ISO 13485 Bundle | All templates for ISO 13485:2016

ISO 13485 Bundle | All templates for ISO 13485:2016

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ISO 13485:2016 QMS Template Bundle

Enhance your Quality Management System with our comprehensive ISO 13485:2016 QMS Template Bundle, expertly crafted by the professionals at Patient Guard. This bundle provides all the required document templates to demonstrate conformity to ISO 13485:2016, making it the perfect solution for companies starting a Quality Management System (QMS) from scratch.

Why Choose Our Template Bundle?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Complete Solution: Includes all necessary documents and forms, providing a one-stop solution for establishing a robust QMS.
  • 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.

What’s Included in the Bundle?

This comprehensive bundle includes templates for:

  • Quality Manual
  • Quality Policy
  • Quality Objectives
  • Quality Procedures (QP)
  • Forms for Quality Records (QR)

A full list of templates in the bundle:

  • Software Validation and Revalidation Procedure
  • Master Software List
  • Software Acceptance Testing Template
  • Medical Device File Template – IVDR (EU)
  • Medical Device File Template – MDR (EU)
  • Declaration of Conformity Template
  • GSPR Template IVDR
  • GSPR Template MDR
  • Risk Management Plan
  • Medical Device Risk Identification Analysis and Control
  • Medical Device Risk Evaluation and Risk Benefit
  • Medical Device PMS (Post Market Surveillance) Plan
  • Control of Documents Procedure
  • Change Control Log
  • Master Document List
  • Control of Records Procedure
  • Quality Policy Template
  • Quality Objectives Template
  • QMS Planning Procedure
  • Management Review Procedure
  • Management Review Meetings Agenda Template
  • Management Review Meetings Minutes Template
  • Training and Qualification Procedure
  • Employee Induction Template
  • Training Matrix Template
  • Training Record Template
  • Job Description Template
  • Infrastructure, Work Environment, and Contamination Control Procedure
  • Product Realization Planning Procedure
  • Risk Management Procedure
  • Strategic Risk Register Template
  • Customer Related Processes Procedure
  • Design and Development Procedure
  • Supplier Evaluation and Monitoring Procedure
  • Supplier Evaluation Form Template
  • Approved Supplier List Template
  • Purchasing Procedure
  • Receiving Goods Inspection Template
  • Device History Record Template
  • Requirements for the Cleanliness of Products Procedure
  • Requirements for Installation Activities Template
  • Requirements for Servicing Activities Template
  • Process Validation Procedure
  • Validation of Sterilization and Sterile Barrier Systems Procedure
  • Product Identification and Traceability Procedure
  • Control of Monitoring and Measuring Equipment Procedure
  • Feedback Procedure
  • Complaints Procedure
  • Complaints Database Template
  • Complaint Investigation Form
  • Reporting to Regulatory Authorities and Vigilance Procedure
  • Internal Audit Procedure
  • Internal Audit Schedule Template
  • Internal Audit Plan Template
  • Audit Report Template
  • Non-Conformance Procedure
  • Non-Conformance Report Log Template
  • Non-Conformance Report Template
  • Rework Procedure
  • Measurement and Analysis Procedure
  • Corrective and Preventive Action Procedure
  • CAPA Log
  • CAPA Report Form

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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