1. ISO 9001:2015 The process approach

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

3. 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

4. What is the process approach?
The systematic management of processes and their interactions to achieve intended results 4

5. What is the process approach?
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 5

6. 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 . 6

7. 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 7

8. The process approach and PDCA
Processes can be managed using the PDCA cycle
Plan
set 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 8

9. 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 9

10. Additional information is available at www.iso.org/tc176/sc02/public