ISO's Process Approach


ISO 9001 2015 section 0.3 expects organizations to adopt a process approach
and section 5.1.1 asks top management to exercise leadership by promoting
an awareness of this approach. But what is it?

The process approach is a management strategy. When managers use a
process approach
, it means that they manage and control the processes that
make up their organizations, the interactions between these processes, and
the inputs and outputs that tie these processes together. It also means that
they manage these process interactions as a system.

When this approach is applied to quality management, it means that they
manage processes and process interactions as a coherent process-based
quality management system


A process is a set of activities that are interrelated or that interact with
one another. Processes use resources to transform inputs into outputs.
They are interconnected because the output from one process often
becomes the input for another process. Since all of this is rather
abstract, we’ll try to make it more concrete with examples.


Since the process approach is now central to ISO 9001, we've tried
to identify the processes that could make up a process-based QMS.
Some of these are listed below.

Of course, our list is not exhaustive. In addition, some of the processes
we have listed overlap. This is difficult to avoid because processes can
be grouped into larger processes and can be subdivided into smaller
processes and because there are many ways to categorize processes.

How you define your processes is entirely up to you. Your organization's
list will probably be much shorter than ours and could be much different.

  • Design process

  • Review process

  • Delivery process

  • Training process

  • Planning process

  • Assembly process

  • Marketing process

  • Validation process

  • Evaluation process

  • Innovation process

  • Monitoring process

  • Production process

  • Purchasing process

  • Leadership process

  • Verification process

  • Traceability process

  • Distribution process

  • Maintenance process

  • Management process

  • Post-delivery process

  • Development process

  • Improvement process

  • Measurement process

  • Manufacturing process

  • Service delivery process

  • Market research process

  • Internal auditing process

  • Communications process

  • Product provision process

  • Document control process

  • Service acceptance process

  • Product acceptance process

  • Management review process

  • Complaints handling process

  • Records management process

  • Resource management process

  • Performance evaluation process

  • Design and development process

  • Information management process

  • Customer communications process


The new standard defines an output as the “result of a process” and then
goes on to list four general types of outputs: services, software, hardware,
and processed materials. However, ISO's very broad definition suggests
that there are many more types of outputs. If an output is the result of a
process, then many kinds of outputs (results) are possible including
not only tangible outputs like products but also intangible ones.

So outputs could include not only services, software, hardware, and
processed materials, but also decisions, directions, instructions, plans,
policies, proposals, solutions, expectations, regulations, requirements,
recommendations, complaints, comments, measurements, and reports.
Clearly, an output could be almost anything.

But what about inputs? Since the output of an upstream process often
becomes the input for a downstream process, outputs and inputs are
really the same thing.


When you think about all the processes that could make up a quality
management system and then think about all the possible input-output
relationships that tie these processes together, you soon realize how big
and complex such a system is. Because of this, you may find it difficult to
create a single map or diagram of your entire process-based quality management system. There are just too many processes and too
many input-output relationships.

For this reason, we suggest that you diagram one process at a time
using a single flowchart on a single page (see diagram below). This
will allow you to specify the most important input-output relationships
without getting buried in complexity. The diagram below shows, in
general terms, how this could be done.

The box in the center is the process you want to diagram. That’s your
focus. Upstream processes provide outputs for the central process and
downstream processes receive inputs from them. Arrows represent inputs
and outputs and the associated text describes them. These arrows also
show that an input-output relationship is sometimes a two-way street.
Sometimes inputs go one way and outputs go the other way.

Process Flowchart


ISO 9001 section 0.3 introduces the concept of a process-based quality
management system
and sections 4 to 10 explain what you need to do
to establish one. But what is it?

A process-based quality management system uses a process approach
to manage and control how its quality policy is implemented and how its
quality objectives are achieved. A process-based QMS is a network of
interrelated and interconnected processes. Each process uses resources
to transform inputs into outputs. Since the output of one process becomes
the input of another process, processes interact and are interrelated by
means of such input-output relationships. These process interactions
create a single integrated process-based QMS.

ISO 9001 asks you to identify the processes that your QMS needs,
to identify their sequence and interaction, to identify required inputs
and expected outputs for each process, to identify process risks and
opportunities, and to assign responsibilities and authorities for each
process. It also expects you to identify the methods needed to manage,
monitor, measure, evaluate, and control each process and to provide the
resources that each process needs. Once you've done all of this you've
defined your process-based QMS. But that's not enough. It also asks
you to address the risks and opportunities that could influence your
organization's process-based QMS or disrupt its operation and to
consider how its context and its interested parties could affect
the results it intends to achieve.

At an abstract level, a process-based QMS can be diagrammed
in the following way. The diagram below shows several processes
interconnected using many lines (and how suppliers and customers fit it).
These lines represent inputs and outputs. All of these interconnected
processes make up a process-based QMS.

Process-based QMS.

ISO 9001 2015 says that you should “maintain documented information
to the extent necessary to support the operation of processes and retain
documented information to the extent necessary to have confidence that
the processes are being carried out as planned”
. In other words, you must
maintain the documents that you need in order to support your processes
and retain the records that you need in order to show that process plans
are actually being followed.

This leaves you with quite a bit of leeway. Essentially, you can provide as
much documentation as you need in order to support your process-based
QMS. While this general requirement allows for quite a bit of flexibility, the
ISO 9001 standard also expects you to establish quite a few very specific
documents and records (most of these are discussed in section 7.5).

We suggest that you use flowcharts to give people a view of the big
picture and develop more detailed procedures to show them how
process activities should be carried out. However, this is only our
recommendation. It's not an ISO 9001 requirement.


PDCA stands for Plan-Do-Check-Act. ISO used the PDCA model
to organize the new ISO 9001 standard in the following way:

  • Plan (sections 4, 5, 6, 7)
  • Do (section 8)
  • Check (section 9)
  • Act (section 10)

ISO 9001 also recommends that you use the PDCA model to
establish your organization's processes. It suggests that you:

  • Plan each process
  • Operate each process
  • Evaluate each process
  • Improve each process

It also suggests that you use the PDCA approach to establish
your organization's process-based QMS. It suggests that you:

  • Plan your process-based QMS
  • Operate your process-based QMS
  • Evaluate your process-based QMS
  • Improve your process-based QMS

MORE ISO 9001 2015 PAGES

ISO 9001 2015 Introduction

Quality Management Principles

Outline of ISO 9001 2015 Standard

Overview of ISO 9001 2015 Standard

ISO 9001 2015 versus ISO 9001 2008

ISO 9001 2015 Internal Audit Program

Plain English ISO 9000 2015 Definitions

ISO 9001 2015 Translated into Plain English

Plain English Quality Management Checklist

Plain English ISO 9001 2015 Gap Analysis Tool


ISO 9004 QMS Library

ISO 19011 Auditing Library

AS9100D Aerospace QMS Library

ISO 31000 Risk Management Library

ISO 13485 Medical Device QMS Library

ISO 20000 Service Management Library

ISO 14001 Environmental Management Library

ISO 90003 Software Quality Management Library

ISO 22301 Business Continuity Management Library

ISO 28000 Supply Chain Security Management Library

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 Updated on August 24, 2017. First published on November 25, 2014.

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