Systematic process improvement using ISO 9001:2000 and CMMI

76 Revised Frameworks: ISO 9001:2000 and the CMMI ®
4.1.3.5 Measurement, analysis, and improvement
Measurement is a key element of successful management in every wellestablished
engineering discipline [10]. ISO 9001:2000 has requirements
for planning and implementing measurement, analysis, and improvement
processes throughout the QMS (8.1). Many clauses in this section refer to
clauses in earlier sections, especially Section 4, Quality management system,
and Section 7, Product realization. Through measurement and analysis, one
can quantitatively determine the status of a process, detect changes in its
performance, and then implement corrective actions as necessary. The standard
requires an organization to plan and implement measurement, analysis,
and improvement processes to demonstrate and ensure conformity of its
products to customer requirements and to continually improve the QMS.
Although the standard does not prescribe the analysis techniques, statistical
methods provide effective tools.
Monitoring and measurement (8.2)
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
The standard requires an organization to develop methods for measuring
and monitoring the customer’s perception of how the product satisfied the
customer’s requirements. Methods may include customer surveys, sales
reports (for example, repeat orders or demand), or data obtained from the
field, such as failures, complaints, and compliments.
The standard also requires an organization to perform internal audits to
determine if the QMS has been fully and adequately implemented. These
audits determine, for example, if necessary processes have been defined and
implemented, required resources have been allocated, quality goals and
objectives have been identified, and that the QMS is being continually
improved. The audit uses a documented procedure (note that this is one of
the few required procedures) and is conducted by impartial auditors. The
nonconformances identified in the audit should be corrected and their implementation
verified.
ISO 9001:2000 requires that both processes and products be monitored
and measured and that associated measurement records be maintained. QMS
processes have to be instrumented in such a way that they can be monitored,