The Critical Role of Document Control Software in ISO-9001 Compliance

Over a million companies are ISO-9001 certified. ISO-9001 is the worldwide standard for maintaining a Quality Management System (QMS). Document control software helps organizations meet these standards with greater ease and effectiveness.

Managing the documentation for ISO-9001 compliance is no small undertaking. In the very early days of ISO-9001, document control was accomplished with a typewriter and a three-ring binder. Today most ISO documents are managed electronically on a shared network drive.  This is infinitely better than a paper process, but there are three major limitations of using network drives to manage ISO documents:

1. Controlling Versions
   A shared network drive is unable to tell you which version of a document is the latest, and fails to track the changes made to a document over time.
2. Workflow Automation
   Shared network drives simply store your files. There is no intelligence built-in to automatically route documents, mark them as approved, and make them available to the appropriate users.
3. Audit Trails
   For ISO-9001 compliance, it is important to know who has edited and accessed files and the actions taken on files throughout their lifecycle. Shared network drives do not have these capabilities.

This is where document control software steps in. Document control solves these problems by enforcing consistency and accountability across all documents in the system. It streamlines processes and helps to ensure that only authorized users can create, edit, review, and approve controlled documents.

The Importance of Document Control Software

To become ISO-9001 certified, an organization must demonstrate to an independent auditor the capabilities of their processes and prove the effectiveness of their quality management system. Document control software helps to achieve this with the following:

• Role-based security
  It is important to control who can access and make changes to files in the system. With role-based security, users (individually or in groups) are granted appropriate privileges for file access and editing capabilities. For example, roles can be created for users who need to make changes to a document, while other users are granted the ability to approve or simply view that document. This can be applied not only to individual documents, but entire folder structures as well.
• Security
  Security is vital in any system, and this is especially true for systems that maintain ISO-9001 compliance. Document control software can help to ensure only the appropriate users can access, edit, add, and remove files from the system. It also allows you to determine which users have accessed and modified files in the past.
• Folder management
  It is often the case that folders in the system have their own set of rules and requirements based on the files and sub-folders they contain. This is where folder management is helpful. Not only can it help to control access and privileges, but it can also control how documents are created and managed within that folder environment. For example, a specific folder may require certain naming conventions or templates to be automatically applied to newly created documents. Certain metadata values may also need to be applied as files are created or imported into the folder. Finally, files created or imported into the folder may automatically be routed through predetermined workflow processes.
• Template management
  Making changes to document templates can be troublesome because it’s difficult to ensure all users are applying the latest version of the template. Document control software can solve this problem by automatically applying the latest version of a template to the appropriate documents.
• Version control
  It is important to be able to track changes to a document over time. Version control in document control software automatically creates new versions of a file every time changes are made. This provides a complete history of the document and allows users to revert to prior version if necessary.
• Audit trail
  For ISO-9001 compliance, it’s important to maintain a complete record of changes and actions that take place on a file. Document control software maintains a detailed log for each document and tracks all the events that have occurred.
• Automated Workflows
  ISO-9001 compliance can be cumbersome and prone to errors if done manually on a shared file server. Document control software with electronic workflow dramatically improves efficiency and ensures that each workflow step is performed in the correct sequence by authorized users. Here are some examples of document control workflows for ISO-9001 compliance:
  • • Change Requests and Corrective Actions: Workflow automates a request for change and the documentation needed to state the reason and impact of the change.
    • Reviews: Workflow automates the document review processes and assigns reviewers of a document.
    • Approvals: Workflow ensures that all reviewers are in agreement via electronic approvals and automatically sends notifications to users upon approval.
    • Publishing: Workflow automatically creates final versions of approved documents and makes them available to those with access.

• Required Reading
  When important files are updated or added to the system, such as policies and procedures, it can be difficult to ensure that everyone is informed of these changes. Document control software with “required reading” capabilities sends notifications to the appropriate users informing them of changes and requiring them to read specific documents. The users must then confirm they have read the information, ensuring that all relevant users are informed of changes.
• Searching
  With so many folders and files in the system, finding the document you need quickly can be time consuming in a manual, shared server environment. Document control software with built in search capabilities can significantly reduce the time it takes to find documents.
• Reporting
  Document control software with reporting capabilities provides authorized users with a quick overview of what documents are in the system and how they are being accessed and used. This provides a high level of understanding of how the system is functioning and gives insight into improvements that can be made.
  

What to look for in a Document Control Software System for ISO-9001 Compliance

Here some questions to ask when selecting document control software include:

1. How easy is it to search for documents and navigate the software?
2. How easy is it to import files (both paper and electronic) into the system and organize them in a meaningful way?
3. Does the system support all your required document types such as PDF files, Office documents, various image file types, and XML files?
4. Does the software support document control tasks such as checking out files, version control, workflow automation, reporting tools, and digital signatures?

Getting Started with ISO-9001 and Document Control

Document control software sets the foundation for a successful ISO-9001 quality program. The ability to quickly access and manage digital documents that are located in a centralized, secure location provides a great advantage to enforce consistency and accountability.

While selecting the right document control software can be a challenging endeavor, it is an important part of creating an effective ISO-9001 compliant quality management system.

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