Calibration Questions
What is your standard turnaround time for calibration?
Do you offer expedited calibration services?
What are your calibration expedite fees?
Do you offer pickup and delivery services?
What if my instrument cannot be calibrated?
Can you provide me a recommended calibration interval for my instrument?
Is my calibration the same regardless of which of your labs it is performed in?
Do you provide accredited reference level calibrations?
What are the different levels of Calibration you offer?
Where are your calibration laboratories located?
Do all of your facilities have the same capabilities?
Are you ISO 17025 accredited?
What is the difference between accrediting bodies such as NVLAP, A2LA, etc.?
What levels of calibration are accredited?Can you provide calibrations calculated at 95%
confidence K-=2?
What type of instruments do you calibrate?
Do you have a calibration management program?
Can I specify points for my calibration?
What is your calibration and/or repair warranty policy?
Is my calibration warrantied over the length of my calibration interval?
If I change my calibration interval to two years instead of one year does my price change?
Do you offer a NIST traceable calibration? All I see is accredited calibration.
Aren't NIST-Traceable and Accredited calibrations the same thing?
Why should I use a 17025 provider when all I need is a NIST cal?
Are you traceable to the National Institute of Standards and Technology (NIST)?
What are "uncertainties" and why would I need them?
Is "as found/as left" data necessary?
What makes you different from any other calibration provider?
Is the use of an accredited laboratory sufficient to satisfy the need for accredited calibrations?
What is the difference between an ISO17025 calibration and a commercial calibration?
All I need is a cal sticker what difference does it make who I use?
Do I need to have my equipment calibrated regularly?
Do I need documented uncertainties with every accredited calibration?
Do you have a pricing list/chart for the equipment you do have the capabilities to calibrate?
What is your standard turnaround time for calibration? Our standard turnaround for most
instruments is five business days after receipt of your instrument.Some specialty instruments
and disciplines may take longer. You will get a notification of yourestimated ship date upon
receipt of your instrument.
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Do you offer expedited calibration service? We can provide two-day expedited service on
most instruments after receipt in the lab. Expedite requests are on a first come, first served
basis and is dependent on the lab and the discipline. Some calibrations cannot be expedited due
to the nature of the instrument.
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What are your calibration expedite fees? Expedite fees vary depending on the instrument.
Please consult with our sales representative for exact pricing.
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Do you offer pickup and delivery service? Yes we do offer pickup and delivery services within
a 100 mile radius around most of our labs.Please contact our sales representatives for specific
information about availability.
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What if my instrument cannot be calibrated? If your instrument cannot be calibrated due to
an instrument failure, you will be notified to determine how you would like to pr oceed. A number
of different options may be available including: repair of the instrument by us at our Houston
Repair Center, repair by the OEM if applicable, or we can provide a quote for a replacement
instrument.
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Can you provide me a recommended calibration interval for my instrument? No, we cannot
recommend a calibration interval. This would be a conflict of interest for us. You must choose a
calibration interval based upon your company's quality policy and the performance of the
instrument over time.There are a number of factors that need to be considered when
determining your calibration interval. We wouldbe happy to provide you with assistance if
needed.
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Is my calibration the same regardless of which of your labs it is performed in? Yes, we
use a proprietary, centralized calibration database which is shared amongst all of our
laboratoriesusing the same datasheets. The only variation may be in the standard that is used in
the calibration. Click to see more information on our company calibration processes.
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Do you provide accredited reference level calibrations? Yes, we offer accredited reference
level calibrations in a variety of disciplines including:electrical, temperature, mass, and pressure.
Contact your Sales Representative or visit:http://www.transcat.com/calibration-services/service-
types/lab-capabilities/
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What are the different levels of Calibration you offer? We offer three levels of calibration
service: Certificate of Calibration, Certificate of Calibration with Data,and Certificate of
Calibration with Data and Uncertainties.Click here to see detailed information on each of the
service levels available.
