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Training and Qualification Procedure - ISO 13485

Training and Qualification Procedure - ISO 13485

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ISO 13485 2016 + A11 2021 

QMS.6.2.0 – QP – Training & Qualification Procedure 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 is the Training and Qualifications Procedure for?

  • The Training & Qualifications Procedure helps your organisation identify, plan, document and control training processes.
  • You will then use these processes to ensure employees are appropriately qualified for their job functions.
  • This procedure can be applied to anyone at your company who performs work, including full-time employees, fixed assignment employees, part-time employees, or contractors.

How will this procedure help my company comply with ISO 13485?

  • ISO 13485 requires that organisations shall:
    • determine the necessary competence for personnel performing work affecting product quality;
    • provide training or take other actions to achieve or maintain the necessary competence;
  • The template will aid your organisation in meeting the above requirements as well as provide supporting evidence for other parts of the standard.

How else will the procedure benefit my organisation?

  • You will be able to ensure and provide evidence that your employees are well qualified for their positions.
  • You will be able to standardise the process through which new employees are inducted/onboarded and ensure that they are well equipped for and capable of carrying out their duties.

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

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.

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