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ISO 13485:2003 or ISO 13485:2016 Quality Manual

 » Easy to use, ready to customize & includes FREE training!

All In One Package


"Anytime you need to use my name for your products and service I will give you an E for excellent on products and an A+ for outstanding service."

- Bettye Patrick, United Plating

Available in two formats: 2016 Version and prior Version (see compare)


Save the time and resources required to design and document an ISO 13485 Quality Management System. ISO 13485 Store has created most of it for you. The key to an effective Quality Management System is designing the documentation for efficiency and ease of use. Our documents, edited by professional technical writers, have been written in Microsoft Word so you can easily edit and customize them to make them your own. When you have questions, our experts are only an email away.

Begin with this fully documented 40 page ISO 13485 Quality Manual that has been used for successful registrations across the globe. You will appreciate its ease of use - simple yet thorough. Why make it complicated?


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See how a QMS Works!

  • MS Word format for ease of editing
  • Text to address each requirement of the ISO 13485 Standard
  • Very clear instructions in obvious Blue Text to show you where to customize your Manual
  • Required references to the recommended procedures for your quality management system
  • Logical document numbering for easy Document Control
    • We've numbered the sections of the Quality Manual to correspond with the sections of the ISO 13485 Standard. Registrars LOVE this feature!
    • Procedure and Form numbers relate to the section in the Quality Manual.
  • This is a downloadable product and the training is taken via the internet.
    • You will also have the option of purchasing the files on Jump Drive during checkout but it is not necessary.
  • The online training session is approximately 30 minutes, includes audio, quizzes, and will give you an overview of the importance of ISO 13485 and your role in meeting the requirements.



View Sample2003 Quality Manual

View Sample2016 Quality Manual

View Training Agenda2003 Online Training Agenda

  • Includes Technical Support
  • 1 Free Online Training Session (only available with the 2003 Version)
  • Quality Manual
  • Sample Flow Chart

According to the ISO 13485 Standard: the Quality Manual needs to refer to the processes which make up The Quality Management System (QMS). Our Quality Manual already references our procedures and forms, saving you much time and money. You will need to add procedures and forms to your QMS. Why create your own? Upgrade to the Quality Manual and Procedures package and use ours.

ISO 13485 Documentation Scheme

ISO 13485 Documentation Scheme

ISO 13485 Documentation Requirements

Compare Products

13485:2003 to
2016 QMS
13485:2003 to
2016 QMS
Technical Support ✓ ✓ ✓ ✓ ✓ ✓
2003 to 2016 Upgrade Instructions     ✓     ✓
Quality Manual ✓ ✓   ✓ ✓  
Procedures       ✓ ✓ ✓
Forms       ✓ ✓ ✓
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