Systematic process improvement using ISO 9001:2000 and CMMI

176 Transitioning from Legacy Standards
Because the ISO 9002 and 9003 documents were eliminated, ISO
9001:2000 allows organizations to exclude some requirements of clause 7
of the standard providing that those exclusions do not affect its ability to
provide products that satisfy the customer’s requirements. For example,
design control may be omitted if the organization is not involved in design
activities.
Whereas the 1994 version focused on the prevention of nonconformities,
the focus of the 2000 version is on effective implementation of a system
engineering approach and continual process improvement. The process engineering
aspects of a QMS and, in turn, the quality manual are emphasized
through requirements for definitions for the following:
• Processes needed for the QMS;
• Process sequence and interaction;
• Criteria and methods needed for effective execution of these
processes;
• Resources needed for implementing the processes;
• Measurement and monitoring of the processes;
• Continual improvement.
Several clauses deal with customer focus and the responsibility of senior
management to address customer focus in the form of policies, commitment
to complying with the customer requirements, and continual improvement
of the effectiveness of the QMS. The documentation requirements are also
reduced: Only six procedures are now required as indicated in Tables 6.4
through 6.8.
The language in ISO 9001:2000 is now applicable to all types of organizations,
unlike the language of the 1994 version, which many considered to
be focused on manufacturing organizations. From the implementation point
of view, one of the most significant differences is the shift from the procedural
approach found in 1994 version to the process and systems engineering
approach of the 2000 version. The famous 20 clauses of the 1994 version
have been replaced by five elements. Although many clauses can be traced
to the 1994 version, the focus of the 2000 version is quite different: All
activities revolve around customer satisfaction and continual process
improvement.
Several reports and books address the differences between these two
standards [6, 8, 9]. Major differences, based on [6], are summarized in Tables
6.4 through 6.8.