ISO 13485:2016 Quality Manual and Procedures

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$397.00

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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Which version is right for me?

Choose ISO 13485:2016 to create a new ISO 13485 Quality Management System

Choose ISO 13485:2003 to 2016 QMS Upgrade to modify your existing ISO 13485:2003 QMS to meet the ISO 13485:2016 requirements

Choose ISO 13485:2003 to 2016 QMS to modify your existing ISO 13485:2003 QMS to meet the ISO 13485:2016 requirements

If you plan to reconfigure your existing quality manual and procedures to meet the ISO 13485:2016 standard, use Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide templates or new verbiage on the new requirements.

ISO 13485:2016
QMS Package
ISO 13485:2003
to 2016
QMS Upgrade
ISO 13485:2003
to 2016 QMS
ISO 13485:2016
FDA QMS
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 26 27
Forms & Attachments 47 47 44

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