ISO 9001 - Clause 7.1.5_ Calibrated Equipment Procedure

Calibrated Equipment Procedure Explained [ISO 9001]
6/20/24, 10:08 AM ISO 9001 - Clause 7.1.5: Calibrated Equipment Procedure
What Is The Calibrated Equipment Procedure?

The calibrated equipment process is considered a crucial procedure in
quality management. It ensures that all measurement and test
instruments used in the design, manufacture, and testing of components,
in-process sub components and finished products or devices are accurate
and effective.
Contents
What is a Calibrated Equipment Procedure?
What’s Included in the Procedure?
Who Is Responsible?
How to Implement the Procedure in 6 Simple Steps
Benefits of a Calibrated Equipment Procedure
Conclusion
Download FREE Procedure
In order to verify product and process conformity, it is often necessary to have

inspection and test equipment that is calibrated. This means that all the measuring
equipment needs to be tested regularly for accuracy and the tolerances checked
against any applicable reference standards or measures to ensure the
measurements taken are accurate.
Read on for more insights into this process, how to execute it, and its benefits.
https://www.iso-9001-checklist.co.uk/calibrated-equipment-procedure.htm 1/13
What Is A Calibrated Equipment Procedure?

A calibrated equipment procedure describes the process that tests and
records the accuracy of all measuring, testing, and monitoring equipment.
It details how calibration activities should be performed, the
responsibilities for each task and any other conditions or limitations to the
calibration.
It is a legal requirement that organizations meet the calibration schcedule for all
measuring equipment. This is to ensure that the integrity of the organization’s work
is within an allowable tolerance range at all times.
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What’s Included in the Calibrated Equipment Procedure?

The calibrated equipment procedure includes details such as the frequency
of calibrations and the people responsible for carrying them out. It also
provides any other information or conditions regarding calibration that
may have been agreed upon when purchasing equipment.
Who Is Responsible for the Calibrated Equipment Procedure?

The quality assurance department is responsible for designing,
implementing, and maintaining the calibrated equipment procedure. They
are also responsible for calibration administration responsibilities as
defined by this document.
In the calibration procedure, the Quality Manager department needs to detail who
will be responsible for carrying out each calibration stage.
As an organization, you should ensure that each section has a person in charge who
is directly accountable for any defective equipment or inaccurate data being used
by the organization.
It is also good practice to identify a calibration supervisor responsible for ensuring

that all required measurements are taken, and equipment is regularly calibrated.
How to Implement a Calibrated Equipment Procedure in 6 Simple Steps

To establish a calibrated equipment procedure, please follow these steps:
1. Identify Which Equipment Needs to Be Tested
The most important part of calibration is to know what you are calibrating. As a rule
of thumb, it’s best if you make a list with the name and description of any
equipment used by your organization.
It is crucial to prioritize the pieces to be tested based on how frequently workers at

your company employ them. Once this is determined, it becomes easier to identify
who needs training for specific devices so errors don’t happen when using them.
2. Identify Inspection and Measurement Processes
Once you have identified what needs to be calibrated, you can then decide whether
this will need to be done as part of an existing process or if there is a separate
procedure in place for it.
For example, if you need to calibrate a pH meter, this could be carried out as part of
routine maintenance.
You may need to establish a separate procedure if you need to test a different piece
of equipment. Each measurement instrument should be traceable through its own
calibration record, which contains:
(limited case) data to test programming performance and error handling to assure
the software and associated equipment meet the specifications.
The test protocol, testing, results, and reviews should be documented, and any
changes to the programming should be formally reviewed and approved before final
acceptance.
Similarly, validated, automated machine tools such as lathes, printed-circuit drills,

and component inserters can be monitored and maintained by conducting a ‘first’
and ‘last-piece’ inspection of representative product lots to assure accuracy.
3. Decide on the Calibration Frequency
You’ll need to decide which frequency calibration should occur, depending on the
equipment and its usage. For example, equipment that operates in high-risk fields
like food safety may need calibration more frequently than other machines.
4. Assign Responsibilities
The selection and training of competent calibration personnel is an important

consideration and the personnel involved with calibration possess the following
qualities:
Technical education and experience in the area of job assignment

