ISO 13485:2016 Quality Manual and Procedures

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All the Documentation you need

Created in MS Word for easy editing

Uses Logical Document Numbering Scheme

Easy to customize for your organization

The manual references related procedures


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See how a QMS Works!

  • 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

Product Details

Product Type: Digital

Price: $397.00

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ISO 13485:2016
QMS Package
ISO 13485:2003
to 2016
QMS Upgrade
ISO 13485:2003
to 2016 QMS
ISO 13485:2016
Technical Support N N N N
Quality Manual N N N
ISO 13485:2016 QMS Upgrade Instructions N N
ISO 9001 to ISO 13485:2016 QMS Upgrade Instructions
Procedures 26 6 26 27
Forms & Attachments 47 5 47 44


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Order Now!


Order Now!


Order Now!