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Job Description - ISO 13485

Job Description - ISO 13485

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ISO 13485 2016 +A11 2021

QMS. – QR – Job Description Template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

What does ISO 13485 say about providing job descriptions?

  • The ISO 13485 standard requires that organisations shall:
    • ensure personnel performing work affecting product quality be competent on the basis of appropriate education, training, skills and experience;
    • determine the necessary competence for personnel performing work affecting product quality;
    • ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;
    • maintain appropriate records of education, training, skills and experience.

How will the QMS. – QR – Job Description Template help my organisation achieve compliance with ISO 13485?

  • – QR – Job Description Template will allow you to determine and set essential duties and responsibilities, required competencies and qualifications and other details and criteria for any given job role within your organisation.
  • When filled in by an employer and read, understood and agreed to by an employee, the completed template will demonstrate compliance with the above requirements of the standard.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at

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