This document discusses the process approach in ISO 9001:2015. It defines the process approach as integrating processes into a complete system to achieve strategic and operational objectives. An organization should understand, define, and integrate its unique processes and their interactions. The process approach incorporates risk-based thinking to ensure risks are considered when establishing, implementing, and maintaining processes. Processes can be managed using the PDCA (Plan-Do-Check-Act) cycle. Benefits of the process approach include increased accountability, focus, integration, and consistency as well as better resource use and customer confidence.

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

2. To explain the process approach in ISO 9001:2015
Purpose of this presentation
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3. This presentation
 Developed by the ISO subcommittee responsible
for ISO 9001
 Available for unrestricted public use
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4. 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
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The systematic management of processes and
their interactions to achieve intended results

5. 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
.
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6. 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
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7. The process approach and PDCA
Processes can be managed using the PDCA
cycle
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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

8. 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
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9. Additional information is available at
https://committee.iso.org/tc176sc2
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