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9000 Store (https://the9000store.com) > ISO

9001:2015 Requirements
(https://the9000store.com/iso-9001-2015-
requirements/) > Clause 04: Context of the
Organization (https://the9000store.com/iso-9001-
2015-requirements/iso-9001-2015-context-of-the-
organization/) > ISO 9001 Processes, Procedures and
Work Instructions

ISO 9001 Processes, Procedures

and Work Instructions

ISO 9001:2015 has relaxed the strict requirement for quality management
documentation. However, in order to satisfy the remaining documentation
requirements and to properly implement the Quality Management System
(QMS), ISO 9001 Processes, Procedures and Work Instructions are typically
still employed.

Section 4.4 of the standard, titled Quality Management System and its Processes
covers the general requirements for work processes. Unfortunately, within
the QMS planning and documentation realm, the terms are often confused.
Below you’ll find definitions of each of these terms with examples and links to
resources to help you improve creation of your ISO 9001:2015
documentation.

p Learn More:
How to Meet QMS Documentation Requirements According to
ISO 9001:2015 (https://the9000store.com/articles/how-to-
document-iso-9001-2015-qms/)

The Relationship Between Processes, Procedures and

Work Instructions
When a company documents its QMS, it is an effective practice to clearly and
concisely identify their processes, procedures and work instructions in order
to explain and control how it meets the requirements of ISO 9001:2015
(https://the9000store.com/iso-9001-2015-requirements/). This begins with a
basic understanding of the hierarchy of these terms and how to efficiently
categorize the workings of a management system within them. Simply put:

Level 0-PROJECT
A process states what needs to be done and why Level 1-Phase
A procedure states how the process needs to be done Level 2-Job PLAN - DO - Check - IMPROVE

A work instruction explains how to carry out the procedure. Level 3- TASK / Activity

Consider a process as a high level, strategic method of control, in effect a

summary of objectives, specifications, and broad resources needed. The
procedure adds more specifics such as responsibilities, specific tools,
methods, and measurement. And a work instruction is a step-by-step
guideline to implement the process and procedure, often segmented in some
way to focus those who are doing the actual work.
PROCEDURE=PLAN - DO - Check - IMPROVE

To control the outcome of a quality management system, more increasingly detailed action
levels are often created in the form of processes, procedures and work instructions. These are
typically to help satisfy a requirement by the quality management standard such as ISO 9001-
2015.

The ISO 9001 Process, Procedure and Work Instruction

hierarchy
Some basic guidelines for remembering the differences between these terms
when documenting your quality management system:

1. Begin with the ISO 9001 processes you are required to document.
(https://the9000store.com/articles/documented-information-required-by-
iso-9001/) The number of processes will typically determine the number
of procedures. While the situation dictates the exact number of
procedures needed to adequately control the desired outcome, it is a
good organizational practice to not create more procedures than
requirements.
2. In most cases, you will create an ISO 9001 procedure for every
process. Many companies write too many procedures when, in fact, they
 should be documenting these directives as more specific work
instructions.
3. When appropriate, create detailed ISO 9001 work instructions for
each task that is needed to support each of your procedures. (A good rule
of thumb is: if the procedure does not give enough guidance for someone
to complete the task, create a work instruction.)

Process
A process is any activity or set of activities that use resources to transform
inputs into outputs. The ISO 9001 standard is based on a process approach
(https://the9000store.com/iso-9001-2015-requirements/iso-9001-2015-
context-of-the-organization/what-is-a-process-approach/). (Establishing
effective and efficient processes that are consistently followed and improved
upon is the basis for most management standards.)

