ISO 9000 primary standards
The ISO 9000 series consists of four primary standards supported by several other documents. The four primary standards are:
 ISO 9000, Quality management systems – Fundamentals and vocabulary;
ISO 9001, Quality management systems – Requirements;
ISO 9004, Quality management systems – Guidelines for performance improvements; and
ISO 19011, Guidelines for quality and/or environmental management systems auditing. |
ISO published the first three standards in December 2000. ISO 19011 was published in October 2002.
The ISO 9000 standards were published initially in 1987, revised for the first time in 1994, and revised for the second time in 2000. ISO 19011 is a joint auditing standard for quality and environmental management systems. It replaces six older standards in the ISO 9000 (quality) and ISO 14000 (environment) families: ISO 10011-1, ISO 10011-2 and ISO 10011-3 in the ISO 9000 family and ISO 14010, ISO 14011 and ISO 14012 in the ISO 14000 family. Standards are reviewed every five years to ensure that they are current and satisfy the needs of users.
ISO 9000 is a starting point for understanding the standards, as it defines the fundamental terms used in the ISO 9000 family or set of standards for quality management. ISO 9001 specifies the requirements for a quality management system which enables you to demonstrate your ability to provide products that fulfil customer and applicable regulatory requirements; it also aims to enhance customer satisfaction. ISO 9004 provides you with guidance on the continual improvement of your quality management system so that the needs and expectations of all interested parties are met. These interested parties include customers and end-users, directors and staff in the organization, owners and investors, suppliers and partners, and society at large.
ISO 9001 and ISO 9004 are a consistent pair of standards that relate modern quality management to the processes and activities of an organization, and emphasize the promotion of continual improvement and the achievement of customer satisfaction. ISO 9001, which focuses on the effectiveness of the quality management system in meeting customer requirements, is used for certification or for contractual agreements between suppliers and buyers. By contrast, ISO 9004 cannot be used for certification as it does not prescribe requirements but provides guidance for the continual improvement of an organization’s performance. ISO 9001 focuses on effectiveness, i.e. doing the right things, whereas ISO 9004 emphasizes both effectiveness and efficiency, i.e. doing the right thing in the right way.
The ISO 9000 quality management system is generic in nature: it is applicable to both the manufacturing and services sectors, and to enterprises of all sizes, including the single entrepreneur. ISO 9001 specifies what an enterprise is required to do, but it does not indicate how this is to be done, thus giving the enterprise much flexibility in running its business.
Eight quality management principles
ISO 9000 is based on eight quality management principles:
- Customer focus, resulting in customer requirements being met and in efforts to exceed those requirements;
- Leadership, aiming to create an internal environment in which people are fully involved;
- Involvement of people, who are the essence of an organization;
- Process approach, bringing about improved efficiency in obtaining the desired results;
- System approach to management, leading to improved effectiveness and efficiency through the identification, understanding and management of interrelated processes;
- Continual improvement, which becomes a permanent objective of the organization;
- Factual approach to decision-making, based on an analysis of data and information; and
· Mutually beneficial supplier relationships, derived from an understanding of their interdependence. |
ISO 9000 encourages the adoption of the process approach to company management. The revised process model it sets out takes into consideration the following five main areas:
- Quality management system;
- Management responsibility;
- Resource management;
- Product realization; and
- Measurement, analysis and improvement. |
The process model used in the standards is fully compatible with the well-known PLAN-DO-CHECK-ACT cycle.
Quality management should cover the processes required to achieve quality and highlight their interaction with each other. Top management must lead the development and maintenance of the quality system, and it must encourage company-wide commitment and active involvement in the system. It should provide adequate resources to enable customers to receive what was mutually agreed. It is necessary to have well-defined operational and support processes to be able to realize the product according to expectations. Customer satisfaction has to be measured and analysed so that the organization can be improved continually.