Processes, Procedures

and Work Instructions

Although ISO 9001-2015 has relaxed the strict requirement for quality management
documentation, to satisfy the remaining documentation requirements, and (often more
important), to properly implement the quality management system (QMS), Processes,
Procedures and Work Instructions are typically still employed. Unfortunately, within
the QMS planning and documentation realm, the terms 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.
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. 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:
A process states what needs to be done and why
A procedure states how the process needs to be done
A work instruction explains how to carry out the procedure .
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.
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 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 processes you are required to document. 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 a 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 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 uses resources to transform inputs into
outputs can be considered a process. The ISO 9001 standard is based on 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. 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 it 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:
 Satisfied 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 suggests that many types of processes may be necessary
to satisfy its requirements including:
 Operations management processes
 Resource management processes
 Planning processes
 Documentation processes (such as those used for direct production or service
provision)
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”) that 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. 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) 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.” 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.)
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 (along with your ISO 9001 quality manual and required forms)
often make up the core documentation for the QMS 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 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 that can be used as a guideline in drafting your
specific procedures, an example of which is noted below.)

Procedure Sample

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 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 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.

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.

Work Instruction Sample

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.