Processes must have defined (and hopefully measurable) objective(s),

input(s), output(s), activities, and resources (https://the9000store.com/iso-
9001-2015-requirements/iso-9001-2015-required-support-resources/). These
key elements should be present when defining a process:

• Inputs/Resources:
• Specified requirements (needs), for example:
• What information do you need to start work?
• Where does that information come from?
• Activities:
• Interrelated or interacting activities that use resources needed to
achieve a specific output
• All of the operations, activities, and sub-processes carried out to
produce the desired result, for example:
• What are the basic jobs carried out in your department?
• Can you explain to me your operations here?
 • Outputs:
• Satisfying requirements (results), for example:
• Who receives the result of your work?
• How do you know if you’ve done your job correctly? (met
objectives)

One way to visualize a process is as a trans-formative “machine” into which both requirements
and resources are fed. The work is done and then received as a satisfactory result. The
effectiveness of the process is measured in its ability to achieve the desired results. The
efficiency of the process is measured in the ratio of results achieved to the resources used.

The ISO 9001 2015 standard (https://the9000store.com/what-are-iso-9000-

standards/buy-standards/) suggests that many types of processes may be
necessary to satisfy its requirements including:

• Operations management processes (https://the9000store.com/iso-

9001-2015-requirements/iso-9001-2015-operational-requirements/)
• Resource management processes (https://the9000store.com/iso-9001-
2015-requirements/iso-9001-2015-operational-requirements/)
• Planning processes (https://the9000store.com/iso-9001-2015-
requirements/iso-2015-requirements-for-qms-planning/)
• Documentation processes (such as those used for direct production or
service provision) (https://the9000store.com/iso-9001-2015-
 requirements/iso-9001-2015-required-support-resources/iso-9001-
2015-detail-documented-information/)

One of the main intents (and results) of employing well-constructed

processes is to unify the working of the organization across vertical functions
(also called “silos”). These may not always have the end goal of customer
satisfaction as an internal priority. By exposing and documenting specific
end-to-end process interaction, a higher order result can be achieved by
proper management techniques (i.e. training, measurement,
incentives/rewards, etc.)

Process Example: Hiring a Contractor The process for hiring a contractor might start with a
request to hire a contractor (input), research into selecting the best contractor to hire
(gathering information about capabilities and collecting quotes), and signing an initial check to
perform a job (output).

Procedure
A procedure is a uniform method that outlines how to perform a process,
such as how you control your suppliers (https://the9000store.com/iso-9001-
2015-requirements/iso-9001-2015-operational-requirements/external-
providers/). It typically contains elements such as:

• Why the procedure is required

• What needs to be accomplished and how it will be executed
• Who performs what action
• Where the inputs come from and where the outputs go
• Any locational requirements (i.e. where an activity is performed)
 • The criteria (requirements (https://the9000store.com/iso-9001-2015-
requirements/)) they must meet
• Tools, information or other resources required
• Terminology, definitions, explanations, etc.

While requirements and supporting processes are often cited in the ISO
9001:2015 standard, the mandate for creating specific procedures has been
removed and replaced with the term “Documented information” (Learn more
about Section 7.5: Documented Information (https://the9000store.com/iso-
9001-2015-requirements/iso-9001-2015-required-support-resources/iso-
9001-2015-detail-documented-information/)). However, that does not lessen
the need for, or effectiveness of, formally specifying procedures. Procedures
are used when there is a definite operation that should be followed on a
consistent basis. (There may be times when a procedure is not necessary. For
example, if it doesn’t matter how new employees are recruited, just that
there is a means for doing so, then a process could be written for that without
a procedure.)

