Quality management system (MU3))

From OpenEMR Project Wiki


OpenEMR adopted a quality management system (QMS) that follows the ISO 9001 standard's requirements to improve communication, transparency, performance and development for the overall project.


A QMS is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. Since ISO 9001 is the leading standard for QMS requirements and with the abundance of guides, books and blogs regarding it's use it was a natural selection for OpenEMR.

ISO 9001 is based on ISO 9000 which comprises the seven fundamental quality management principles that underlie a QMS. Although ISO 9001 certification would seem to belong to the domain of large organizations it can be beneficial to smaller entities like OpenEMR.

Configuration Management

Configuration Management (CM) is a systems engineering process for establishing and maintaining consistency of a product's performance, functional, and physical attributes with its requirements, design, and operational information throughout its life. OpenEMR's application of the ISO 9001 standard's requirements allows it to function as OpenEMR's CM.

Process Approach

OpenEMR uses a process approach for planning and management of interrelationships and interdependencies which incorporates the Plan-Do-Check-Act (PDCA) Cycle and risk-based thinking. It enables OpenEMR to achieve effective performance, add value and enhance customer satisfaction. For OpenEMR this means delivering working software in order to maintain it's status as the most popular open source electronic health records and medical practice management solution.

PDCA Cycle and Risk-based Thinking

OpenEMR gathers a variety of inputs to help direct and establish the objectives of the software. There is the community forum, weekly calls, monthly board meetings and other platforms like github, slack, telegram and signal to name some of the most common. In addition there are regulations and certifications that also aid to guide development. Risk based thinking practiced by the leadership of OpenEMR helps to narrow the focus and direct resources to the effort.

A great tool that is used for the QMS and CM is git versioning and the workflow that is embedded in the github repository system.