• +90 212 702 00 00
  • +90 532 281 01 42
  • I info@muayene.co
trarbgzh-TWenfrkadefaru

ISO 9001: 2015 Quality Management System

Total Quality Management approach is generally found in the companies that produce production. In general, the total quality understanding of the development, if you start with the first inspection, followed by quality assurance standards and finally the Total Quality Management understanding is reached. In all these processes, mainly physical goods were taken into consideration. Therefore, with the understanding of Total Quality Management, the production sector has always been considered together. However, with the ever increasing speed of service sector in recent years, quality and Total Quality Management concept has become a necessity in this sector.

In our country, the course of the developments followed in economic life starts to fall from the west to the east and to show a development in the opposite direction. The basis of this is the organizational structure, management style and activities of the enterprises.

Total Quality Management is based on quality and quality is defined in different ways. According to the definition of Juran, who is considered to be the father of total quality studies, quality is the characteristics that determine how a product or service fits the customer needs. This definition preserves its main philosophy today. A product or service means that it is of high quality, as appropriate to the existing or future customer demands.

In the historical process, the quality control period, which focuses on prevention studies and statistical results, has been passed from the period of inspection to quality. From there, the period in which the activities were carried out according to the determined processes and the quality was started to be documented. This is the period when ISO 9000 Quality Assurance Standards are gaining importance.

In this period, quality understanding, customer-oriented, continuous improvement and management of quality is based on ownership. In short, Total Quality concept was passed to Quality Management System.

Total Quality Management applications have been developed in Japan before then started in America. Today it is practiced all over the world.

The success of the Quality Management System in enterprises depends on a number of factors. These factors vary according to the situation of the enterprise and the culture structure of the society. The main factors are: continuous improvement, customer satisfaction and employee participation.

Continuous improvement is the main factor of the system. Businesses today do not see the current situation, and must go to a better and better. Customer satisfaction is the ability to meet the ever-changing customer demands on time. It is necessary to be a customer-focused place. Customer satisfaction, customer-requested quality of goods and services, in a shorter time and cheaper is to provide. The participation of employees is the third main factor in the success of the system. All employees, from the top managers to the bottom employees, must adopt the system and participate in the activities.

The ISO 9001 Quality Management System standard was first published by the International Organization for Standardization (ISO) in 1987. In the following years, it has been updated several times in parallel with the changes in technology and application. The last update of this standard was made in 2015. In this last amendment, the articles of the standard have been rearranged. In addition, the standard service sector has been made more easily available to businesses. While only the product expression was used before, in this last change goods and services started to be called together.

Following the changes, the main structure of the ISO 9001 standard is as follows:

1. Scope

2. Sampling

3. Term and definitions

4. Organization content

5. Leadership

6. Planning

7. Supporting

8. Operation

9. Performance evaluation

10. Enhance on

A significant change in the ISO 9001 standard is that it brings a risk based thinking perspective to the companies that implement the Quality Management System. At the same time, the integration of business processes with quality management processes has been targeted. In the previous version, the concept of preventive action was taken as the basis instead of risk based thinking.