The Formalized System
A formalized system for documenting responsibilities, procedures and processes to achieve quality objectives and policies is called a QMS system. This system directs and coordinates the activities of the organization to ensure the regulatory and customer requirements are met. The efficiency and effectiveness of the organization additionally receives continuous improvements. A QMS system reduces waste, improves processes, lowers costs, engages staff, identifies training opportunities, and sets the direction of the organization.
The History of QMS Systems
The quality management system has been influencing the standardization and quality of businesses since the organization of guilds by the craftsman. These standards controlled the outcomes of processes and products during the Industrial Revolution. The best practices were eventually documented for the outcomes of the processes and products, and became the basis for standard QMS systems. The importance of quality during World War II led the armed forces to begin inspecting almost all products. To make the process easier without losing quality, inspections began including quality techniques.
The American Response
After the war, quality became even more significant. A quality revolution was enjoyed by the Japanese, and their previously shoddy exports improved. By the 1970’s, the United States had been broadsided by Japanese competition in the automobile and electronics sectors. The Americans responded with TQM, or total quality management which emphasized the entire organization. By the 20th century, there were standards to create and implement quality management. These unique systems were referred to as QMS. By the 21st century, QMS was margining with transparency and sustainability. This was crucial for customer satisfaction.
The Benefits of QMS
QMS systems have two main benefits, and affect the performance of the organization. The first is the requirements of the customers are met, so they have confidence in the organization. This leads to additional customers, more repeat business and more sales. The second is these regulations ensure compliance, and products and provisions are resource and cost efficient. This creates room for profit, growth and expansion. Consistent results are achieved, mistakes are prevented, costs are reduced, processes are controlled and defined, and the offerings of the organization are improved.
ISO 9001:2015
The most implemented and recognized standard for quality management is ISO 9001:2015. This specifies the QMS requirements used by organizations in the development of their own programs. There is additionally the ISO 9000 family, the ISO 14000 family, the ISO/TS family and the ISO 19011 for a wide variety of areas such as medical devices, automotive and auditing. The QMS is created to address the unique needs of an organization, but many of the elements are the same. This includes the quality manual, data management, internal processes, data management, quality analysis, opportunities for improvement, customer satisfaction and quality policies and objectives.
Establishing a QMS
When an organization establishes a QMS, the choice must be influenced by the organization’s needs, objectives, services and products. This is influenced by the PDCA, or the Plan-Do-Check-Act. This encompasses design, build, control, deploy, review, measure and improve. The portions of the PDCA help structure and develop the QMS, the processes, and the implementation plans. This portion must be overseen by senior management to ensure customer needs are met, and the driving force behind the system.
The Deployment
The deployment breaks down each process into sub processes, and the staff is educated regarding training tools, documentation, metrics and education. The deployment of the management system is often assisted with the company intranet.
Control and Measure
These are two areas in which the QMS is established, and involves systematic audits and routine. The specifics vary according to the environmental impact, potential risk and size of the organization.
Review and Improve
This establishes the way an audit’s results are handled. The goals are the determination of the processes and objectives. This is communicated to the employees, and the best processes and practices are developed.