Key System Terms in ISO 9000:2015 – Quality Management System Explained

In this video, we discuss essential system-related terms from ISO 9000:2015, highlighting how these elements work together to create a robust Quality Management System (QMS). These terms are critical for understanding how organizations can effectively manage and improve their quality processes.

Let’s explore these key terms:

System:
A system refers to a set of interrelated elements working together to achieve specific objectives. In the context of a QMS, the system includes processes, resources, and procedures necessary to meet quality standards and satisfy customer requirements.

Infrastructure:
Infrastructure encompasses the physical resources, facilities, technology, and equipment required to support the operation of a QMS. An efficient infrastructure ensures that all processes function smoothly and that the organization can meet quality objectives.

Management System:
A management system is the framework of policies, procedures, and processes that an organization uses to ensure it can fulfill all its tasks to achieve its objectives. In a QMS, it refers to the methods an organization employs to control quality and improve performance.

Quality Management System (QMS):
The Quality Management System is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve effectiveness and efficiency.

Work Environment:
The work environment refers to the conditions under which work is performed, including physical, environmental, and other factors such as safety, ergonomics, and organizational culture. A supportive work environment is critical for the success of the QMS, as it influences employee performance and product quality.

Metrological Confirmation:
Metrological confirmation ensures that measurement instruments and processes are accurate and reliable. In the QMS, this process verifies that the tools used for measurement and calibration meet defined requirements.

Measurement Management System:
The measurement management system controls the measurement processes and ensures that measurement results are reliable and consistent. This system is crucial in maintaining product and service quality.

Policy:
A policy is a formal statement of intentions and direction, guiding decision-making in an organization. In the QMS, policies provide the foundation for setting and achieving quality objectives.

Quality Policy:
The quality policy is a formal statement from top management outlining the organization's commitment to quality. It serves as a guiding principle for the development and implementation of the QMS.

Vision:
A vision defines the long-term aspirations of an organization. In the QMS context, the vision reflects the organization’s commitment to delivering quality and continuous improvement.

Mission:
The mission is the organization’s purpose, outlining what it aims to achieve in terms of product and service quality. It provides a clear understanding of the organization’s core objectives.

Strategy:
A strategy is the plan of action designed to achieve the organization's vision and mission. In the QMS, the strategy includes how the organization will meet its quality objectives, manage risks, and continually improve its processes.