Job Description Template - ISO 13485
Job Description Template - ISO 13485
Template Overview
Template Overview
Ensure clear role definitions and competency management with our ISO 13485:2016 Clause 6.2 Job Description Template. Properly documented job descriptions are essential for ensuring personnel competency, regulatory compliance, and quality management in medical device manufacturing. This structured template helps organizations define roles, responsibilities, and required qualifications in alignment with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820 requirements.
Key Features
Key Features
✔ Pre-Formatted Job Description Template – Covers key ISO 13485:2016 Clause 6.2 requirements.
✔ Role & Responsibilities Section – Clearly define duties and expectations for each job position.
✔ Required Qualifications & Competency Criteria – Ensure employees meet regulatory and operational needs.
✔ Training & Development Needs – Identify necessary skills, certifications, and ongoing training.
✔ Reporting Structure & Accountability – Define who the employee reports to and interacts with.
✔ Regulatory & Quality System Responsibilities – Align with QMS, risk management, and compliance obligations.
✔ Editable Digital Format – Fully customizable for various roles within medical device organizations.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use job description template is ideal for HR teams, quality managers, and regulatory professionals, ensuring structured, compliant, and well-defined role management.
Download the ISO 13485:2016 Job Description Template today and strengthen your competency framework and regulatory compliance!
Couldn't load pickup availability
Share
Additional information
-
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.
-
Secure Payment and Document Download
Our secure system keeps your transaction safe, and the email will be sent promptly to the address you provided. Just click the link to instantly access and download your documents.
-
Contact Us
For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.