ISO 13485 Quality Manual & Procedures Package

Includes a fully-customizable (MS Word) ISO 13485 Quality Manual, complete set of 26 QMS Procedures and 30 related forms all connected with a logical numbering system for easy document control.

File Size: 3.54 MB
Format: Word/Excel
Language: English
Product Type: Manual
Provider: 13485 Store

Price: $397.00
Product Details


  • Provides the processes and documents needed to design and build an ISO 13485 compliant Quality Management System.
  • Includes text to address each requirement of the ISO 13485 Standard.
  • Document numbering system ensures solid Document Control.
  • Master Document List is completed and ready for Work Instructions.
  • All documents are written in MS Word or Excel for ease of use and editing.


  • 40 page customizable ISO 13485 Quality Manual
  • (26) Quality System Procedures
  • (41) related Forms

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