ISO 13485 (Clause 6.2) - Employee Appraisal Form Template
ISO 13485 (Clause 6.2) - Employee Appraisal Form Template
Template Overview
Template Overview
Maintain compliance with ISO 13485:2016 Clause 6.2 – Human Resources by implementing a structured Employee Appraisal Process. This Employee Appraisal Form Template provides a standardized approach to evaluating employee performance, competency, and training needs, ensuring personnel involved in medical device manufacturing and quality management meet regulatory requirements.
Key Features
Key Features
✔ Pre-Formatted Appraisal Form – Covers key ISO 13485:2016 Clause 6.2 requirements.
✔ Employee Performance & Competency Assessment – Evaluate skills, knowledge, and job-specific requirements.
✔ Training & Development Needs Section – Identify skill gaps and future training plans.
✔ Regulatory Compliance & Quality Responsibilities – Ensure employees understand and adhere to quality management system (QMS) requirements.
✔ Goal-Setting & Performance Improvement Plan – Establish objectives for professional growth.
✔ Manager & Employee Feedback Sections – Promote open communication and alignment of expectations.
✔ Editable Digital Format – Fully customizable to suit different roles, departments, and organizational structures.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is essential for HR teams, quality managers, and department heads, ensuring ongoing competency, regulatory compliance, and continuous improvement within your workforce.
Download the ISO 13485:2016 Employee Appraisal Form Template today and enhance your employee performance management process!
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Additional information
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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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For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.