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Where are your calibration laboratories located? We have laboratories located throughout
the US, Canada, and Puerto Rico.Please visit the following page for exact locations.
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Do all of your facilities have the same capabilities? All of our labs have similar general
purpose capabilities. Some may vary slightly depending on the assets being used. Some of our
labs have specific capabilities or can perform reference level calibrations. For specific details,
please consult our Global Scope of Accreditation.
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Are you ISO 17025 accredited? Yes, all of our labs have been audited for compliance and
accreditation to ISO/IEC 17025:2005 and ANSI/NCSL Z540-1994-1. The calibration system and
related activities comply with the requirements of ISO 9001:2008, ISO/IEC 17025, MIL STD
45662A, ANSI/NCSL Z540-1, and ISO 10012, as applicable. The reporting of defects and
noncompliance per 10CFR21 is covered by documented procedures. The quality system meets
the applicable requirements of 10CFR50 Appendix B and ASME NQA-1 Basic and supplements,
as applicable. For more information, please feel free to review our Quality Manual.
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What is the difference between accrediting bodies such as NVLAP, A2LA, etc.? The main
difference between NVLAP and A2LA is that NVLAP is directly affiliated with NISTwhile A2LA
and some other accrediting bodies are private entities.
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What levels of calibration are accredited? All of our levels of calibration are accredited by the
individual lab's scope of accreditation, however per ILAC P14,you must have the measurement
uncertainties of the calibration in order to pass traceability on to your measurements.For more
information, please view our white papers at:http://www.transcat.com/calibration-
resources/white-papers/
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Can you provide calibrations calculated at 95% confidence K-=2? Yes all our calibrations
are calculated at a 95% confidence level.
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What type of instruments do you calibrate? We calibrate a wide variety of instruments across
a number of disciplines including electrical, temperature, pressure, dimensional,
humidity, torque, flow, reference level, and many more. For a complete overview of our
capabilities, please visit: http://www.transcat.com/calibration-services/service-types/lab-
capabilities/
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Do you have a calibration management program? Yes, we have a comprehensive calibration
and asset management program called C3. C3 stands forCost, Control and Compliance. For
more information about C3, please visit this page and view our
demo: http://www.transcat.com/calibration-services/quality/c3-asset-management/
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Can I specify points for my calibration? Yes you can specify which points are used for your
calibration. There may be an additional charge depending on the points requested and the
discipline of the calibration. The calibration may also be considered a "limited calibration" if the
test points requested do not test the entire function/range of the instrument.
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What is your calibration and/or repair warranty policy? Transcat warrants all calibration or
repairs made to be free from defects in material or workmanship under normaluse and service
for a period of ninety (90) days from the date of shipment to the Customer.Please see our terms
and conditions.
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Is my calibration warrantied over the length of my calibration interval? No, an instrument's
calibration is not warrantied over the length of the calibration intervals. There are a number a
reasons an instrument can drift over time that would affect its performance including instrument
failure, mishandling, environmental conditions, improper use, etc.
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If I change my calibration interval to two years instead of one year does my price
change? Your specified calibration interval has no bearing on the price of your calibration.Each
customer sets their own calibration intervals.
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Do you offer a NIST traceable calibration? All I see is accredited calibration. Generally, all
of our calibrations are traceable to a higher authority such as NIST. NIST is a N ational
Measurement Institute (NMI), but is not the only NMI capable of providing traceability. Most
countries have their own national body, Canada's NMI is the NRC, Germany's NMI is PTB, and
the NMI for the United Kingdom is NPL, to name a few. Even when Transcat uses Intrinsic
Standards (physical properties that are inherent) we will still correlate those values witha higher
or equal body such as NIST, NRC, or PTB, which effectively provides traceability.
