Complete ISO 13485 System Software:

Manual, Procedures, Training Materials, Audit Checklist, Risk Management...
Since 1992, AQA's ISO systems have been implemented and certified in thousands of companies
Featured Product
  • Document Control
  • ISO Management Modules
  • Template Manual & Procedures
  • Internal Audit Checklist
  • Employee Training Booklets
  • Tutorials and Guides (PDF)
All ISO 13485 products also fully comply with
21 CFR Part 820 (FDA Quality System Requirements)
Complete ISO 13485
System Software Package
Get all four products (below) bundled into a complete system, and save $580.
More Information UNO $1,490 NET $1,990
ISO 13485 Document Control
and Quality System Software
Software for paperless management of an ISO 13485 quality system, including 10 modules:
- Document Menu
- Document Control
- CAPA
- Internal Audits
- Training
- Management Reviews
- Supplier Control
- Nonconforming Products
- Customer Complaints
- Measuring Equipment
More Information UNO $990 NET $1,490
ISO 13485:2003 Template
Quality Manual, Procedures and Forms
This template documentation can be purchased in two versions:
  • As a set of 55 MS Word files ($890); or
  • Pre-loaded into the ISOXpress software (available only in Complete System Package).
More Information Purchase $890
ISO 13485:2003 and
FDA QSR (21 CFR 820)
Internal Audit & Gap Analysis Checklist
30-page MS Word checklist. Includes built-in tutorial for training auditors.
More Information Purchase $39
ISO 13485 In Our Company
Self-Study Course for Personnel
24-page training booklet, test, and certificate
PDF Files with license for 10 trainees
More Information Purchase $49
Quick FAQs
  • What makes this system especially affordable and easy to implement?
  • We are a small company. Why should we need a paperless, computer-based system?
  • Can I implement this system by myself without a consultant? What kind of instructions, help and tutorials are available?
  • What do I need to do to customize the system to fit my company?
  • Do you offer training for using the software?
  • Is phone support available?
  • What are the minimum system requirements to run the ISOXpress software?