ISO 9001:2015

The process approach

ISO/TC 176/SC 2/N1290

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 Purpose of this presentation

To explain the process approach in ISO 9001:2015

ISO/TC 176 SC 2/N1290

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 This presentation

 Developed by the ISO subcommittee responsible

for ISO 9001

 Available for unrestricted public use

ISO/TC 176 SC 2/N1290

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 What is the process approach?

The systematic management of processes and

their interactions to achieve intended results
ISO/TC 176 SC 2/N1290

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 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
ISO/TC 176 SC 2/N1290

The process approach integrates processes

into a complete system to achieve strategic
and operational objectives

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 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
ISO/TC 176 SC 2/N1290

interactions into a system that utilizes risk-

based thinking

.
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 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
ISO/TC 176 SC 2/N1290

process and each activity

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 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
ISO/TC 176 SC 2/N1290

Check monitor and measure processes

and results against the objectives
Act take actions to improve results

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 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
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 Improves customer confidence in the

organization
All of these add value for the organization
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 Additional information is available at

www.iso.org/tc176/sc02/public
ISO/TC 176 SC 2/N1290