ISO9000 2000 SUMMARY Introduction

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that all standards be reviewed at least every five years to determine whether they should be confirmed, revised or withdrawn.

Background to the Changes

Surveys have been carried out on a worldwide basis in order to understand the needs of all user groups. The revised standards will take into account previous experience with quality management systems. They will result in closer alignment of the quality management system with the needs of the day to day running of the organisation. It has long been recognised that investment in quality management systems, in addition to responding to customer expectations, has resulted in benefits to the efficiency of the organisation, its operations and economic performance. Specifically, the revised standards will be of great help for organisations wishing to go beyond simple compliance with Quality Management System requirements for certification purposes. They can be readily applied to small, medium and large organisations in the public and private sectors, and will be equally applicable to users in industrial, service, software and other areas.

The Revision Process

The revision process is the responsibility of ISO's Technical Committee TC 176, and is conducted on the basis of consensus among quality and industry experts, nominated by ISO member bodies, and representing all interested parties. For the "Year 2000" revision, TC 176 has adopted a project management approach in order to cope with the complexity of the task. Initial project specifications and goals were established after extensive user surveys had been carried out, to determine needs and expectations for the revisions. Furthermore an essential part of the revision has been the verification and user validation process, to ensure that the standards produced meet user needs.

Essential Changes to the ISO 9000 Series

In order to reflect modern management approaches and to improve organisational practices it has been found useful and necessary to introduce structural changes to the standards while maintaining the essential requirements of the current standards. Prior to the 2000 revisions the ISO 9000 family contains some 27 standards and documents. This proliferation of standards was a particular concern of ISO 9000 users and customers. To respond to this concern, ISO TC 176 agreed that the year 2000 ISO 9000 family would consist of four primary standards supported by a considerably reduced number of other documents (guidance standards, brochures, technical reports, technical specifications). To the extent possible, the key points in the current 27 documents were integrated into the four primary standards, and sector needs will be addressed while maintaining the generic nature of the standards. The four primary standards are: ISO 9000: Quality management systems Fundamentals and vocabulary ISO 9001: Quality management systems - Requirements ISO 9004: Quality management systems Guidance for Performance Improvement ISO 19011: Guidelines on Quality and Environmental Auditing The revised ISO 9001 and ISO 9004 standards were developed as a consistent pair of standards. Whereas the revised ISO 9001 clearly addresses the quality management system requirements for an organisation to demonstrate its capability to meet customer needs, the revised ISO 9004 is intended to lead beyond ISO 9001 towards the development of a comprehensive quality management system, designed to address the needs of all interested parties. Both standards use a common vocabulary as defined in ISO 9000:2000, which also describes the underlying fundamentals. A logical, systematic approach was adopted in formulating the definitions used in ISO 9000:2000, with the intention of generating a more consistent terminology that is "user-friendly". ISO 9001, ISO 9002 and ISO 9003 standards were consolidated into the single revised ISO 9001:2000 standard.

The "Consistent Pair" of Quality Management Standards

The revised ISO 9001 and 9004 are designed to constitute a "consistent pair" of standards. The structure and sequence will be identical in order to facilitate an easy and useful transition between them. Although they will be stand alone standards, the new structure will promote enhanced synergy between the two and will aid organisational efficiency and effectiveness.

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.

Changes being introduced Structure

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".