Introduction

0.1 General provisions

Implementing a quality management system should be a strategic decision of the organization.
Development and implementation of quality management system depends on

a) the external environment and changes in them, the risks associated with external conditions,

b) the changing needs

c) the specific purposes

d) provides products,

e) the processes used,

f) the size and structure of the organization.

This International Standard does not impose a single structure or a single quality management system documentation.
Requirements for QMS specified in this International Standard are in addition to product requirements. Information marked "NOTE" is a guide to understand or to explain the relevant requirements.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to fulfill customer requirements, legal requirements and the requirements of the organization.

Quality management principles set out in ISO 9000 and ISO 9004, were included in the development of this International Standard.

0.2 The approach from the standpoint of the process

For effective functioning of the organization shall determine and manage numerous linked activities. Activity or set of actions, using resources and managed to transform inputs into outputs, can be viewed as a process. Often [hidepost = 3] output from one process directly form the input to the next.

The application of process within the organization, including: determination of their interaction, manage to achieve the desired results, can be defined as a "process approach".

The advantage of the process approach is to-day management, it provides a link between individual processes within a system of processes, as well as their combination and interaction.

When applied under the QMS, this approach emphasizes the importance of:

a) understanding and meeting the requirements

b) the need to consider processes in added value,

c) the results on the effectiveness and efficiency of processes and

d) continual improvement of processes based on objective measurements.

Process-oriented model of SMC presented in Figure 1 illustrates the connection of the processes described in paragraphs 4 through. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information about consumer awareness, the organization met its requirements. The model presented in Figure 1 covers all the requirements of this International Standard, but does not reflect the processes at a detailed level.

NOTE: In addition, all processes can be applied methodology, known as "Plan - Do-Check - Act» (PDCA). PDCA can be briefly described as follows.

Plan: establish the objectives and processes necessary [/ hidepost] to achieve results in line with customer requirements and policies of the organization.

Do: implement the processes.

Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.

Act: take actions to continually improve processes.

Fig.1. Model of quality management system based on processes.

0.3 Relationship with ISO 9004

ISO 9001 and ISO 9004 have been developed as complementary standards QMS, but they can be used independently.

ISO 9001 specifies requirements for [hidepost = 3] SMC, which can be used for internal application by organizations, certification , or for contractual purposes. It focuses on the effectiveness of the QMS in compliance with the requirements of the consumer.

At the time of publication of ISO 9004 is reviewed. The revised version will be the guidance for management to achieve sustainable success of any organization in a complex, evolving and changing environmental conditions. ISO 9004 offers a wider focus on quality management than ISO 9001, calls to assess the needs and expectations of all stakeholders and their satisfaction, the systematic and continuous improvement
the organization. However, it is not intended for certification [/ hidepost] or the use of contract goals.

0.4 Compatibility with other management systems

The revision of this International Standard has been provided consistent with the requirements of ISO14001: 2004 , in order to increase the compatibility of these two standards for the convenience of users.

Appendix A shows [hidepost = 3] interactions ISO 9001:2008 and ISO14001: 2004

This International Standard does not include requirements specific to other management systems, such as inherent environmental management, occupational health and safety, risk, or financial. However, this International Standard enables an organization to align or integrate its own quality management system with the appropriate requirements of management systems. Organization can adapt an existing system (s) [/ hidepost] control to set the QMS comply with this International Standard.