What is the process approach?
All organizations use processes to achieve their objectives.
• 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 includes establishing the organization’s processes to operate as an
integrated and complete system.
• The management system integrates processes and measures to meet objectives
• Processes define interrelated activities and checks, to deliver intended outputs
• Detailed planning and controls can be defined and documented as needed, depending
on the organization’s context.
Risk‐based thinking, PDCA and the process approach
These three concepts together form an integral part of the ISO 9001:2015 standard. Risks that may
impact on objectives and results must be addressed by the management system. Risk‐based thinking
is used throughout the process approach to:
• Decide how risk (positive or negative) is addressed in establishing the processes to
improve process outputs and prevent undesirable results
• Define the extent of process planning and controls needed (based on risk)
• improve the effectiveness of the quality management system
• maintain and manage a system that inherently addresses risk and meets objectives
PDCA is a tool that can be used to manage processes and systems. PDCA stands for:
P Plan: set the objectives of the system and processes to deliver results (“What to do”
and “how to do it”)
D Do: implement and control what was planned
C Check: monitor and measure processes and results against policies, objectives and
requirements and report results
A Act: take actions to improve the performance of processes
PDCA operates as a cycle of continual improvement, with risk‐based thinking at each stage.
What are the possible benefits?
• A focus on the more important (“high‐risk”) processes and their outputs
• improved understanding, definition and integration of interdependent processes
• systematic management of planning, implementation, checks and improvement of processes and the management system as a whole.
• better use of resources and increased accountability
• more consistent achievement of the policies and objectives, intended results and overall performance
• process approach can facilitate the implementation of any management system
• enhanced customer satisfaction by meeting customer requirements
• enhanced confidence in the organization.