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Aren't NIST-Traceable and Accredited calibrations the same thing? Accreditation is a
process where a higher authority (Accreditation Body or AB) reviews and validates all calibration
processes of the respective calibration provider. This includes their Management processes and
Technical processes (i.e. traceability to a higher authority) on a regular basis. This process is
conducted at each respective laboratory and generally takes two to four days, dependent on the
size of the lab. Generally this is a rigorous process but varies somewhat depending on the AB.
After review and validation that the respective processes are adequate to provide measurements
within the respective Lab's published uncertainties. NIST-Traceability or a statement of
traceabilityto a higher body doesn't include validation of processes (Accreditation) by an
independent body.
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Why should I use a 17025 provider when all I need is a NIST cal? Because of the validation
processes as stated above.
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Are you traceable to the National Institute of Standards and Technology (NIST)? For most
parameters, yes, but we use other NMI's for many parameters as well.
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What are "uncertainties" and why would I need them? Basically uncertainties define how
well a lab can perform a respective measurement, the lower the uncertainty the better the
measurement. Uncertainties are all inclusive of respective processes to include traceability
components. Please click here to see our white papers.
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Is "as found/as left" data necessary? Measurement data isn't absolutely required but it is
highly recommended for most quality programs. This data enables the user to determine where
within its respective tolerance requirements the instrument was found and was returned to the
customer. This is especially important when the unit is found out of tolerance. One of the most
important usesof this data is that the user of the Test and Measurement Equipment (T&ME) can
evaluate the impact that Out of Tolerance (OOT) readings had on the processes where the
respective instrument were used. Another very important use of this data is to evaluate (Trend)
how the respective T&ME is performing and shorten or lengthen the calibration interval of that
instrument based on this data.
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What makes you different from any other calibration provider? Transcat invests significantly
in its quality and operations departments to ensure our systems and processes are correct. This
includes a robust technical & quality team that develop calibration processes and verify those
processes on a regular basis. These processes are employed across all of our laboratories so
every lab is standardized, they all operate the same. Generally, regardless of which l ab a
customer sends his T&ME to the calibration will be the same. Transcat's primary Accreditation
Body (AB) National Voluntary Laboratory Accreditation Program (NVLAP) is an extremely robust,
high quality AB and is an extension of NIST.
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Is the use of an accredited laboratory sufficient to satisfy the need for accredited
calibrations? If a lab doesn't offer accreditation on one or multiple points of a calibration it could
raise a caution flag. As a customer you may want to ask why that/those parameters are not
accredited. If the reason is that the calibration providers processes do not meet the rigors
needed to meet accreditation requirements for that/those parameters, including traceability, then
as a customer you should be wary. If the reason is that the cal provider was between
accreditation visits when the parameter was developed and that they plan to have that/thos e
parameters accredited during their next accreditation cycle, which often happens, this would
probably be acceptable.
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What is the difference between an ISO17025 calibration and a commercial calibration? In
our opinion a calibration is a calibration regardless if it's a commercial calibration or an
accredited calibration. Our processes and data supplied are the same for all calibrations. If a
calibration provider offers a commercial cal that is different than what they offer for an accredited
cal does that mean the commercial cal is less adequate?
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All I need is a cal sticker what difference does it make who I use? If you are making
measurements it's important that you have confidence that those measurements are correct.If
not what's the point in measuring? As it is important for the M&TE to measure correctly it is also
important that the calibration provider that verifies/calibrates the M&TE have the systems in
place that ensures the respective calibration is correct. As stated above, Transcat has robust
technical and quality processes that insure the calibration is correct.
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Do I need to have my equipment calibrated regularly? Almost always, but the frequency of
recalibration varies depending on the M&TE. Usually this interval is defined by the OEM but can
be adjusted based on the stability of the respective M&TE.(See response for: Is as found/as left
data necessary?)
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Do I need documented uncertainties with every accredited calibration? Per
the International Laboratory Accreditation Cooperation (ILAC) P14 you must have documented
uncertainties to continue traceability. What this statement means is if you intend to calibrate
other instruments with the respective M&TE or if you intend to develop your own uncertainties of
your measurement process using the respective M&TE, you must have documented
uncertainties.
