ISO 9001 Quality Management System is a world-accepted form of quality management system that envisages increasing customer satisfaction by meeting customer expectations, needs and regulatory requirements. It determines the conditions of Quality Management System in many points from the organizational structure of the organization to the satisfaction level of its customers, from the analysis of the collected data to the effective management of the processes, from internal audits to product design, from purchase to sale. ISO 9001 Standard is mainly a control mechanism. The purpose of this standard is to reduce, eliminate and, more importantly, prevent errors and defects. The standard is not directly related to product and service quality, but rather to the quality of the management system. The basic assumption is that if an effective Quality Management System is established and implemented, quality products and services will be produced to meet customer needs.
It can be applied to any sector regardless of large or small scale. It represents a strong management system when properly understood and applied correctly. The ISO 9001 Standard has left it entirely to the organizations to establish the Quality Management System. What needs to be done is not to create a "standard" Quality Management System, but to create a Quality Management System that meets the requirements of the standard.
The process for installation is usually as follows.
Training activities
Everyone from the lowest level employee to the top level executive in the organization should be familiar with the Quality Management System and ISO 9000 standards. Generally, these activities are carried out by a project team established within the organization. In the first step, training needs of the employees are determined and trainings are organized.
System installation works
This step identifies all activities of the organization and analyzes the business processes of each. All processes are documented in accordance with the requirements of the ISO 9001 standard. The point to be considered in this study is the efficiency of the organization. The aim is not to meet quality standards, but to configure these standards to meet the needs of the organization. The work processes prepared by this study will reveal the implementation instructions and procedures of the organization.
Pilot application studies
Once the documentation is complete, the system will be installed, but it is not the right approach to start the whole application at once. When installing the system, new rules may be set and the way the work is performed may be different. These changes should be made public. Therefore, it is best to start from a certain point.
Correction work
If the installed system has non-depleting points, this will occur during the pilot application. There may be points unthinkable during system installation. Determined rules may cause difficulties in implementation. After these arrangements are made, the system established will be extended to the whole organization.
Internal audit activities
Internal audit and management review is also a standard of the ISO 9001 Quality Management System. This work is the sine qua non of the system.
Certification studies
Once the system is installed, certification work can now begin. At this stage, a certification body will be selected and a certification application will be made.
