Change Management in Enterprise Quality Management System

Change Management Software

Change Management within the Enterprise Quality Management System (QMS) refers to the structured approach of transitioning individuals, teams, and organizations from a current state to a desired future state. It is a critical aspect of QMS because it ensures that changes to processes, products, or systems are implemented in a controlled and systematic manner, thereby maintaining the integrity of the quality management process. This approach minimizes risks and maximizes the benefits of change, ensuring continuous improvement and compliance with regulatory requirements. Several standards emphasize the importance of managing change as part of ensuring quality, safety, environmental management, and information security.

Change Management Software is compliant with the following standards:

  • ISO 9001:2015
  • ISO 14001:2015
  • ISO 45001:2018
  • ISO 27001:2013
  • ISO 13485:2016
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Features and Benefits (Change Management Software)

Change Management

  • Manage critical changes in the Product Life Cycle through a seamless change management process, eliminating disconnects in the changes.

Automated Workflows

  • Automates the process of initiating, approving, implementing, and reviewing changes, ensuring that all steps are completed in a consistent and timely manner.

Stakeholder Communication

  • Facilitates effective communication with stakeholders throughout the change process, ensuring that everyone is informed and aligned.

Version Control

  • Change management integrates with document control (Document Pro) to control revisions of the changes, ensuring that users can access the latest version.

Risk Assessment Tools

  • Integrates risk assessment tools to help in identifying and evaluating the potential impacts of changes, enabling more informed decision-making.


  • Seamlessly integrates with other components of the QMS, such as non-conformance reporting, CAPA (Corrective and Preventive Actions), Inspections, New Product Development (NPD) or APQP, Supplier Deviation Request.

Configurable Change Form

  • Change management software allows categorization of different types of changes and enables the creation of change management forms tailored to the organization's needs.
Change Management Software

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