Software ISO for 13485 ISO 14971 management system

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ISO 13485/ISO 14971 certification program

If you are looking for a reliable, easy-to-use, affordable and efficient software that should help in developing, implementing and maintaining the Quality and Risk Management System in accordance with ISO 13485:2003 and ISO 14971:2007 requirements), lean back and relax - you have just found it! "ISOsystemPlus-ISOMED" is the software!

"ISOsystemPlus-ISO-MED" consists of several modules which address various aspects of management systems (and you could select only those modules which your company's management system really needs):
  1. "Documents" - document control/management system.
  2. "Risks" - risk analysis/management system per ISO 14971 requirememts;
  3. "Processes" - implementation of "process approach" requirement.
  4. "Trainings" - personnel training/competence development.
  5. "Audits" - audits/corrective/preventive actions.
  6. "Equipment" - control/management of organization's equipment.
  7. "Complaints"" - handling with/management of customer complaints/requests.
  8. "Non-conformities" - registration/control of non-conformities, comparative analysis of non-conformities, quantitative evaluation of effectiveness of functioning of the Management System, graphical (charts) representation of the results of analysis.

You can customize your configuration of the applicationand select only those modules which are really needed for your company's management system, thus determining the price of the software for your company.

Please note! Having purchased even one module, you get:

  • Unlimited number of user working stations which can be linked to the server database file
  • Built-in CRM-mode "Counterparties", which will make users capable in effective managing the contacts with external stakeholders (suppliers, customers, etc.)
  • "Internal mail" - tool for communication between the application's users in the real-time mode (no need in Internet access/e-mail agent)
  • Free longlife update with the new versions.
  • Free longlife technical support from the company - application's developer

Along with the modules mentioned above, ISOsystemPlus features advanced capabilities, such as:

  • Two versions of the application:

  •         - Local network version
            - WEB-version.
  • internal communications tools;
  • built-in editors of process diagrams (flow-charts);
  • tools for quantitative evalutaion of effecetiveness of the Management System;
  • tools to keep customer and supplier registers, etc., etc.
  • Multilingual interface. The following* language versions are available:

     Chinese  Español  Portuguese  Française  Deutsch  Italiano  Polska  Russian  Dutch  Bulgarian  Indonesian  Turkish  Romanian  Croatian  Chekh  Portuguese  Hungarian  Latvian  Lithuanian  Bosnian

     Serbian  Makedonian  Ukrainian  Hebrew  Greek


        *Interfaces in Hebrew and Arabic are being designed now.
        *If an interface language which you need is missing in the list please let us know about it and we will add the language.

Even the most demanding users will be pleasantly surprised by the ISOsystemPlus.

Is it interesting to you? We hope - yes. So now you can: