Employing the Process Approach

The ISO 9001:2015 Standard employs the process approach in order to enable the organization to
effectively plan its processes and their interactions (see clause 0.1 of the Standard—General). How
effective? The effectiveness of an organization depends much on its ability to perform several
interconnected activities simultaneously in order to achieve intended results—the expectations of the
interested parties.
These relations should be managed, prioritized, and controlled. The ISO 9001 Standard requires adopting
a system of processes within the organization. This system of processes requires the application and
implementation of a method for the identification of processes in the organization, the definition of their
sequences and interrelations, and the application of their controls. The goal here is to develop and plan
processes and methods for the realization of products or services. The ISO 9001 Standard regards it as a
critical element of product realization.
24 ISO 9001:2015—A Complete Guide to Quality Management Systems
Terms and Definitions
Before we start to unveil the requirements of clause 4.4 and their implementation, it is important to know
some terms and definitions:
• Process—A set of interrelated or interacting activities that convert inputs into outputs and accomplish a specific
organizational goal. These activities require allocation of resources such as people and materials.
• Scope of a process—Scope of the process defines precisely where a process starts and
ends, what its related inputs and outputs are, and which activities are included and
excluded.
• Supplier of a process—The deliverer of inputs to a process (data, information, goods,
or services). Supplier may be an external supplier that delivers, for instance, goods
or material or an internal supplier—an organizational unit that delivers inputs to a
process.
• Customer of a process—The receiver of the outputs of a process (data, information,
goods, or services). The customer defines what outputs are expected according
to its needs. Customers may be external customers, end customers, or internal
customers.
• Inputs—Specified requirements needed to be put into a process in order to start the
process. The inputs will be processed by a process or activity.
• Output—Specified expected or intended result of a process.
• Risk—Combination of the probability of occurrence of not fulfilling process specifications or customer
requirements.
• Monitoring of processes—A continuous, sequential, and periodic examination of
processes and its outputs.
• Measurement of processes—Determining a physical measurement of processes and
their outputs based on data.
• Process owner—An organizational function responsible for a process or
subprocesses.
Applying the Process Approach
Process approach or system approach refers to the act of implementing a method or rules that analyze,
identify, manage, and measure the processes of the organization. These processes are necessary for the
operation of the QMS and the realization of the product. The fundamental goal is to create standardization
of processes in the organization and to ensure that persons or different organizational units in the
organization work in a unified way. The objectives of the process approach are as follows:
• Creating awareness and understanding in the organization regarding responsibility
for managing activities
• Implementing a method for the identification and planning of activities needed for
the operation of the QMS
• Defining the sequences between processes
• Promoting a smooth and transparent flow of operations in the workflow
Context of the Organization 25
• Identifying and ensuring the interactions between processes, that is, activities in the
organization
• Ensuring accurate delivery of inputs to processes
• Monitoring and controlling activities of the QMS
• Ensuring delivery of the right process outputs
• Ensuring achievement of intended results or process objectives
• Enhancing satisfaction of process customers
• Creating basis and environment for addressing risks and preventing errors
• Creating basis and environment for the planning, implementation, and analysis of
improvements (PDCA cycle)