ISO 13485 (Clause 6.2) - Written Statement Of Employment
ISO 13485 (Clause 6.2) - Written Statement Of Employment
Template Overview
Template Overview
Support your organization’s compliance with ISO 13485:2016 Clause 6.2 by clearly defining employee roles, responsibilities, and expectations using our Written Statement of Employment Template. This professional, ready-to-use document outlines key terms and conditions of employment to ensure that all staff members understand their duties, competency requirements, and their role in maintaining the effectiveness of the Quality Management System (QMS).
Key Features
Key Features
✔ Pre-Formatted Employment Statement – Aligned with ISO 13485:2016 Clause 6.2 for defining employee expectations and qualifications.
✔ Key Terms of Employment – Includes job title, duties, qualifications, training requirements, working hours, and employment conditions.
✔ Competency & QMS Responsibilities – Clearly outlines how the role contributes to the quality objectives and QMS effectiveness.
✔ Acknowledgement Section – Includes employee sign-off to confirm understanding and agreement.
✔ Editable Digital Format – Fully customizable for different roles, departments, and business models.
✔ Audit-Ready Documentation – Maintains compliance-ready records for HR files and regulatory inspections.
Why choose a QMS Template?
Why choose a QMS Template?
This template is ideal for HR teams, quality managers, and regulatory professionals.
Download the ISO 13485:2016 Written Statement of Employment Template today and promote workforce clarity and compliance!
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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