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Job Description Template - ISO 13485

Job Description Template - ISO 13485

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ISO 13485:2016 QMS Template - Job Description (QMS. – QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Job Description template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain effective job description procedures, demonstrating robust quality management as required by ISO 13485:2016.

What Does ISO 13485 Say About Providing Job Descriptions?

The ISO 13485 standard requires organizations to:

  • Ensure Competence: Personnel performing work affecting product quality must be competent based on appropriate education, training, skills, and experience.
  • Determine Competence: Identify the necessary competence for personnel performing work affecting product quality.
  • Raise Awareness: Ensure personnel understand the relevance and importance of their activities and how they contribute to achieving quality objectives.
  • Maintain Records: Keep appropriate records of education, training, skills, and experience.

How Will the Job Description Template Help My Organisation Achieve Compliance?

The Job Description Template (QMS. – QR) helps your organization:

  • Define Roles: Determine and set essential duties and responsibilities for each job role.
  • Specify Competencies: Outline required competencies, qualifications, and other criteria for job roles.
  • Demonstrate Compliance: When filled out by an employer and agreed to by an employee, the template shows compliance with ISO 13485 requirements.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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