CALCE QUALITY SYSTEM
CERTIFIED TO ISO 9001:200
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British Standards Institute certified CALCE'S
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
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:
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.
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.
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.
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
System and these are documented in the CALCE Quality System Manual.