ISO 9001:2000

ISO 9001:2000 was originally released on December 15, 2000 as ISO 9000:2000(E). The standard had a transition period of three years, which ended on December 15, 2003, resulting in the previous standard, ISO 9000:1994, becoming obsolete.

To help organizations better understand the differences between ISO 9001:2000 and the previous standard ISO 9000:1994, TÜV has developed the following overview providing a comparison of the two standards.

For a list of frequently asked question regarding ISO 9001:2000, click here.

The ISO 9001 standard was revised to implement a number of improvements requested by users. Key changes compared to the previous 1994 Standard include:

• Consistency within the ISO 9004 structure
• Improved compatibility with other management systems, in particular environmental management systems
• Ease of use in all areas and for all types of product, including services
• Ease of use for small companies
• Adapting to a company's existing situation
• Enhanced requirements relating to continuous improvement and customer satisfaction
• A more active role and responsibility for top management

Simultaneously, the following vocabulary was standardized:

The new ISO 9000 series consists of:

• ISO 9000:2000: Quality Management Systems - Fundamentals and Vocabulary
• ISO 9001:2000: Quality Management Systems - Requirements
• ISO 9004:2000: Quality Management Systems - Guidelines for Performance Improvement

Process model ISO 9001:2000

Any activity or operation which receives inputs and converts them to outputs can be considered as a process. Essentially all production and/or service activities and operations are processes.

For organizations to function, they have to define and manage numerous interlinked processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the 'process approach' to management.

This International Standard encourages the adoption of the process approach for the management of the organization and its processes, and as a means of readily identifying and managing opportunities for improvement.

Figure 1 gives a conceptual presentation of the generic quality management system requirements specified in this International Standard, as a 'process model'. The model reflects graphically the integration of the main chapters 4, 5, 6, 7 and 8 given in the standard.

It is not intended to reflect processes at the detailed level. However, all the requirements of a quality management system for achieving conformity of product and/or services may be placed within the model.

Since figure 1 is a model of the complete quality management system processes, it is also capable of demonstrating the interaction between processes.

For example, management defines requirements under Management responsibility (section 5); necessary resources are determined and applied within Resource management (section 6); processes are established and implemented under Product and/or service realization (section 7); results are measured, analyzed and improved through Measurement, analysis and improvement (section 8). Management review (section 5.6) then provides feedback to Management responsibility for change authorization and initiation of improvement.

As an example of the product and/or service realization, the model recognizes the fact that customers and other relevant interested parties play a significant role during the process of defining input requirements. Process management is then implemented for all the processes required to realize the required quality of product and/or services and the process outputs are verified. Customer satisfaction measurements, and satisfaction measurements of other relevant interested parties, are used as feedback to evaluate and validate whether customer requirements have been achieved.

Successful management of an organization calls for clear leadership and control. Management may apply the eight principles outlined below to improve the organization's performance capability. These principals form the basis of the ISO 9000 series of standards.

1. Customer Focus:
Organizations depend on their customers and therefore should understand, satisfy and strive to surpass present and future customer expectations.

2. Leadership:
Top management defines quality policy and should therefore create an environment which enables personnel to be fully committed to quality objectives.

3. Involvement of employees:
Employees are an organization's capital. Employees only use their skills and abilities to achieve maximum benefits for the organization, if they are fully involved in the quality process.

4. Process approach:
Targeted results can be efficiently achieved if activities and the pertinent resources are managed and controlled as processes.

5. System-oriented management approach:
Organizations in which linked processes are recognized, understood, managed and controlled as a system characterized by interaction are in a better position to achieve their goals in an effective and efficient manner.

6. Continual improvement:
Continual improvement of the organization's overall performance is the latter's permanent goal.

7. Objective decision-making approach:
Effective decisions are based on the analysis of figures, data and information.

8. Supplier relations are mutually interdependent:
An organization and its suppliers depend on one another. Relations based on mutual benefits enhance value on both sides.

ISO 9001:2000
Key differences to ISO 9001:1994

Correspondence of chapters/sections between ISO 9001:1994 and ISO 9001:2000.

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