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Training Record - ISO 13485

Training Record - ISO 13485

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ISO 13485 2016 +A11 2021 

QMS.6.2.0.3 – QR – Training Record 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.

How does the QMS.6.2.0.3 – QR – Training Record help us achieve compliance with ISO 13485?

  • ISO 13485 states that the organization 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;
    • maintain appropriate records of education, training, skills and experience.
  • The Training Record is used to plan and maintain a record of staff members having read and understood specific training documents as described in QMS.6.2.0 – QP – Training & Qualifications Procedure.
  • When new versions of procedures are issued, the training record can be referenced to ensure all applicable employees have read the newest version of the document.
  • Along with QMS.6.2.0.2 – QR – Training Matrix and QMS.6.2.0.1 – QR – Employee Induction Template, this document will provide evidence to demonstrate compliance to the requirements of the standard.
  • You will also be able to ensure and provide evidence that your employees have achieved the required competence to fulfil their roles.

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 qmsregs@patientguard.com.

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