ISO 13485:2016 Quality Manual

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


Created in MS Word for easy editing

Uses Logical Document Numbering Scheme

Easy to customize for your organization

The manual references related procedures

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?

  • 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 Tutorial

See how a QMS Works!

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

Product Details

Product Type: Digital

Price: $97.00

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