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British Standards Institute recently certified CALCE'S Quality System to the requirements of the new ISO 9001:2000 standard, Quality management systems - Requirements. The audit, which resulted in the certification of the Quality System, was performed for two reasons. First, as part of a tri-annual process associated with both the 1994 and 2000 versions of the standard, and secondly to verify that the policies and procedures of the Quality System had been revised and augmented to reflect the new requirements of the standard. These changes required that the Quality System and its policies and procedures be process driven, more customer oriented, apply greater application of quality objectives and quality planning and be subject to continuous improvement. The new standard replaced the 1994 versions of ISO 9001, 9002 and 9003 and becomes the newest member of the ISO 9000 family of specifications.

Perhaps of all the changes made to the 1994 version of the specification, the most important one is concerned with the requirement that organizations "continually improve the effectiveness of the management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management reviews." This requirement imposes on CALCE management the responsibility to insure that problems are identified, analyzed and corrected in a timely fashion and policies, procedures and assignments of authority and responsibility are implemented to prevent recurrence and improve the overall effectiveness of the Quality System.

Key features of ISO 9001:2000 and the changes to the CALCE Quality Management system are:

Process Orientation:

The policies, procedures, and assignments of authority and responsibility documented in the CALCE Quality System Manual are now process-focused. Quality Management System and operational processes have been identified and their sequence and interactions identified. The processes are measured, monitored, controlled, analyzed and actions initiated to achieve continual improvement.

Quality Objectives:

A section has been added to the Quality System Manual and the Quality Management System that is concerned with the use of business and quality objectives. The standard requires that they be established at "relevant functions and levels and be measurable." This affords a measure of the effectiveness of achieving the defined objectives.

Quality Planning:

The standard has broadened the use of planning to encompass the entire Quality System. The 1994 version simply stated that the quality procedures "define and document how the requirements of quality will be met." Through the 2000 version it now requires that management ensure that "the planning of the management system be carried out." This imposes a more disciplined and rigorous planning activity within all quality related activities.

Continuous Improvement:

During the periodic Management Review's CALCE management must now "assess opportunities for improvement and the need for changes to the management system." This is in contrast to the requirements of the 1994 standard that simply required management to "ensure the continuing suitability and effectiveness" of the quality management system.

Numerous changes have been made to the CALCE Quality Management System and these are documented in the CALCE Quality System Manual.