Dear Friends,

ISO 9004:2000 had been released as a pair of standards with ISO 9001:2000 in Dec
2000.

Now after eight years, this has been forgotten by many, while its usefulness for certified
companies are considered very high.

During subsequent audits, the guidelines are very useful.

Please have a look at the introduction attached here. If you are interested, subsequent parts will be mailed in coming weeks.

Happy reading.

Introduction

General

The adoption of a quality management system should be a strategic decision by the top management of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. This International Standard is based on eight quality management principles. However, it is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

The purpose of an organization is :-

— to identify and meet the needs and expectations of its customers and other interested parties (people in the organization, suppliers, owners, society), to achieve competitive advantage, and to do this in an effective and efficient manner, and
— to achieve, maintain, and improve overall organizational performance and capabilities.

The application of quality management principles not only provides direct benefits but also makes an important contribution to managing costs and risks. Benefit, cost and risk management considerations are important for the organization, its customers and other interested parties. These considerations on overall performance of the
organization may impact

— customer loyalty,
— repeat business and referral,
— operational results such as revenue and market share,
— flexible and fast responses to market opportunities,
— costs and cycle times through effective and efficient use of resources,
— alignment of processes which will best achieve desired results,
— competitive advantage through improved organizational capabilities,
— understanding and motivation of people towards the organization's goals and objectives, as well as participation in continual improvement,
— confidence of interested parties in the effectiveness and efficiency of the organization, as demonstrated by the financial and social benefits from the organization's performance, product life cycle, and reputation,
— ability to create value for both the organization and its suppliers by optimization of costs and resources as well as flexibility and speed of joint responses to changing markets.

Process approach

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness and efficiency of a quality management system to enhance interested party satisfaction by meeting interested party requirements.

For an organization to function effectively and efficiently, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, is considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions and managing of these processes can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

- understanding and fulfilling the requirements,
- the need to consider processes in terms of added value,
- obtaining results of process performance and effectiveness, and
- continual improvement of processes based on objective measurement.

The model of a process-based quality management system illustrates the process linkages presented in clauses 4 to 8.

This illustration shows that interested parties play a significant role in defining requirements as inputs.

Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of interested parties as to whether the organization has met their requirements.

Relationship with ISO 9001

The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other but can also be used independently.

Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.

ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.

ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance 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 of performance. However, it is not intended for certification or for contractual purposes.

For further benefit to the user, the basic content of the ISO 9001 requirements are included in boxed text following the comparable clause in this International Standard. Information marked “NOTE” is for guidance in understanding or clarification.

Compatibility with other management systems

This International Standard does not include guidance specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management, or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management systems. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that follows the guidelines of this International Standard.

Warm Regards

Raghu