Check List for ISO 13485:2016

Check List for ISO 13485:2016

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ISO 13485:2016 QMS Template - Checklist

Enhance your Quality Management System with our ISO 13485:2016 compliant checklist, expertly crafted by the professionals at Patient Guard. Experienced experts develop our Quality Assurance and Regulatory Affairs document templates, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Seasoned Quality Assurance and Regulatory Affairs specialists created our templates, ensuring 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: Our template helps you maintain a comprehensive checklist, demonstrating effective document control as required by ISO 13485:2016.

Why Do You Need an ISO 13485 Checklist?

This comprehensive ISO 13485:2016 Quality Management System checklist allows you to:

  • Identify Applicable Clauses: Determine which clauses are relevant to your medical device(s) and document your reasoning.
  • Document Evidence: Record evidence to demonstrate compliance with each applicable clause.
  • Quickly Assess Compliance: Gain a clear, overarching view to quickly identify if you meet the requirements for your medical device Quality Management System.
  • Facilitate Audits: Ensure you meet all applicable clauses of the standard, which is particularly useful during audits by Notified Bodies or Certification bodies.

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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