Systematic process improvement using ISO 9001:2000 and CMMI

6.4 Transitioning from ISO 9001:1994 to ISO 9001:2000 203
manuals. However, involving internal staff in the gap analysis has an advantage
over hiring outside auditors, primarily due to the internal staff’s process
knowledge and interest in making necessary improvements to those processes.
Based on the gap analysis results, an organization should define processes
that are comprised in its QMS [7]. This is by far the most difficult step.
Procedures written to satisfy the ISO 9001:1994 requirements may still be
applicable but will require an in-depth review to make sure that they fit the
newly defined processes and can be efficiently applied. The processes may
already exist but they may not be visible, that is, documented and maintained.
ISO does not provide any help in deciding which processes should
be considered. The scope should include not only those processes needed
for product realization, which in most cases will be fairly well defined, but
also those that are needed to manage, monitor, measure, and improve the
production processes.
It is important that organizations determine the big picture first and then
define their processes, process interactions and interfaces, resource needs,
and measurements required to control the processes. Doing this process
definition top down and bottom up is probably the most efficient way,
resulting in larger process ownership. Going top down may appear to be the
most systematic way but it may take too long to determine all the process,
particularly those that are already being practiced. Going bottom up may
enhance process ownership but it may be difficult to abstract processes from
all of the detail.
In general, what the existing processes may lack are the measurement
and control points that have to be determined for providing feedback needed
for process management and control. Here again, the ISO requirements go
beyond simple data collection and analysis. They imply a measurement
process that interacts with the other processes, such as design, production,
and purchasing.
An organization has to determine how it will provide the resources necessary
for production, management, and measurement. Decisions must be
made to address low-level details, such as determining which measurements
are necessary for controlling production and determining customer satisfaction
and deciding how they will be collected. Addressing customer satisfaction
may be another challenge even for those organizations that are already
monitoring it. The ISO standard requires that organizations enhance customer
satisfaction, which implies not only reacting to the customer complaints
but also proactively searching for ways to improve.
What is often neglected is the requirement for training the staff in the
use of the new QMS. The processes embedded in the QMS will be quite