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ISO 13485 Quality Manual
Easy to use, ready to customize & includes FREE training!
Save
the time and resources required to design and document an ISO 13485 Quality
Management System. The 13485 Store has created most of it for you.
Begin with this fully documented 36 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?
NOTE: This manual covers both ISO 9001 AND ISO 13485.
ISO 9001 areas are highlighted for easy identification.
ISO 13485 Quality Manual includes:
- (1) FREE Online
ISO 13485 Training session! ( value)
 40 pages in 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
- An example process flow chart
- Required references to the recommended procedures for your quality
management system (Procedures & Forms sold separately or as part of a
package)
- Intuitive Architecture for easy Document
Control
- We've numbered the sections of the Quality Manual 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.
ISO 13485 Documentation Scheme
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. Why create your own? Upgrade to the Quality
Manual and Procedures packet and use ours.
How
much documentation do I need? View ISO 13485 Documentation Requirements
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.
This is a downloadable product and the training is taken via the internet.
You will also have the option of
purchasing the files on CD-Rom during checkout but it is not necessary.
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Includes 1 free 
