ISO 9003 lists many
requirements. But how do you get from a simple list of
requirements to an integrated
quality management system? In order to get from a list
to a system, you've got to add some structure. This is what we've tried
to do below.
The ISO 9003 requirements can be organized
by grouping them into the following eight sets of program
requirements:
-
Leadership requirements
-
Contract review requirements
-
Inventory management requirements
-
Inspection and testing requirements
-
Nonconformance management requirements
-
Measurement requirements
-
Internal
audit requirements
-
Training requirements
In addition, we have
subdivided each of the above program requirements further into the
following 10 process requirements:
-
Policy requirements
-
Planning requirements
-
Procedural requirements
-
Instructional requirements
-
Personnel requirements
-
Organizational requirements
-
Documentation requirements
-
Record keeping requirements
-
Technological requirements
-
Resource requirements
As you can see, we have
identified eight sets of general requirements, and within each of these
we have identified ten additional requirements. We think of the first
set as program
requirements and the second set as
process
requirements. The first set specifies what programs are
needed and the second set specifies what kind of process each
program should follow.
The first set of eight requirements indicates
what functional areas need to be controlled. These include
areas such as measurement, inspection, and training.
The second set of ten
requirements specify how this control should be exercised
within each of these eight areas and what
form this
control should take. This second set specifies
how quality documents,
data, and records should be managed, what form quality policies, plans,
procedures, and instructions should take, what technologies and
resources are required, and how all of this should be organized.
In other words, the first set points to eight
organizational functions that need to be performed, while the second set
points to the methods, tools, and techniques that should be used to
perform each of these general functions.
We distinguish between these two types of
requirements for a good reason. It allows us to approach the quality
system development process in an organized way. It allows us to
think in terms of eight quality programs that meet eight sets of program requirements. Furthermore, it allows us to develop each of these eight
programs by addressing the ten process requirements that make up each
program. Finally, it allows us to combine these eight quality programs
into a single quality assurance program which, when implemented,
automatically brings a complete quality management system into
existence.
If you use this approach, your Quality
Assurance Program would be made up of the following eight
Quality Programs:
-
Quality Leadership Program
-
Quality Contracts Program
-
Quality Inventory Program
-
Quality Inspections Program
-
Quality Nonconformance Program
-
Quality Measurement Program
-
Quality
Audit Program
-
Quality Training Program
When you implement this eight part
Quality Assurance Program, you will automatically create a
Quality Management System.
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