ISO's Process Approach

Our ISO 9001 Internal Audit Program, ISO 13485 Internal Audit Program,
and our Process-based Quality Management System Development Plan
uses a process approach. We use a process approach, not only because it
makes good sense to do so, but also because ISO has made it mandatory.
Clause 4.1 of ISO 9001 and ISO 13485 makes it clear that organizations
must identify and manage the processes that make up their quality
management systems.

The process approach is a management strategy. When managers use
a process approach, it means that they manage the processes that make
up their organization, the interaction between these processes, and the
inputs and outputs that glue these processes together.

But, what’s a process, and what are inputs and outputs? Briefly put, a
process uses inputs to generate outputs. Or, more precisely, a process is
an integrated set of activities that uses resources to transform inputs into
outputs. A system exists whenever several processes are interconnected
using such input-output relationships.

Processes are interconnected because the output from one process
becomes the input for another process. In effect, processes are “glued”
together by means of such input-output relationships. And because the
output of one process becomes the input of another process, inputs and
outputs are really the same thing.

Since the process approach is now central to ISO’s approach, we
have tried to identify the processes that make up a an ISO 9001 2008
Quality Management System (QMS). As the following list shows,
we’ve identified 12 processes:

1. Quality Management Process
2. Resource Management Process
3. Training and Awareness Process
4. Product Purchasing Process
5. Design and Development Process
6. Production Management Process
7. Service Provision Process
8. Product Management Process
9. Customer Relationship Management Process
10. Internal Quality Management Audit Process
11. Monitoring and Measuring Process
12. Management Review Process

At an abstract level, a process-based quality management system can
be diagrammed in the following way. The diagram below shows several
processes interconnected using many lines. These lines represent inputs
and outputs. All of these interconnected processes make up a quality
management system (QMS).

As mentioned earlier, inputs and outputs are really the same thing.
This is because the output of one process becomes the input of another
process. Inputs/outputs can be grouped into four general categories:
products, services, resources, and information.

While it is easy to see how products and services can be thought
of as inputs/outputs, the third and fourth categories deserve some
explanation. Resources can include people, money, energy, and supplies,
while information inputs/outputs can include both tangible and intangible
items. Specifically, information inputs/outputs include tangible items such
as documents, records, and reports, but also more intangible items such
as decisions, instructions, authorizations, expectations, requirements,
complaints, comments, feedback, measurements, plans, ideas,
solutions, and proposals.

In summary, an ISO 9001 quality management system is made up
of many processes, and these processes are glued together by means
of many input-output relationships. Such input-output relationships turn
a loose network of processes into an integrated system. Without such
input-output relationships, you wouldn't have an integrated quality
management system.

When you think about all the processes that make up a quality
management system, and then think about the many input-output
relationships that “glue” these processes together, you soon realize
how complex such a system is. Because of this, you may find it difficult
to create a single map or diagram of your entire quality management
system. There are just too many processes and too many input-output
relationships. As the first diagram above shows, a single map or diagram
may provide a general overview, but it’s usefulness will be limited.

For this reason, we suggest that you diagram one process at a time using
a single flowchart on a single page (as shown in the diagram below). This
will allow you to specify the most important input-output relationships
without getting buried in complexity. The diagram below shows, in
general terms, how this could be done.

The box in the center of the above diagram is the process you want
to focus on. The surrounding processes provide inputs to the central
process and receive outputs from it. The above diagram shows that
an input-output relationship is usually a two-way street. Inputs go
one way and outputs go the other way. Define your inputs and
outputs by labeling the arrows that connect your processes.

We suggest that you use flowcharting software to diagram your QMS.
We recommend SmartDraw, ConceptDraw, or Visio for this purpose.
These products are relatively inexpensive and easy to use.

Section 4.2.2 of ISO 9001 expects you to develop a quality manual.
According to this section, your quality manual should:

Describe how your quality system processes interact.
Define the scope of your quality management system.
- Explain any reductions in the scope of your system.
- Justify all exclusions (reductions in scope).
Document your procedures or refer to them.

Notice that it doesn’t tell you to “regurgitate” the ISO 9001 standard. We
mention this because it’s a common practice. Many people simply copy
the ISO 9001 standard and call it a quality manual. If you plan to follow
this approach, please reconsider. It’s pointless, and may violate ISO’s
copyright. But more importantly, the ISO 9001 standard doesn’t want
you to do it. What ISO does want you to do is comply with section 4.2.2.

Notice also that a quality manual is not a quality system. A quality
manual is just a document, while a quality system is a network of real
processes. Your quality manual is supposed to document your quality
system; it's not supposed to be your system. Your manual is not your
system. They're two different things. Your quality manual is all about
paperwork, while your quality system is a web of real processes.

This is an important point. It's important because many people sell quality
manuals and computer programs that claim to provide an instant solution.
Usually all you have to do is edit the manual or install the program and,
bingo, you've got a complete quality management system. This is false
and misleading. A manual is just a document and a computer program
is just an information system. Your quality system does not sit on your
shelf, nor does it live inside your computer.

If you use our approach, your quality manual should be pretty short.
Simply describe how your quality system processes interact using the
above mapping methods. Once you’ve done this, all you need to do is
define the scope (focus) of your quality management system (including
reductions in scope) and the procedures that regulate how it functions.

Regarding procedures, we suggest that you define them in a separate
document, and simply refer to them within your quality manual. If you
use this approach, updates to either your manual or your procedures
should be much easier to manage.

We also suggest that you develop a procedure for every process.
Every process ought to have a documented procedure that describes
the process, and governs and controls how it is carried out. However,
this is just our opinion. It is not an ISO 9001 requirement. When it is a
requirement, our Process-based QMS Development Plan will mention it.
Procedures, by the way, can be lengthy documents full of detailed text,
or they can be one page flow diagrams. Just make sure that it meets
your organization’s needs and ISO’s requirements.

Based on the above discussion, you will have three different sets of
flowcharts if you decide to use diagrams to document your quality
management system. You will have a single systemic flowchart,
some process flowcharts, and several procedural flowcharts:

Develop a single systemic flowchart for your quality management
system as a whole. While such a document will be rather abstract,
it will help show how your processes are interrelated and integrated
(see diagram 1 above).
Develop one flowchart for each process and use it to describe
how it interacts with other processes using input-output arrows
(see diagram 2 above). This set of process flowcharts will describe
how your processes interact.
Develop one flowchart for each process and use it to describe how
the process should be performed (see diagram 3 below). This set of
flowcharts will make up the procedures that control how processes
should be performed. Such procedural flowcharts usually specify
a start and stop point with actions (tasks or steps) and decision
points in between.

Of course, your flowcharts may not look like ours. That’s fine. Just
make sure they meet your needs and address ISO’s requirements.

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