Quality management system (MU3))

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Overview

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.

Background

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 as explained below.

Process Approach

Plan-Do-Check-Adjust Cycle

Risk-based Thinking