ISO Document Control


MasterControl Has An ISO Document Control Software Solution That Makes Meeting ISO Requirements Easier

The concept of document control is integral to ISO 9000. ISO 9001 2000, for example, requires the establishment of a document control software system that stores and manages documents relating to the implementation, maintenance, and continuous improvement of a quality management system.


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Here's how MasterControl Documents meets all the requirements of ISO document control:


Document Control Challenges

MasterControl Documents Solution




Inefficient Paper-based Document Control System


Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid document control systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during ISO audits.


Efficient Document Control System

MasterControl meets the requirements of ISO document control by automating the routing and delivery of SOPs, policies, and other documentation. The document control software from MasterControl can handle all types of documents regardless of the software used to create them. It provides a secure and centralized repository for document control that makes search and retrieval easy during inspections and audits. And, because it is Web-based, MasterControl Documents is accessible to all authorized users from virtually anywhere.



Lack of Document Revision Control


In a paper-based system or hybrid system, employees check out documents and other materials (engineering drawings, etc.) manually. Tracking down any document activity is difficult. Making a change in an SOP or other document requires manual submission of a change request or discussion of the change in face-to-face meetings.

Automated Document Revision Control


MasterControl meets the requirements of ISO document control by providing automatic revision control to ensure that only the current version of a document is available. Changes are initiated and approved electronically. When a user makes a change, he or she must enter the reason in the InfoCard (the MasterControl tool that provides basic information for every record). The system tracks all changes and makes them available through reports.



Disconnected Document Control Processes


Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. Ineffective communication can lead to delays and poor results.

Integrates Training with Document Control Processes


The software for document control management from MasterControl meets all requirements of ISO document control by connecting to all quality sub-systems like CAPA, change management, audit, customer complaints, employee training, etc.



Lack of Oversight


It's difficult to generate accurate and timely reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders). Without an effective reporting tool, managers are unable to get control of their quality management system.

Increased Management Visibility


MasterControl meets the requirements of ISO document control by providing an advanced analytics and reporting capability, including customizable reports and online charting. Through these reports, managers get a real-time view of the quality processes, and can be more proactive about improving their quality system.



MasterControl Meets All Requirements of ISO Document Control


  • Combines powerful electronic routing and approval
  • Full audit trail and reporting
  • Electronic signature management and control
  • Ensures ISO 9000 compliance with security and integrity of documents
  • Scalable, open systems architecture
  • Supports industry-standard databases

For More Information

To learn more about ISO Document Control, as well as electronic document control and other solutions from MasterControl, please contact a MasterControl representative.