ISO 13485 Complete System Software Package

Since 1992, AQA's ISO systems have been implemented and certified in thousands of companies

The Complete System includes:

Paperless Document Control (SW)
Automated ISO Management (SW)
Template Manual & Procedures
Internal Audit Checklist
Employee Training Booklets
Tutorials and Guides (PDF)

	Download Free Trial
	Quick Tour Slide Show

Download Quick Tour PDF

Bundle of 4 products

To learn more about each of the 4 products included in this bundle click the appropriate icon or link below.


	ISOXpress — ISO 13485 Document Control and Quality System Software (10 modules)

	ISO 13485:2003 Quality Manual, Procedures and Forms

	ISO 13485:2003 & 21 CFR 820 Internal Audit & Gap Analysis Checklist

	ISO 13485 Our Company, Self-Study Course for Personnel (10 PDF booklets)

Also fully complies with
21 CRF 820 (FDA QSR)

ISO 13485
COMPLETE SYSTEM
SOFTWARE PACKAGE

Bundle of Four Products Integrated
Into a Software-driven System

Single Computer
Installation

Purchase

5-Users Network
Installation

Purchase

Quick Tour Slide Show and Trial Software

After you have read the information on this page, you can get a better feel of the software by viewing the Quick Tour Slide Show, or downloading and playing with a 30-day Free Trial Software.

Everything You Need to Jump-start Your ISO 13485 Project

As soon as you install the software most of your new quality system is automatically implemented. You can immediately start editing and controlling your documents, initiate corrective actions, process customer complaints, and so forth. The only work left is to customize the manual, procedures and forms, and start running the system.

Platform for Paperless Management of Your Quality System

After you implement your ISO 13485 system, the ISOXpress software will continue serving you as a platform for paperless document control and day-to-day managing of the quality system.

There is Plenty of Help

This software package can be easily implemented without any prior experience with ISO 13485 quality systems. Everything you need to learn and know is included in the package:

The ISOXpress software Help consists of tutorials (slide shows) showing how everything is done. For example, how to establish new users and assign permissions, how to manage and control documents, how to plan and monitor internal audit cycle, how to customize reports, and so forth.
The Template Manual and Procedures have plenty of embedded tips and notes to help you edit and customize the documents to fit your company. It is like having a consultant by your side, anticipating your questions and helping as you go along.
The Internal Audit and Gap Analysis Checklist includes an integrated auditing tutorial — an additional column, "What to look for and how", with tips and instructions for the auditor.
The Employee Training Booklets provide basic information and an overview of how the ISO 13485 quality system works.

ISO 14971
Risk Management
Software

Quick FAQs

Are the template manual and procedures pre-loaded into ISOXpress?
Yes. In the Complete System Package the ISO 13485 Template Documentation and ISO 13485 & 21 CFR 820 Internal Audit Checklist are pre-loaded into the ISOXpress software.
What are the system requirements for the ISOXpress software?
The server can be any computer on your network. It only needs to host a file folder, so there are really no system requirements.

The requirements for client computers are:
- Windows 2000 or higher
- Memory 250 MB or higher
- Adobe Reader (free PDF Reader)
What document file formats are supported?
You can create your documents in any file format (MS Word, Excel, PowerPoint, Visio, CAD, anything...) and then convert them to PDF files before importing into the ISOXpress system.

There is also an integrated MS Word-like editor that automatically handles the PDF conversion and manages the master (.doc) files.
Can I return the Complete Package and get my money back?
Yes, you can return the software, but not the other items. More details in our 30-day Money Back Return Guarantee.


Products	Support	Customer Support		Other Systems
Complete Package	Downloads	Satisfied Customers	Purchase Orders	ISO 9001
ISOXpress Software	Support Center	Return Guarantee	International Orders	ISO 14001
Template Documentation	Support Request	Support Policy	About AQA Co.	ISO 9001+14001
Internal Audit Checklist		Privacy Policy	Contact AQA Co.	ISO 13485
Employee Training				ISO 14971

Sitemap