Employee Induction - ISO 13485

Streamline your employee onboarding process and ensure regulatory compliance with our ISO 13485:2016 Clause 6.2 Employee Induction Template. Proper induction and training are essential for ensuring that new employees in medical device manufacturing, quality management, and regulatory roles are familiar with company policies, quality requirements, and compliance obligations. This structured induction template provides a clear and organized framework to ensure all necessary topics are covered, supporting compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Employee Induction Checklist – Covers key ISO 13485:2016 Clause 6.2 requirements.

✔ Company Policies & Quality Management System (QMS) Overview – Introduce employees to ISO 13485 requirements and responsibilities.

✔ Regulatory & Compliance Training Sections – Ensure employees understand safety, quality, and regulatory obligations.

✔ Job-Specific Training & Role Expectations – Align training with job responsibilities and competency requirements.

✔ Health & Safety, Risk Management & Data Protection – Cover critical workplace safety and compliance areas.

✔ Sign-Off & Acknowledgment Section – Maintain audit-ready records of employee onboarding.

✔ Editable Digital Format – Fully customizable for different roles and business needs.

This ready-to-use induction template is ideal for HR teams, quality managers, and regulatory professionals, ensuring a structured, compliant, and effective onboarding process.

Download the ISO 13485:2016 Employee Induction Template today and enhance your training and compliance system!