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Do you have a pricing list/chart for the equipment you do have the capabilities to
calibrate? Due to the vast number of instruments we calibrate, as well as the many variations of
these instruments, it is not possible to provide a complete price list. You can submit your list of
instruments to your Sales Representative and they would be happy to provide you a detailed
price quote. You can also submit your request here or Contact Us for more information
https://calibrationawareness.com/understanding-iso-9001-calibration-requirements-
calibration-clauses-explained
Understanding ISO 9001
Calibration Requirements -
Calibration Clauses
Explained
Almost all industries used monitoring and measuring equipment to manufacture products or
support services, it is required that this equipment must be calibrated in order to ensure that
the intended product specification is achieved. In short, quality is maintained when
calibration is performed.
ISO 9001 is the quality management system designed for manufacturers (producers of
products) or service providers. There are other more specific standards for specialized
industries like automotive, pharmaceuticals or Oil and Gas but ISO 9001 is still integrated
with them.
For a calibration process to be properly implemented, there should be in-house calibration
management that we should follow.
What is calibration and why do we need calibration? Visit my other post in this link
>> calibration awareness
This calibration management is guided by ISO 9001: 2015 Standards which has dedicated
clauses that detail the requirements needed for proper implementation.
In this article, I will share with you:
1. The related clauses of ISO 9001 that are focused mainly on calibration requirements.
2. ISO 9001 Calibration procedure – The content of a calibration procedure
ISO 9001 Calibration Requirements
What are the Calibration requirements of ISO 9001? Below are the related clauses where
calibration requirements are provided. These clauses that I listed here are the clauses with
calibration requirements that are directly affecting the calibration results, these are:
1. Clause 7.1.2 People
2. Clause 7.1.4 Environment for the operation of processes
3. Clause 7.1.5.1 General monitoring and measuring requirements
4. Clause 7.1.5.2 Measurement traceability
5. Clause 7.2 Competence
6.
evaluation
Clause 9.1.1 General requirements for monitoring, measurement, analysis, and
These are the calibration requirements as per my experience, you may include other
clauses you know that are directly affecting the calibration results.
Clause 7.1.4 Environment for the operation of processes
This clause requires the monitoring and control of the environment for the correct
performance of calibration. Same with ISO 17025 requirements, environmental conditions
that influence the final output of calibration results should be monitored and controlled.
Some examples of environmental conditions that we need to monitor and control are:
1. Temperature
2. Humidity
3. Vibrations
4. Dust
5. Proper lighting
6. Airflow
Not all listed above needs to be controlled simultaneously inside a lab. This depends on the
criticality and the effect it can contribute to the calibration performed.
But mostly, the two environmental conditions that are always controlled are temperature
and humidity because almost all instruments require it for proper functioning, it is detailed in
their specifications.
Clause 7.1.5. monitoring and measuring requirements
Instruments that we use to perform measurements are considered monitoring and
measuring instruments.
“It is either we perform a measurement to monitor and control a process or we perform
measurement for verification of the output of our process.”
With this in mind, all the instruments that are used for monitoring and measurement should
be controlled.
The control provided are:
1. The instrument to be used should be suitable. Suitable means it covers the range
and accuracy requirement. For every monitoring and measuring instrument we use,
we should ensure that the usable range can be covered and as much as possible, it
has higher accuracy than the process to be measured. Recommended is to maintain
the Test Uncertainty Ratio (TUR) of 4:1.
Maintaining a TUR of atleast 4:1 will ensure that our standards are still in confidence
even it encounters a drift that we cannot immediately detect.
Another best approach is to use a standard with small measurement uncertianty
results, this can be seen in its calibration report. Smaller measurement uncertainty
means more accurate output of our calibrators.
calibration label and seal
2. Every monitoring and measuring instrument should be maintained to ensure confidence
while using or within its calibration interval. Maintained means:
a. Properly monitored for its statuses like locations, labels, and calibration due dates.
b. Preventive maintenance is performed
c. Intermediate check is performed – a verification process.
