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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.
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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.
Product: Documentation Templates
(https://the9000store.com/compare-iso-9001-2015-products/iso-
9001-2015-documentation-templates/)
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.)
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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.
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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:
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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.)
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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 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/compare-iso-9001-
2015-products/iso-9001-2015-documentation-templates/iso-9001-2015-
procedures/) that can be used as a guideline in drafting your specific procedures,
an example of which is noted 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:
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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
(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.
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
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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).
(https://the9000store.com/compare-iso-9001-2015-
products/iso-9001-2015-certification-packages/iso-9001-2015-certification-package/)
Our All-in-One Certification Package is a proven, efficient system. It gives you all you
need to prepare for registration – in one simple to use package.
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VIEW DETAILS
4 Training (https://the9000store.com/step-by-step/step4-iso-9001-training/)
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9001/)
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Gap Analysis Service
A consultant can save you time by performing a gap analysis for you.
They are well versed in all of the ISO 9001:2015 requirements, and will
help you focus in on the areas of your organization that need
improvement to achieve certification. (Remote Analysis also available.)
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