(https://3yn1j14c4twk1bmdg82226en-wpengine.netdna-ssl.com/wp-
content/uploads/2016/08/iso-9001-procedure.pdf)
Procedure Example: Contract Review An example procedure is one that might be important
for mission-critical, high liability industries like aerospace, medical devices or automotive could
outline a formal process used for communicating with customers and reviewing information
from the customer, including customer feedback. Click the above illustration for an example of
how this type of procedure might be constructed using one of our procedure templates.
For example, procedures (https://the9000store.com/compare-iso-9001-2015-
products/iso-9001-2015-documentation-templates/iso-9001-2015-
procedures/) (along with your ISO 9001 quality manual
(https://the9000store.com/compare-iso-9001-2015-products/iso-9001-2015-
documentation-templates/iso-9001-2015-quality-manual-and-
procedures/) and required forms (https://the9000store.com/compare-iso-
9001-2015-products/iso-9001-2015-documentation-templates/iso-9001-2015-
forms/)) often make up the core documentation for the QMS
(https://the9000store.com/what-is-iso-9001-quality-management-system/)
that helps run the system with more conformity, consistency and,
predictability. Your procedures will describe how you operate and control
your business and meet the ISO 9001 requirements
(https://the9000store.com/iso-9001-2015-requirements/) amid fluctuating
conditions such as personnel changes, supplier replacements, updated
customer requirements/expectations, etc. (The 9000 Store provides a
complete set of the required ISO 9001 procedures
(https://the9000store.com/iso-9001-procedures/) that can be used as a
guideline in drafting your specific procedures, an example of which is noted
below.)

Procedure Sample (https://3yn1j14c4twk1bmdg82226en-

wpengine.netdna-ssl.com/wp-content/uploads/2016/08/iso-9001-
procedure.pdf)
A procedure offers a general description of how a company meets a process
requirement but doesn’t include the company-specific details for execution.
These specific directives an employee needs to carry out company tasks are
work instructions (see below)

Work Instruction
A work instruction describes how to perform a task within a process, which
is a more detailed portion of the procedure such as “Completing a PO” or
“Ordering supplies.” The reasons for work instructions are both
organizational and explanatory:

1. There are times more detail (https://3yn1j14c4twk1bmdg82226en-

wpengine.netdna-ssl.com/wp-content/uploads/2016/10/WI-Sample.pdf) is
needed than that which is described in the procedures. Many
organizations include work instructions to detail specific tasks referenced
in a procedure, aid in training (https://the9000store.com/compare-iso-
9001-2015-products/iso-9001-2015-training-products/) and to reduce
mistakes since the step-by-step instructions needed for accomplishing
something may be missing from more generally drafted procedures.
2. However, this functional division between procedure and work
instruction can be a good organizational tool – if there is an advantage to
dividing up procedure(s) into many “sub-procedures” that are related, but
cover different aspects.

A work instruction will often repeat many of the elements of a procedure to

help describe where it fits into the process such as:

• Purpose
• Definitions
• Responsibility
• Requirements
 • Tools and information

But at its core, a work instruction contains the step-by-step detail that is not
advantageous to put into a procedure because it requires such a limited
scope.

(https://3yn1j14c4twk1bmdg82226en-wpengine.netdna-
ssl.com/wp-content/uploads/2016/10/WI-Sample.pdf)
Work Instruction Example: Fabrication A welding-based fabrication assembly set of work
instructions might contain step-by-step instructions for completing a final fabrication
including cutting, drilling and welding the finished part including inspection, inventory
management, etc. Click on the above drawing for an example of how to construct a work
instruction using one of our templates.

As noted above, there is no ISO 9001.2015 mandate for creating work

instructions. However, years of quality management documentation practice
suggests coupling these in the documentation hierarchy can more clearly and
effectively control quality management outcomes.
 (https://3yn1j14c4twk1bmdg82226en-wpengine.netdna-
ssl.com/wp-content/uploads/2016/10/WI-Sample.pdf) Work Instruction
Sample (https://3yn1j14c4twk1bmdg82226en-wpengine.netdna-ssl.com/wp-
content/uploads/2016/10/WI-Sample.pdf)

Please note that certain text from the ISO 9001 standard is only used for
instructional purposes. Standard Stores recognizes and respects the
International Organization for Standardization (ISO) copyright and intellectual
property guidelines (https://www.iso.org/privacy-and-copyright.html).

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8 ISO Registration (https://the9000store.com/step-by-step/step8-iso-9001-

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