Process Approach to

Quality Management Systems

Process Approach to
Quality Management
Systems

New ISO-9000:2008 standards promote the adoption of a

process approach when developing, implementing and
improving quality management system (QMS). Process
approach and its application in quality management
system is explained in the following slides:

What is a
Process?

Any activity, or set of activities, that uses resources to transform

inputs to outputs can be considered as a process.
Outputs from one process are typically inputs into other processes
Overall aim is to add value by planning and controlling processes

What is a process
approach?

Any organization would have many processes depending

complexity of its business and nature of its activities.

upon

To function effectively organizations have to identify and manage

numerous interrelated and interacting processes. Often the output from
one process will directly form the input into the next process.

The systematic identification and management of the processes

employed within an organization and particularly the interactions
between such processes is referred to as the Processes Approach.

What is a process
approach.

At the heart of quality management system are the product

realization processes which add value. In addition to these
processes, which transform inputs to outputs, they need auxiliary
processes to facilitate efficient performance of activities or
operations.
This integrated process approach is schematically shown in figure
1.

Figure 1
Schematic Representation of Process Approach

Top Management Process

Customers/Inte
rested parties

inputs

REALISATION PROCESSES

outputs

Customers/In
te rested
parties

Support Processes

Top management processes include, for example, planning, allocation of resources,

management review, etc.
Realization processes include, for example, customer related processes, design and
development, product realization, etc.
Support processes include, for example, training, maintenance, etc.

Management control through process

approach

Process approach enables effective control over the individual processes

within the system of processes as well as their combination and
interaction.
When used within a quality management system such an approach
emphasizes the importance of:
a. Understanding and meeting requirements.
b. The need to consider processes in terms of added value.
c. Obtaining results of process performance and effectiveness and
d. Continual improvement of processes based on objective measurement.
The model of process based quality management system is shown in
figure 2 on the next slide.

Figure 2

Complete Model of Process based Quality Management System

Continual Improvement

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Management
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Measurement,
analysis &
improvement

Resource
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Product
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Product

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Process based Quality Management System

The model of process based quality management

systems illustrates the process linkages presented in
clauses 4-8 of ISO 9001: 2008 The interrelationship of
these clauses is explained in the following slides.

Continual Improvement

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Management
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Measurement,
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Resource
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Product
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Product

The model assumes that quality starts and ends with the customer, as such it is customer
driven. In the diagram customer is shown on both left and right. Generally it will be the same
customer, but on occasions it could be different one. The system starts with understanding
customers requirements which become input to the quality system. Delivery of product or
service to the customer is the output of the quality system.The model gives importance to
obtaining information on customer feedback shown by dotted arrows on the right.

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Continual Improvement

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Management
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Measurement,
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improvement

Resource
management

Product
realization

Product

The input in the form of customer requirements is fed into product or service planning the first
process in the series of product realization processes. This box contains various activities which
your organization needs to do to make your product or service. After transformation by various
processes the final product or service is realized which is delivered as output to the customer

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Continual Improvement

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Measurement,
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Resource
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Product
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Product

The next box covers activities such as measurement of various parameters in different
processes with reference to the specified standards and generates data about
deviations. These measurements not only include internal measurements, but also
external inputs like field failures, customer feedback, etc. This data is required to be
analyzed to determine corrective and preventive measures as well as improvements in
the processes or products.

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Continual Improvement

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Management
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Measurement,
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Resource
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Product
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Product

The results of analysis and customer feedback information is passed on to the

management to take appropriate decisions for overall improvement of organizations
performance. Management responsibility also covers defining of quality policy,
setting of measurable objectives and necessary planning and documentation of
standard instructions for important processes for guidance of concerned people.

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Continual Improvement

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Management
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Measurement,
analysis &
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Resource
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Product
realization

Product

Management also needs to determine and provide resources, which is addressed

in the forth box (resource management) in the quality management system.
Resources include work space; equipment and people. The management needs
to ensure that people are trained and competent for the tasks assigned to them.

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Continual Improvement

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Management
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Measurement,
analysis &
improvement

Resource
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Product
realization

Product

The data analysis activities shown in the box titled Measurement Analysis and
improvement may identify opportunities for improvements to the quality
management system. This is indicated as the arrow pointing to the box at the top
titled Continual Improvement of the Quality Management System. In addition, top
management as a result of management review may suggest investigation of
potential improvements.

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