ISO 13485 All in One Documentation & Training Package

The 13485 All In One Package includes everything needed to prepare for certification: Manual, Procedures & Forms, Checklists, Employee & Internal Auditor Training. Includes support!

File Size: 14.9 MB
Format: Word/Excel/PPT
Language: English
Product Type: Package
Provider: 13485 Store

Price: $997.00
Product Details


  • Includes all the tools and documentation needed to prepare for ISO 13485 registration.
  • Ideal for organizations or consultants who need a proven, efficient set of sequential processes, with all the necessary documentation and training elements in place to create a Quality Management System.
  • The Quality Manual and Procedures are fully integrated, related forms are included, and the Master Document List is completed and ready for Work Instructions.
    • Includes text to address each requirement of the ISO 13485 standard.
    • Intuitive numbering system for easy Document Control.
  • Documents are written in MS Word and Excel for ease of use and customization.


  • 61 page Intro to ISO 13485 PowerPoint Presentation Materials
  • 40 page ISO 13485 Gap Checklist
  • 40 page customizable ISO 13485 Quality Manual
  • (26) Quality System Procedures
  • (41) related Forms (MS Word and Excel)
  • ISO 13485 Internal Audit Checklist and Forms
  • ISO 13485 Internal Auditor Training Materials
  • ISO 13485 Employee Training (50 sessions)
  • (11) Customizable Employee Newsletters
  • Risk Management Guide

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