertifications and refresher courses.

✔ Approval & Sign-Off Section – Assign responsibility for training validation and compliance verification.

✔ Editable Digital Format – Fully customizable for various training programs and job roles.

This ready-to-use training record template is ideal for HR teams, quality managers, and regulatory professionals, ensuring structured, traceable, and audit-ready training management.

Download the ISO 13485:2016 Training Record Template today and enhance your competency tracking and compliance system!