ISO 13485 Bundle | All templates for ISO 13485:2016 For Cheap

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 [email protected].

      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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      Our other templates:

      Visit QMSREGS.com for other templates that might be of interest.