Basic knowledge of metrology and calibration concepts
Understanding basic principles of metrology, data processing, and acceptance
requirements
Knowledge of the overall calibration program
Ability to follow maintenance instructions, the use of measurement equipment
and standards
Mental attitude which results in safe, careful, and exacting execution of his or her
duties.
Decide who will be responsible for carrying out each calibration process. It’s crucial
to assign primary responsibility for specific areas within this procedure. Some of it
may be carried out by separate departments. In general, the Quality Manager is
required to:
Select suitable equipment to perform the required measurements with accuracy

and precision
Extend the control of inspection and test equipment to all approved suppliers
where applicable
Ensure inspection and test equipment cannot be used if they are not registered
and calibrated
Ensure inspection and test equipment is calibrated in a suitable environment
Control all measurement, calibration and maintenance activities
All employees and Process Owners are required to:
Check that inspection and test equipment is not damaged and is fit for purpose
Check the calibration status of inspection and test equipment prior to use.
For example, suppose you need a piece of equipment used across your organization
calibrated. In that case, each department should be able to carry out the
5. Decide on the Custody of Calibration Tools
The team must decide how they will store calibration tools. They can choose to
keep them in one designated place with a lock or two separate locations that are
locked and secure at all times, such as the Quality Manager’s office or in close
proximity to the technicians on duty.
As appropriate, ensure that environmental controls are established and maintained

to ensure that monitoring and measuring instruments are calibrated, and used in
conditions that will not adversely affect the accuracy of the measurements.
Consideration must be given to the effects of temperature, humidity, vibration, and

cleanliness when purchasing, using, calibrating, and storing instruments.
This way, only authorized personnel can access these items when needed for
calibrating equipment during operations hours.
Don't Try To Manage It All Alone!

Our Calibrated Equipment Procedure is proven to work.
6. Identify the Relevant Standards
Decide which standards and procedures will be used to ensure correct calibration. It
may help if you check whether the standards require you to include anything
specific in this procedure to meet their requirements. For example, ISO 9001 states
that the Quality Manager should administer the calibration procedure.
Benefits of the Calibrated Equipment Procedure

There are many benefits to having a calibrated equipment procedure in place. One
of the main advantages is that it shows everyone involved how to maintain
accuracy throughout the stages of testing. This means that you will avoid
problems with your product or documentation being inaccurate.
Another benefit is that it makes the calibration process easier to carry out. The
calibration procedure should serve as a reminder of what needs to be done during
each stage and when it’s due. This means that technicians won’t worry about
missing deadlines or forgetting essential processes.
It also gives you an audit trail for any future changes, modifications, or additions
to the equipment. The procedure should be kept up-to-date if there are any
changes. Otherwise, you may run into problems in the event of an audit by the
regulator.
Conclusion
All monitoring and measurement equipment and software performance data is
reviewed by the Quality Manager. Audits of software and equipment maintenance
procedures and records should evaluate the adequacy of safeguards, change
controls, and other controls necessary to maintain software quality and proper
performance of associated equipment.
Related Information You Might Find Useful

7.1.5 Monitoring and Measuring Resources for ISO 9001
9.1 Monitoring Measuring & Analysis Procedure Explained
Journal of Research of the National Institute of Standards and Technology: A
Careful Consideration of the Calibration Concept
Science Direct: Calibration Procedure
Govinfo: Calibration and Related Measurement Services Of The National Bureau
Of Standards
Video — CALIBRATION REQUIREMENTS IN ISO 9001 2015
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Calibrated Equipment Procedure Explained [ISO 9001]

6/20/24, 10:08 AM ISO 9001 - Clause 7.1.5: Calibrated Equipment Procedure

What Is The Calibrated Equipment Procedure?

In order to verify product and process conformity, it is often necessary to have

What Is A Calibrated Equipment Procedure?

Why Reinvent the Wheel?

What’s Included in the Calibrated Equipment Procedure?

Who Is Responsible for the Calibrated Equipment Procedure?

It is also good practice to identify a calibration supervisor responsible for ensuring

How to Implement a Calibrated Equipment Procedure in 6 Simple Steps

1. Identify Which Equipment Needs to Be Tested

It is crucial to prioritize the pieces to be tested based on how frequently workers at

2. Identify Inspection and Measurement Processes

Similarly, validated, automated machine tools such as lathes, printed-circuit drills,

3. Decide on the Calibration Frequency

The selection and training of competent calibration personnel is an important

Technical education and experience in the area of job assignment

Select suitable equipment to perform the required measurements with accuracy

All employees and Process Owners are required to:

5. Decide on the Custody of Calibration Tools

As appropriate, ensure that environmental controls are established and maintained

Consideration must be given to the effects of temperature, humidity, vibration, and

Don't Try To Manage It All Alone!

6. Identify the Relevant Standards

Benefits of the Calibrated Equipment Procedure

Related Information You Might Find Useful

Next ISO 9001 Clause

Each ISO 9001 Clause Explained

Don’t Try to Manage It All Alone!

>> I'm looking for more Procedures

Supplied as fully-editable MS Word or Excel files

Pay by Credit Card, Debit Card, PayPal or Apple Pay.

Please read our Money Back Guarantee.

Are The Templates Suitable For You?

Five Reasons To Choose Our Templates

2. They’ve got everything you need in one simple template

4. Documents use styles to make reformatting and rebranding a breeze

FAQs About Our Templates

Endeavour Technical Limited © 2002 - 2023

Registered in England No. 07175526

Telephone: 0845 054 2886 (UK only)

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