Also check out our Plain English Process Audit Program.
9001, ISO 9004, ISO
13485, and AS9100
use a process approach.
The process approach is a
management strategy. When managers use
But, what’s a process, and
what are inputs and outputs? Briefly put, a
Processes are interconnected because
the output from one process
Since the process approach is now
central to ISO’s approach, we
1. Quality Management
However, this does not exhaust the list of possible
At an abstract level, a
process-based quality management system can
As mentioned earlier, inputs and outputs are
really the same thing.
While it is easy to see how products and services
can be thought
In summary, a quality management
system is made up
think about all the processes that make up a quality
For this reason, we suggest that you diagram one
process at a time using
The box in the center of the above diagram is
the process you want
Section 4.2.2 of ISO 9001 expects you to
develop a quality manual.
Notice that it doesn’t tell you to “regurgitate”
the ISO 9001 standard. We
Notice also that a quality manual is not a
quality system. A quality
This is an important point. It's important
because many people sell quality
If you use our approach, your quality manual
should be pretty short.
Regarding procedures, we suggest that you
define them in a separate
We also suggest that you develop a procedure for
Based on the above discussion, you will have three
different sets of
Of course, your flowcharts may not look like
ours. That’s fine. Just
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