The purpose of this section is to explain the process approach used in ISO 9001:2015

The process approach can be applied to any organization and management system, regardless of its type, size and complexity

A set of interrelated or interacting activities that utilize inputs to achieve overdue results

Management systems integrate processes and measures to achieve goals

Process integrates interrelated activities and checks to achieve desired outputs

Define and document detailed plans and controls as needed based on the organization's context

These three concepts together form an integral part of the ISO9001:2015 standard

Risks can have an impact on objectives and results and should be addressed in the management system

Risk-based thinking is applied through a process approach

Risk-based thinking is the basis for achieving QMS effectiveness

Addressing risks and opportunities provides the basis for increasing QMS effectiveness, achieving improved results, and preventing adverse impacts

Positive impacts of risks may provide opportunities, but not all positive impacts provide opportunities

PDCA is a tool for managing processes and systems

The PDCA cycle can be run as a cycle of continuous improvement, and risk-based thinking can be applied at each stage of the cycle.

Focus on critical (high risk) processes and their outputs

To further understand, specify and integrate the processes of interrelated interactions

Treat the management system as a whole and systematically manage the planning, implementation, inspection and improvement of the process

Make better use of resources and enhance responsibility

Continuously achieve policy objectives, expected results and overall performance

A process approach can facilitate the implementation of management systems

Enhance customer satisfaction by meeting customer requirements

Increase trust in the organization