Systematic process improvement using ISO 9001:2000 and CMMI

4.1 ISO 9001:2000 77
measured, and compared against expected results and objectives. In accordance
with the steps identified in the planning process (Section 7.1), products
are monitored and measured to ensure that they satisfy their requirements.
Product measurements are integral parts of product realization, specifically
product verification and validation. Here, we reconfirm that process and
product measurements are an integral part of the other QMS processes.
Control of nonconforming product (8.3) An organization must ensure that
products that do not meet requirements are not delivered to the customer
or otherwise improperly used. The applicable requirements include not only
the explicitly specified customer requirements, but also the requirements of
the organization’s quality system and the customer’s intended use of the
product.
The nonconforming product must be identified to prevent its accidental
use. The cause(s) of the nonconformity must be found and eliminated. One
of the few documented procedures in the standard is required here. The
procedure must specify the processes for detecting the nonconformance,
performing the causal analysis, identifying the product, and determining the
disposition of the product (e.g., rework or scrap).
Analysis of data (8.4) Data are collected by processes defined throughout
the quality system, particularly in clauses 8.1 and 8.2 of this section. Without
analysis, however, those data are of little use. Applicable analyses include,
for example, those that examine the following:
• Effectiveness of the quality system;
• Effects of changes to the quality system;
• Customer satisfaction;
• Product quality;
• Product performance;
• Supplier performance.
Improvement (8.5)
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action