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Training Record Template - ISO 13485

Training Record Template - ISO 13485

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ISO 13485:2016 QMS Template - Training Record (QMS. – QR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Training Record 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 training records, demonstrating robust quality management as required by ISO 13485:2016.

What is a Training Record?

A Training Record is used to plan and maintain a record of staff members having read and understood specific training documents. It ensures that all personnel are appropriately qualified for their job functions and that they have achieved the necessary competence to fulfil their roles.

How Does the Training Record Fit Into the QMS?

The Training Record forms part of your evidence demonstrating your compliance with clause 6.2 of ISO 13485, along with other documents such as:

The Training & Qualifications Procedure The Training Matrix The Employee Induction Template This template ensures that your training records are accurate, up-to-date, and relevant to your organisation’s needs.

How Will Having a Training Record Help My Organisation?

The Training Record template helps your organization:

Plan and Document Training: Record training sessions and ensure staff members have read and understood specific training documents. Maintain Compliance: Ensure compliance with ISO 13485 by maintaining appropriate records of education, training, skills, and experience. Track Competence: Provide evidence that your employees have achieved the required competence to fulfil their roles.

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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