The first version of ISO 9000 series standards was published in 1987. Initially, this series included in only five standards. The standard for the terminology of quality management that was publishing in 1986 began to belong to the same series.
Three models of a quality management system were established for enterprises and organizations with different production life cycles in the first version of the ISO 9000 series standards. A standard included a guide for choosing a quality system model in order to the organization can determine which of the models should be used. A reference standard on the general management of the quality system was included in the series in order to understand how it is necessary to manage the quality system.
The structure of the ISO 9000 series of standards released in 1987 was as follows:
The construction and certification of quality systems was carried out according to one of the three models ISO 9001, ISO 9002 or ISO 9003.
ISO 9001 was the most comprehensive of the three standards, because it included requirements for all stages of the life cycle of production – from design to maintenance.
ISO 9002 limited the operation of the quality system only to the stages of production, product testing and delivery it to the consumer.
ISO 9003 contained the most minimal set of requirements for the quality system and was limited only to the stage of control and testing of finished products.
Thus, it turned out that the requirements of the ISO 9003 standard were an integral part of the requirements of the ISO 9002 standard, and those, in turn, were an integral part of the requirements of the ISO 9001 standard.
A number of shortcomings of the first version were revealed based on the analysis of the application of the first version of the ISO 9000 series standards. In particular, difficulties were identified with the application of these standards to a number of industries with specific types of products and to enterprises providing services. In addition, there was a need to expand the requirements of the quality system. Therefore, the revision of the series standards was completed by 1994 and a new version of the ISO 9000 series was released.
The series of 1994 included 16 standards. Additional standards were developed. These standards provided recommendations for the development and application of individual elements of the quality system. The ISO 9000 series began to include standards with numbers that go beyond this series starting with the 1994 version.
The new version of the standards has expanded the composition of the requirements included in the models of quality systems. The ISO 9001 standard began to contain 20 elements of the quality system. The implementation of each of them allowed the organization to believe that the quality system was implemented and operational. The ISO 9002 and ISO 9003 standards contained the same requirements, only the inapplicability was indicated for elements that went beyond the scope of the corresponding model.
It should be noted that both the first version of the standards and the 1994 version used a functional approach to the quality system. Each element of the quality system presented in the standard was considered as a independent function to ensure, manage or improve quality.
The approach to building and managing a quality system was revised in the 2000 version of the standards. The work of the organization is considered from the point of view of the processes of this organization, starting from this version.
The version of the standards of 2000 years provides for 4 groups of processes related to the quality management system:
Three models of quality systems were combined into a single model in this version of the standards. The ISO 9001, ISO 9002, ISO 9003 standards were combined into one ISO 9001:2000 standard. All organizations could build a quality system according to a single model, regardless of the type of products and services, as well as the stages of the production life cycle. It was allowed to make exceptions to the requirements of the standard if any stages of the production life cycle were not applied at the enterprise. The quality system model has become more "flexible" and universal.
Significant changes have also taken place in the composition of the supporting standards, as well as the standards providing guidance. In addition, the standards of the 2000 version provided for the relationship of quality management requirements with other management systems, such as environmental management systems, safety management systems, food quality management systems. Thus, enterprises and organizations have the opportunity to build integrated management systems based on the quality management system.
The 2008 version of the standards has not undergone significant changes compared to the 2000 version. The composition of the revised and updated standards was insignificant.
Changes in the following standards should be noted:
Many of the changes made in the 2008 version of the standards are aimed at closer integration of the quality management system with other management systems.
A number of new standards with the status of guidelines have appeared in the ISO 9000 series of standards. These standards clarified certain issues related to the construction and development of a quality management system (for example, guidelines for assessing customer satisfaction or guidelines for the selection of consultants for a quality management system, etc.).
A new version of the ISO 9001 standard was released in 2015. This standard is the key standard of the series, therefore, conditionally 2015 can be considered the year of updating the standards of the 9000 series. In fact, the revision and updating of standards is carried out continuously.
The approach to quality management has been changed in the new version of the ISO 9000 series standards. The main idea was to prevent (reduce the likelihood of occurrence) situations that could negatively affect the consumer. In accordance with this idea the requirements of the ISO 9001 standard have changed. Organizations are required to apply risk-based thinking starting with this version of the standard.
More detailed information on changes to the ISO 9001:2015 standard can be found on the page "Differences of ISO 9001:2015".
Other standards in the series have been modified or adjusted in accordance with the requirements of the risk-based approach.
Updated on 26.04.2020
ISO 9001:2015 Explanations. Interpretation of requirements. Implementation guide.