Training and Qualification Procedure - ISO 13485

Ensure employee competency, regulatory compliance, and continuous improvement with our ISO 13485:2016 Clause 6.2 Training & Qualification Procedure Template. Proper training and qualification of personnel involved in medical device manufacturing, quality management, and regulatory processes is essential for ensuring product safety, compliance, and operational efficiency. This structured procedure template provides a systematic approach for planning, conducting, and documenting employee training, ensuring alignment with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Training & Qualification Procedure – Covers key ISO 13485:2016 Clause 6.2 requirements.

✔ Employee Training & Competency Evaluation Framework – Ensure personnel meet regulatory and operational needs.

✔ Job Role-Specific Training Plans – Define required skills, certifications, and ongoing development.

✔ Training Records & Qualification Tracking – Maintain audit-ready documentation of training activities.

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

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

✔ Risk-Based Approach & CAPA Integration – Ensure training addresses quality and compliance risks.

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

This ready-to-use training and qualification procedure template is ideal for HR teams, quality managers, and regulatory professionals, ensuring a structured, compliant, and efficient employee training system.

Download the ISO 13485:2016 Training & Qualification Procedure Template today and enhance your workforce competency and compliance strategy!