ISO 9001 QUALITY MANAGEMENT SYSTEM
In today’s world, the great development that are happening in the field of information, technology and communication where new developments occur every day are being dragged the societies into a fierce competition and economic race. The globalization of the world trade has expanded the scope and boundaries of this competition, and the number of participants in the race has increased steadily. Moreover, those who participate in this race are more qualified every day. Customers are now more conscious, more knowledgeable and customer expectations have reached the highest level. Now to meet client expectations is not only enough, but passing beyond client expectations is also a need. The developments have been made possible before the unthinkable by the increase of the pace of change, especially in the field of technology. It is very difficult for organizations not able to keep up with the change and pace of change. Businesses can only survive by providing goods or services that are consistent with customer needs and expectations in all sectors. For this reason, it is an indispensable condition to implement the Quality Management System, which covers all phases from design stage to production, marketing and after sales services and targets continuous improvement. The ISO 9000 Quality System Standards have become the most popular and applicable international standards since its publication date (1987). The ISO 9000 Quality Management System Standards Series envisions how an effective management system can be set up, documented and maintained. The ISO 9000 Quality Standards Series is a set of standards published by the International Standards Organization (ISO) that guides organizations in the establishment and development of the Quality Management System to enhance customer satisfaction. ISO 9001 is the standard that defines and certifies the requirements to be applied during the establishment of the Quality Management System. However, there are guideline standards that the International Standards Organization (ISO) has published. ISO 9001 and guiding standards are called ISO 9000 series. The following ISO 9000 standard series has been developed for the creation and implementation of an effective Quality Management System of all types and sizes.
ISO 9000 Quality Management Systems - Basic Principles, Terms and Definitions:
The ISO 9000 Standard describes the basic principles of quality management systems and defines the terminology of quality management systems. It can be seen as a kind of dictionary.
ISO 9001 Quality Management Systems - Terms:
The ISO 9001 Standard specifies the requirements of a quality management system when an organization needs to prove that it is capable of delivering products that meet customer requirements and applicable regulatory requirements, and to improve customer satisfaction. It is the documented standard.
ISO 9004 Quality Management Systems - Guide for Performance Improvements:
ISO 9004 Standard provides guidance information taking into account for the effectiveness and efficiency of the quality management system. The aim of this standard is to improve the performance of the organization and to ensure the satisfaction of customers and other interested parties.
The ISO 9001 Quality Management System is a formally recognized quality management system that envisages increasing customer satisfaction by meeting customer expectations, needs and regulatory requirements.
It defines the requirements of the Quality Management System from organizational structure to customer satisfaction level, from analysis of collected data to effective management of processes, from internal audits to product design, from purchasing to selling. ISO 9001 Standard is mainly a control mechanism. The aim of this standard is to reduce errors and defects, to remove them from the ground, and more importantly, to prevent errors and imperfections. The standard is not directly related to product and service quality but to the quality of the management system. The basic assumption here is that an effective Quality Management System should be established and, if implemented, quality products and services to meet customer needs.
The ISO 9001 Standard is not compulsory and includes general requirements. It can be applied to any sector without big or small scale distinction. It represents a strong management system when correctly understood and applied correctly.
The ISO 9001 Standard has left the establishment of how to build the Quality Management System. It is not a "standard" Quality Management System that needs to be done, but a Quality Management System that meets the requirements of the standard.
It is a health and safety mark applied in the framework of the “New Approach” of the European Union in 1985 with the aim of providing free movement of goods. It is intended to use a uniform EU mark indicating compliance with EU directives instead of the different conformity markings used throughout the EU.
The CE Mark is a sign of conformity with the New Approach Directives of the European Union, which indicates that the product on which it is affixed is healthy and safe in terms of human, animal and environment. It is not possible for a product falling within the scope of one or more of the New Approach Directives, which currently is 25, to enter the EU market without carrying the CE Mark. To prove compliance with the New Approach Directives, manufacturers have a great deal of ability to manufacture in compliance with the harmonized standards for the directives. Must comply with the standards
the assumption of proper production in the directive encourages the manufacturer to comply with the standards.
CE mark; is not a quality symbol but a sign that the product to which it is affixed is a sign that it meets all the requirements of the relevant directive and that it provides free movement of goods among the Member States of the European Union.