ISO 13485:2016 Quality Manual and Procedures

Save Time, Save Money, and Simplify Certification with the RIGHT QMS!


  • Quality Manual in MS Word format for ease of editing
  • Procedures are written in MS Word and are ready for your customization
  • Related Forms are written in MS Word or Excel
  • Text to address each requirement of the ISO 13485:2016 Standard
  • Very clear instructions in obvious Blue Text to show you where to customize your Manual and Procedures
  • Required references to the recommended procedures and forms for your quality management system
  • Intuitive architecture for easy Document Control
    • We’ve numbered the sections of the Quality Manual to correspond with the sections of the ISO 13485:2016 Standard. Registrars LOVE this feature!
    • Procedure and Form numbers relate to the section in the Quality Manual.
  • This is a downloadable product.
    • You will also have the option of purchasing the files on a Jump-Drive during checkout but it is not necessary.
  • Includes Technical Support
  • Quality Policy Template & Sample
  • Quality Manual
  • Procedures
  • Forms referenced by the Quality Manual and Procedures
  • 3 Templates to create additional Procedures, Forms and Work Instructions

13485:2016 QMS Procedures and Forms Matrix

Product Details

Product Type: Digital

Price: $397.00

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Which version is right for me?
  • Choose 13485:2016 to create a new 13485 Quality Management System
  • Choose 13485:2003 to 13485:2016 QMS instructions to modify your existing 13485 QMS to meet the 13485:2016 requirements
  • Choose 13485:2016 FDA QMS Upgrade to develop an integrated management system that is 13485 and FDA.QSR (21 CFR 820) compliant as of April 2016 (this is the reference date of the CFR)
  • Choose ISO 9001:2015 / 13485:2016 QMS to align ISO 13485:2016 (8 section format) with ISO 9001:2015 (10-Section Annex SL Format).
    • This QMS is for organizations (like Contract Manufacturers) who want ONE QMS for both ISO 9001:2015 and ISO 13485:2016.
    • Quality Management System Templates covering both the ISO 9001:2015 (Annex SL 10-section format) and ISO 13485:2016 (8-Section format) in ONE combined, Annex SL manual.

If you plan to reconfigure your existing quality manual completely by yourself, you can use either of the Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide any procedure or form templates for the new requirements.


  Price Each 13485:2003 to 13485:2016 QMS Instructions 13485:2003 to 13485:2016 QMS Package 13485:2016 QMS 13485:2016 QMS with FDA 13485:2016 / 9001:2015 Combined QMS
Your Price  
ISO 13485:2016 Quality Manual (not sold separately) $97.00     N N  
ISO 13485:2003 to 2016 Upgrade Instructions $199.00 N N      
ISO 13485:2016 to FDA Upgrade Instructions $199.00          
ISO 13485:2016 / 9001:2015 Combined QMS $497.00         N
ISO 13485:2016 Procedures $300.00   26 26 27 24
ISO 13485:2016 Forms $100.00   48 48 48 55
ISO 13485:2016 Flow Charts $75.00   23 23    
Support FREE N N N N N
Your Price