ISO 9001:2015 The process approach ISO/TC 176/SC2/WG23/N156 © ISO 2017 – All rights reserved 1

Purpose of this presentation To explain the process approach in ISO 9001:2015 2

This presentation Developed by the ISO subcommittee responsible for ISO 9001 Available for unrestricted public use Emphasize that the information presented today is based on current work of WG24 and should not be used to make any changes to an organization’s quality management system since it could change. 3

What is the process approach? The systematic management of processes and their interactions to achieve intended results All organizations use processes to: set interrelated or interacting activities transform inputs into outputs  build in checks to meet objectives and promote continuous improvement The process approach integrates processes into a complete system to achieve strategic and operational objectives 4

How do I do it? To use the process approach an organization should: understand and define the processes needed to meet its objectives recognize that the processes are unique to its own context integrate all of the processes and their interactions into a system that utilizes risk-based thinking . 5

Process approach and risk-based thinking The process approach incorporates risk- based thinking Risk-based thinking ensures risk is considered when establishing, implementing and maintaining a management system, each process and each activity 6

The process approach and PDCA Processes can be managed using the PDCA cycle Plan establish objectives and build processes necessary to deliver results Do implement what was planned Check monitor and measure processes and results against the objectives Act take actions to improve results 7

What are the possible benefits? Increases accountability Increases ability to focus and link key processes Improves internal integration of processes Increases awareness of process performance for more consistent results Better use of resources Improves customer confidence in the organization All of these add value for the organization 8

Additional information is available at https://committee. iso 9