We have translated the
ISO 9000 and AS9100C quality management
definitions into plain English in order to make them easier to understand.
Our plain English definitions are primarily based on the formal definitions
found in the ISO 9000 standard and on the definitions added by AS9100C.
Also see additional
ISO 9000:2005 Definitions used by
are critical if they
have a major impact on the realization
and use of the product. Items are critical if they have
effect on the safety, performance, form, fit, function, producibility,
or service life of the product. Critical items require specific
to ensure that they are adequately managed.
Examples of critical items include key
functions, processes, and software. They include mission
critical items, safety critical items, and fracture critical items.
is a feature or attribute that has a significant
impact when it varies. Whenever a key characteristic varies, it
important effect on the performance, form, fit, function,
or service life of the product. Therefore, key characteristic
must be controlled.
is an undesirable situation or circumstance that has
two characteristics: it is both likely to occur and likely to cause
The concept of risk is always future
oriented. It worries about
the impact that undesirable circumstances or situations could
have in the future.
A special requirement is a requirement that may be especially
to achieve. Special requirements may be difficult to achieve
they force you to operate at the limit of your organizationís
or process capability or at the limit of your industryís capability.
Either you or your customer may decide that a requirement is special.
In order to figure out whether or not a requirement is special,
the complexity and maturity of your product or process and your
organizationís past experience.
Since there is a risk that your organization may not be able to
meet a special requirement, youíre expected to include it in
risk management process.
NOTE: Critical items, special
requirements, and key characteristics are new
interrelated concepts. Special requirements force you to
operate at or near
the limit of your organizationís capability. Therefore, they tend to
to achieve. In order to meet these difficult requirements you may need
carefully manage critical items. And if such items tend to
vary, you may
also need to treat them as key characteristics in order to
Additional Quality Management Definitions
to Z Index
Praxiom Research Group Limited
Updated on November 27,
First published on August 31, 2009.
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