Process Approach

Introduction
All organizations use processes to achieve their objectives. As per ISO
definition
“A process: the set of interrelated or interacting activities
that use inputs to deliver an intended result
NOTE: Inputs and outputs may be tangible (e.g. materials,
components or equipment) or intangible (e.g. data,
information or knowledge).”

The process approach is the foundation upon which your QMS must
be developed. The ISO 9001 Standard promotes the adoption of a
process approach when developing, implementing and improving the
effectiveness of a quality management system, to enhance customer
satisfaction by meeting customer requirements.ISO 9001:2008
promoted the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality
management system. ISO 900:2015 makes this more explicit (in 4.4)
by expanding the requirements around QMS Processes – specifying
requirements considered essential to the adoption of a process
approach. For example, determining the inputs required and outputs
expected from these processes , then after determining the risks and
opportunities and plans to address these in 6.1 – integrate these into
its QMS processes(4.1.f – plan and implement actions), related
performance indicators (4.4.1c.), assignment of responsibilities and
authorities for these processes (4.4.1 e).

For an organization to function effectively, it has to identify and

manage numerous linked activities. Any activity, using resources and
managed in order to enable the transformation of inputs into outputs,
can be considered a process. Often the output from one process
directly forms the input to the next. The application of a system of
processes within an organization, together with the identification and
interactions of these processes, and their management, can be
referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it
provides over the linkage between the individual processes within the
system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach
emphasizes the importance of:
 An understanding of the intended results and requirements
 Consideration of processes in terms of adding Value and
effective performance
 Improvement of processes based on evaluation of data and
information
 Consistent and predictable results
 Meeting requirements and customer satisfaction
 Activity understanding and management of interrelated
processes

The model of a process-based quality management system shown in

figure illustrates the process linkages presented in clauses 4 to 10.
This illustration shows that customers requirements, the needs, and
expectations of relevant interested parties along with the organization
and its context play a significant role in defining requirements as
inputs. The output of the process is the result of the QMS that includes
product and service the organization provides, which should result in
Customer satisfaction. The model shown in Figure covers all the
requirements of this Standard but does not show processes at a
detailed level.

Understanding Process :
Let’s understand some basics about processes.
 All work generally involves a process – things go in (inputs);
get worked upon (conversion), and come out differently
(output). The value-adding conversion activity within a
process transforms inputs into outputs, e.g. takes raw
materials (the input) and manufactures (the value-adding
conversion activity using various resources) a product (the
output).
 Process inputs and outputs can be tangible such as raw
materials or finished product or intangible like
INFORMATION – e.g. computerized drawing or
specification.
 All processes have a supplier and a customer. These
suppliers and customers may be internal processes or
external to your organization. Each process must have an
accountable owner, i.e., having defined responsibility and
authority to operate, control and improve their process.
 All processes require the use of resources, e.g. – people,
equipment, materials, technology, etc. These resources can
be used as inputs (raw materials or information such as a
customer specification) as well as for the value-adding
conversion activity (e.g. use of machinery, equipment,
computers, technology, people, etc.) to transform raw
material (input) into finished product (output).
 All processes must meet customer, organizational and
applicable regulatory requirements. The performance of all
processes can be monitored and measured. Gather
performance data that can be analyzed to determine process
effectiveness and whether any corrective action or
improvement is needed.
As an example, the below process contains a set of activities that are
interrelated (showing links from/to), interacting (showing inputs/
outputs), and the transformation of process inputs into process
outputs.
Schematic Representation of the elements of single process

Procedures are typically used to control deviation where risk/hazards

are present. It is defined as a specified way to carry out an activity or a
process’, which may be a documented set of instructions, or simply an
established way of doing a specific task that itself forms part of a
larger process. In ISO 9001:2015 this might be considered captured,
in the main, by’the availability of documented information that
defines: the characteristics of the products to be produced, the
services to be provided, or the activities to be performed. An
organization’s QMS processes may be grouped or categorized in many
ways. One logical way would include the following:

Customer Oriented Processes (COP’s):

These are product realization processes that determine customer

requirements (inputs), design, make, deliver and service product
(outputs) to customers and determine customer satisfaction. These
processes generally have the greatest degree of interaction with
external customers. COP’s includes marketing and sales, design and
development, production, shipping, packaging, servicing/ warranty,
customer satisfaction, etc., whether performed onsite or off-site.

