ISO 9001 Process Approach
What is the definition of a
can be defined as a "Set of interrelated or interacting activities, which transforms inputs into outputs".
These activities require allocation of resources such as people and
What is the definition of the ‘process
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”.
The processes are managed as a system, by creating and understanding a network of the
processes and their interactions (see figure 2). The consistent
operation of this network is often referred to as the "system approach" to
The performance of an organization can be improved through the use of the process
What are the characteristics of
Processes are the foundation upon which your quality management system (QMS) must be developed.
Let’s understand some basics about processes.
1 - 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
Process inputs and outputs can be tangible (raw materials or finished product) or
intangible (information - e.g. computerized drawing or specification).
2 - All process has 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).
The purpose of the process approach is to enhance an organization's effectiveness and
efficiency in achieving its defined objectives. Process effectiveness and efficiency can be assessed through
internal or external review processes.
All processes must also 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
What are the characteristics of the process
major advantage of the process approach, when compared to other approaches, is in the management and control of
the interactions between these processes and the interfaces between the functional structure of the
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 (See Figure
2). 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. (See types of
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?
What benefits does the process approach
integrating, aligning and linking processes effectively to achieve planned goals and
Allows the organization
to focus on improving process effectiveness and efficiency.
performance which in turn provides assurance to customers about the organization’s quality and
Promotes the smooth and
transparent flow of operations within the organization.
Contributes to lower
costs and shorter cycle times, through the effective use of resources.
Focus on continual
improvement of processes results in improved, consistent and predictable
involvement and empowerment of people and the clarification of their
is the process approach different from a departmental approach?
The process approach is an effective way to
organize and manage business activities to create value for the customer and other interested
Organizations are often structured into a hierarchy of functional
These departments are usually managed vertically, with responsibility for the
intended outputs being divided among functional units. The end customer or other interested party is not always
visible to all involved. Consequently, problems that occur at the interface between departments are often given
less priority than the short-term goals of the departments. This leads to little or no improvement to the customer,
as actions are usually focused on the departmental functions, rather than overall benefit to the
The process approach introduces horizontal management of activities, by removing the
barriers between different departments and focusing their collective effort to the main goals of the
How can QMS processes be
grouped or categorized?
An organization’s QMS processes may be grouped or categorized
in many ways. One
logical way would include the following:
Processes(COP’s) - These are product realization processes (see clause 7) 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 include - marketing and sales; design and development; production; shipping; packaging;
servicing/ warranty; customer satisfaction; etc., whether performed onsite or off-site.
Processes(SOP’s) - These processes provide the necessary resources to COP’s to facilitate product
realization and measurement and monitoring activities. 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 include - human resources; information technology; purchasing and receiving; laboratory; maintenance;
tooling; facility management; etc, whether performed onsite or off-site. See clause 6 and 7.
Processes(MOP’s) - These processes provide the strategic planning, commitment, leadership, resources,
review and decision-making by top management (see clause 5). These processes generally interact with
all QMS processes at the QMS planning and review level. MOP’s include - business planning; management review;
quality planning; resource planning; communication, etc., whether performed offsite or on-site.
Processes (QMP’s) to document, measure, analyze and improve all processes - These processes provide quality management support to and interact with all QMS
processes. QMP’s include - document control; records control; monitoring and measurement of processes and
product; internal audits; control of nonconforming product; corrective and preventive action; continual
improvement; etc whether performed onsite or off-site. See clause 4 & 8.
· Outsourced Processes (OP’s) - These are
COP’s or SOP’s that are performed by a function or organization outside the ownership or managerial control
of your facility. They may be performed onsite or off-site. These processes include - heat treating;
painting; welding, calibration; testing; sort; HR;