ISO 13485 (Clause 6.2) - Letter of Appointment Template

Establish clear roles and responsibilities within your Quality Management System (QMS) with our ISO 13485:2016 Clause 6.2 Letter of Appointment Template. This essential template is designed to ensure that individuals assigned to key positions, such as those responsible for training and competency, are properly appointed and aligned with ISO 13485:2016 requirements. The Letter of Appointment clearly defines the roles, duties, and expectations for the appointed individuals, ensuring a smooth process for competency management and regulatory compliance.

✔ Pre-Formatted Letter of Appointment Template – Covers key ISO 13485:2016 Clause 6.2 requirements.
✔ Clear Role Definition – Ensure specific responsibilities are outlined for appointed personnel.
✔ Competency and Training Requirements – Define specific qualifications, experience, and training needs for the role.
✔ Performance & Accountability Expectations – Clarify performance standards and accountability for the individual in the role.
✔ Sign-Off & Acknowledgment Section – Ensure formal acceptance and acknowledgment of responsibilities.
✔ Audit-Ready Documentation – Keep structured records for internal audits and compliance checks.
✔ Editable Digital Format – Fully customizable for different roles and industry needs.

This Letter of Appointment Template is ideal for HR teams, quality managers, and compliance officers, ensuring a compliant and structured approach to assigning and documenting roles.

Download the ISO 13485:2016 Letter of Appointment Template today to enhance your competency management and compliance strategy!