0 INTRODUCTION

0.1 General provisions

To create a quality management system requires a strategic decision of top management of the organization. To develop and implement quality management system is influenced by varying needs, particular objectives, the products, the processes employed, the size and structure of the organization. This International Standard is based on eight quality management principles. However, it does not imply uniformity in the structure of quality management systems or uniformity of documentation.

The objectives of the organization:

- Defining and meeting the needs and expectations of its customers and other stakeholders (employees of the organization, suppliers, owners, society), to ensure competitive advantage and the realization of this efficiently and effectively;

- Achieving, maintaining and improving the efficiency and capabilities of the organization as a whole.

Applying the principles of quality management not only provides immediate benefits, but also makes an important contribution to management costs and risks. Considerations related to the benefits management costs and risks are important to the organization, its customers and other interested parties. These considerations concerning the overall effectiveness of an organization can affect:

- Customer loyalty;

- Repeated contacts and treatment;

- Results, such as revenue and market share;

- Flexible and quick response to market opportunities;

- The cost and number of cycles through effective and efficient use of resources;

- Building a chain of processes by which the desired results are achieved well;

- Competitive advantage by improving the capacity of the organization;

- Understanding and motivation of employees to the goals and objectives of the organization and participation in continuous improvement;

- The confidence of stakeholders in the efficiency and effectiveness of the organization, confirmed the financial and social benefits as a result of the organization, product lifecycle management, and reputation;

- The ability to create value for both the organization and for its suppliers by optimizing the costs and resources, as well as by flexibility and speed of joint responses to changing market conditions.

0.2 Process approach

This International Standard aims to use the "process approach" in developing, implementing and improving the efficiency and effectiveness of quality management system to improve stakeholders' satisfaction by fulfilling their requirements.

For effective and efficient functioning of the organization shall determine and manage numerous linked activities. An activity using resources and managed in order to transform inputs to outputs, can be viewed as a process. Often the output from one process directly forms the input to the next.

Application in the organization of processes, along with the identification and interactions, as well as management processes can be considered a "process approach".

The advantage of the process approach is the continuity of control that it provides the interface between individual processes within a system of processes, as well as their combination and interaction.

In applying the quality management system, this approach emphasizes the importance of

a) understanding the requirements and comply with them;

b) the need to consider processes in terms of added value;

c) achieve the results of process performance and effectiveness;

d) continual improvement of processes based on objective measurement.

Shown in Fig. A model of quality management system based on process approach, illustrates the concept of inter-process communication, presented in Sections 4-8. This model shows that the parties play a significant role in determining the input data. Monitoring of stakeholders' satisfaction requires the evaluation of information relating to the perception of stakeholders that the organization fulfills their requirements. Shown in Fig. A model does not show processes at a detailed level.

03. Relationship with ISO 9001

The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of standards for quality management systems to complement each other, but they can also be used independently. Although these international standards have different scopes, they have similar structures to facilitate their use as a matched pair.

ISO 9001 specifies requirements for quality management system that can be used for internal application by organizations, in order to certification or contracting. It is aimed at quality management system in fulfilling the requirements of consumers.

ISO 9004 provides guidance on a wide range of purposes of quality management system than does ISO 9001, particularly for the continual improvement of the organization and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001 in pursuit of continual improvement. However, it is not intended for certification or contracting.

For greater convenience, the basic content of the ISO 9001 requirements placed on the frame after the relevant section of this International Standard.

Information marked "NOTE" is for guidance on understanding or insight.

0.4 Compatibility with other management systems

This International Standard does not contain any specific recommendations in relation to other management systems such as management of environmental management, occupational health and safety, financial management or risk management. However, it allows an organization to align or integrate its own quality management system with related management systems. Organization can adapt its existing system (s) for the management of a quality management system, which follows the recommendations of this International Standard.