Systematic process improvement using ISO 9001:2000 and CMMI

68 Revised Frameworks: ISO 9001:2000 and the CMMI ®
the personnel. No matter how terse or verbose the QMS documentation, it
must be sufficient to implement effective and efficient planning, operation,
and process management. Documents needed for management and control
of the QMS have to be controlled, regularly reviewed, and updated. Records
generated by executing the process have to be collected and controlled to
provide evidence that requirements have been met.
A notable feature of the standard is the minimal amount of prescribed
documentation. ISO 9001:2000 has explicit requirements for only six documented
procedures: (1) document control, (2) control of records, (3) conducting
audits, (4) nonconformity control, (5) corrective action, and (6)
preventive action. Although very sparsely worded, this section of ISO 9001
has significant implications and impacts the entire QMS. First, an organization
has to determine the scope of the QMS—decide what is included and
excluded from the QMS. If dictated by the nature of the organization or
product, some requirements in Part 7 of the standard may be excluded from
the QMS documentation as long as the ability to meet customer requirements
is not affected. Such exclusions must be identified and justified.
Then, the organization must document its processes, including the interactions,
for example, among management, human resource, and product
realization processes. Many organizations will find it much easier to document
their product realization processes than their management or human
resource processes. In many cases, identification of a critical process chain will
be needed to completely describe how these processes are used to satisfy
customer requirements and to ensure process efficiency and effectiveness.
After processes are documented, they must be implemented. In some
cases, a process already exists in the organization and will only have to
be captured and documented. Invariably, however, some aspects of some
processes will not yet have been implemented, such as measurement collection
and analysis. For such processes to be effective, staff will require training
to understand what is needed to develop and implement the missing steps,
to collect records, and then, after analyzing the data, to make necessary
corrections. The measurement and analysis process is often poorly understood,
and many organizations will need to devote significant time and effort
to achieve effective implementation.
The relationships between management and measurement processes will
also have to be understood and captured in the QMS so that questions like
these can be answered:
• How long will it take to execute a process
• What kinds of resources are needed: physical, human, financial