Professional Documents
Culture Documents
The ISO 9000 standards are a set of international quality management standards and guidelines. Since their initial publication in 1987, they have earned a global reputation as the basis for establishing quality management systems. Three of the current standards, ISO 9001, 9002 and 9003, have been used extensively as the basis for independent (third party) quality system certification. This has resulted in the certification of around 300,000 organisations worldwide, with many more in the process of setting up and implementing quality management systems. ISO protocols require that all standards be reviewed at least every five years to determine whether they should be confirmed, revised or withdrawn.
The revised standards are structured in order to facilitate a user-friendlier introduction of Quality Management Systems into an organisation. The common structure of the two standards will follow the typical format of the main processes of an organisation and will enable the Quality Management System to be aligned to its operations. Aims and Mission The primary aim of the "consistent pair" is to relate modern quality management to the processes and activities of an organisation, including the promotion of continual improvement and achievement of customer satisfaction. Furthermore, it is intended that the ISO 9000 standards have global applicability. Therefore, the factors that are driving the revision process, among others, are: Applicability to all product categories and to all sizes of organisations. (Note that the ISO 9000:2000 definition of "Product" also includes "services") Simple to use, clear in language, readily translatable and easily understandable. Ability to connect Quality Management Systems to organisational processes. Provision of a natural stepping-stone towards Total Quality Management. Greater orientation toward continual improvement and customer satisfaction. Compatibility with other management systems, such as ISO 14000 for Environmental Management. Need to provide a consistent basis and address the primary needs and interests of organisations in specific sectors such as aerospace, automotive, medical devices, telecommunications, and others. In this way, all organisations, whether private or public, large or small, producing manufactured goods, services, or software, are being offered tools with which to achieve internal and external benefits. In the revisions of the standards there will be a single Quality Management Requirements standard, ISO 9001:2000, applicable to all organisations, products and services, which will replace the current three quality assurance standards ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994. This may be used for the certification of Quality Management Systems and may also be the basis for contractual agreements. ISO 9004:2000 will be the Quality Management System Guidance standard. ISO 9004 is designed to go beyond quality management requirements to a holistic approach to quality management in pursuit of operational improvement and benefits to all interested parties.
The Revised Quality Management Standards ISO 9001 and ISO 9004
Main Features Major changes in the revised ISO 9000 standards are the increased focus on top management commitment and customer satisfaction, the emphasis on processes within the organisation, and the introduction of continual improvement concepts. The revisions of ISO 9001 and 9004 are based on eight quality management principles that reflect best management practices. A draft brochure, detailing these quality management principles, has been prepared as guidance to the international quality experts who are participating in the preparation of the new standards. These eight principles are: Customer focused organisation Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationship Features will include the continuity and compatibility between the old and new versions of the standards. With the revised ISO 9001, the Quality Management System will cover those activities of an organisation that provide assurance to customers that their needs are being addressed. The enhancement in the revised ISO 9001 of the continual improvement concept is intended to help an organisation respond to the changing needs of its customers, while stimulating the efficiency of the organisation and improving its competitive position. The consistency of the two standards will also support a smooth transition for organisations wishing to go beyond ISO 9001 to ISO 9004.
The revision of the ISO quality management standards includes a significant change to the structure of ISO 9001 and ISO 9004, which, while retaining the essence of the original requirements, will reposition the 20 elements of the current ISO 9001:1994 and the guidelines of ISO 9004-1:1994 into four main sections: - Management responsibility - Resource management - Product realization - Measurement, analysis and improvement Sequence
There is a more logical sequence of requirements and guidelines due to the process orientation of the new standards Top Management
More emphasis has been placed on the role of top management, which includes its commitment to the development and improvement of the quality management system, with a customer focus, consideration of statutory and regulatory requirements, and establishment of measurable objectives at relevant functions and levels. Continual Improvement
An enhanced requirement for continual improvement has been introduced, as anticipated, into ISO 9001, defining a complete cycle to improve the effectiveness of the quality management system. Application
The concept of exclusions to the requirements of ISO 9001:2000 has been introduced as a way to cope with the wide spectrum of organisations and activities that will be using the new standard, via clause 1.2 "Application". Customer Satisfaction
Another new item that has been introduced into ISO 9001:2000 is the requirement for the organisation to monitor information on customer satisfaction as a measure of system performance.
Resources
Attention has been placed on top management to provide and make available the necessary resources. Requirements now include evaluation of the effectiveness of training, provision of relevant information, internal and external communication, facility needs, and human and physical factors of the work environment. Terminology
It should be noted that changes have also occurred in terminology. The most important changes concern the use of the term organisation instead of supplier, still used in the current standards, and the use of the term supplier instead of subcontractor. These changes respond to the need of being more consistent and friendly with the normal use and meaning of the words. Documentation
The number of requirements for documented procedures has been reduced in ISO 9001:2000, and the emphasis placed on the organisation demonstrating effective operation. Other changes
Other detailed changes of a less strategic nature are also being studied, wherever possible with the intention to simplify or clarify requirements of the existing standards, and to make them more "user-friendly".