Support Oriented Processes (SOP’s) :

These processes provide the necessary resources to COP’s to facilitate

product realization. These processes generally have the greatest
degree of interaction at an operational level with COP’s and to a lesser
degree with other internal QMS processes. SOP’s includes human
resources, information technology, purchasing and receiving,
laboratory, maintenance, tooling, facility management, etc, whether
performed onsite or off-site.

Management Oriented Processes (MOP’s)

These processes provide the commitment, leadership, resources,

review, and decision-making by top management.  These processes
generally interact with all QMS processes at the QMS planning and
review level. MOP’s includes business planning, management review,
quality planning, resource planning, communication, etc., whether
performed offsite or on-site.

Quality Management Processes (QMP’s):

It includes all process which is used to document, measure, analyze

and improve all processes. These processes provide quality
management support to and interact with all QMS processes. QMP’s
includes document control, records control, monitoring and
measurement of processes and product, internal audits, control of the
nonconforming product, corrective and preventive action, continual
improvement, etc whether performed onsite or off-site.

Outsourced Processes (OP’s):

An “outsourced process” is a process that the organization has

identified as being needed for its quality management system (QMS),
but one which it has chosen to be carried out by an external party
outside the managerial control of your facility and not subject to your
QMS. These could include MOP’s, COP’s or SOP’s. They may be
performed onsite or off-site. These processes may include – strategic
planning is done at head office; purchasing or design done at head
office or another location; heat treating; painting; welding,
calibration; testing; sort; HR; etc., done by an outside organization.

Implementing QMS using Process Approach

Your QMS is made up of a network of these value-adding processes
that link, combine and interact with one another to collectively
provide product or service. These processes are inter-dependent and
can be defined by complex interactions. For example, any of the COP
processes could interact with some or all of the MOP’s, SOP’s, QMP’s.
Also, note that resources (SOP’s) and QMP’s may also be applied to all
other processes.
Interactions between QMS processes may occur at any of the three
process stages (input, output or conversion activity). The interaction
may occur in many different ways – physical, documentary, verbal,
electronic, etc. For each process, we must identify these interactions,
assess the risks of problems that may occur and implement
appropriate controls to prevent them, e.g., if orders are communicated
verbally by sales personnel to production, what is the risk that
production errors will occur?
Therefore, in general, in order to plan and implement your QMS using
the ‘Process Approach’, you must:
 Identify the processes needed for the QMS.
 Determine their sequence and interaction(show the
sequence and interaction of your COP’s). There are many
ways to document this, e.g., a high-level flowchart or a
process map.
  Determine the application of QMS processes throughout the
organization (show how MOP’s; SOP’s and QMP’s are
applied to each COP and to each other). There are many
ways of documenting this. A popular way is through
graphical representation, e.g. process maps.
 Determine (plan) the criteria, methods, information,
controls, and resources needed for each QMS process.
 Identify the internal/external customer-required output.
 Describe the processing activity that produces the output.
 Identify the resources needed for the processing activity.
 Identify the inputs for the process – information, materials,
supplies, etc.
 Define the process methods, procedures, forms, etc., that
may be needed to produce the output.
 Define the controls to prevent or eliminate the risk of errors,
omissions, or nonconformities in process activity. controls
may come from the IS standards; customer; regulatory and
your own organizational requirements
 Interaction with sources that provide the inputs (internal
processes or external supplier), uses the output (internal
processes or external customer), or provide the resources
(internal support process) to perform the process activity.
 Implement your QMS according to your plan.
 Monitor, measure and improve each QMS process and its
interaction with other processes. Performance indicators to
monitor and measure process performance may come from
the IS standard, customer, regulatory and your own
organizational requirements. Performance indicators may
relate to the process output as well as the process activity.
 Performance indicators for process output must focus on
meeting customer and regulatory requirements.
Performance indicators for process activity should focus on
measuring process effectiveness and efficiency.

It is useful to point out that while we do need to identify all QMS

processes and describe their interaction, not all identified QMS
processes need to be documented or documented in the detail
described above.