Records of Implementation of the above requirements should be maintained that can be
used as evidence of implementation during audits.
Check out this link to read more about monitoring and measurement >> Applications of
Monitoring and Measurements
Clause 7.1.5.2 Measurement traceability
We should ensure measurement traceability for every monitoring and measuring instrument
used. It is a requirement that is a must to follow to ensure confidence in the validity of
measurement results.
Let us define first Traceability. As per VIM 3 clause 2.41, Traceability or Metrological
Traceability is “Property of a measurement result whereby the result can be related to a
reference through a documented unbroken chain of calibrations, each contributing to the
measurement uncertainty”.
There are 2 ways where we can implement Measurement Traceability requirements, these
are:
1. Establishing traceability
2. Maintaining traceability
Establishing Traceability
Traceability Chain with pyramid
In establishing traceability under ISO 9001, we use clause 7.1.5.2 stating that,
The definition above is about establishing Traceability, wherein the measurement result of
our instruments should be linked or connected through an unbroken chain of calibrations all
the way to SI.
(a) “all monitoring and measuring instruments shall be calibrated or verified, or both, at
specified intervals, or prior to use, against measurement standards traceable to
international or national measurement standards”.
The
to use,
traceability
by a higher
of your
laboratory
instruments
that iswill
linked
be established
to international
whenstandards
calibrated,
or SI.
verified or both prior
How is traceability being established during calibration? One objective answer to this is
through the “measurement uncertainty” results. After calibration from a higher lab, a link is
connected once there is a Measurement Uncertainty results reported in the calibration
certificate. This is the value in the traceability pyramid that is being passed on from the top
to the bottom. Read more at this link >> The Deeper Meaning of Traceability in Calibration
To ensure traceability, such laboratories should be accredited under ISO 17025.
Traceability can also be established by using a Certified Reference Material or CRM
provided by a reputable source.
Maintaining Traceability
After the successful establishment of traceability, the most challenging part is now to
maintain traceability.
Activities that support the maintenance of traceability are the following which are the 2
remaining sub-clauses of 7.1.5.2. these are:
(b) Identified in order to determine their status
Identification through labeling and coding of measuring instruments in order to monitor their
status. Labels include a clear detail of its calibration due date, date of calibration, and who
performs the calibration.
Status means their present location, calibration interval, calibration condition (within
tolerance), and specific records that detail their performance and specifications.
(c) safeguarded from adjustments, damage, or deterioration that would invalidate the
calibration status and subsequent measurement results.
Safeguarded from adjustments using void seals and safeguarded from damage or
deterioration by implementing procedures for proper handling, transport, and storage while
it is being used for measurement and/or calibration.
UUT with equipment ID and void seal
When measuring
actions shall be taken
equipment
like: is found to be unfit for its intended purpose, appropriate
1. recalibration,
2. adjustment and verification
3. adjustment of the calibration interval
4. proper disposition – scrap or reject
Read more about the deeper meaning of traceability in this link >> Traceability
Clause 7.2 Competence
As defined by ISO 19011 competence is: “demonstrated personal attributes and
demonstrated ability to apply knowledge and skills “.
Clause 7.2 and 7.1.2, which is about People are related to each other. ISO 9001 clause
7.1.2 requires that “The organization shall determine and provide the persons necessary for
the effective implementation of its quality management system and for the operation and
control of its processes.”
In relation to calibration, the People, which are the personnel involved in performing
calibration should be competent or have the necessary competency.
Personnel Competency is one of the main requirements that we must meet. All factors that
influence the quality of calibration performed depend on the knowledge, skills, experience,
and education of Personnel.
You may have a high-end calibrator, a good calibration procedure, and a well-equipped
facility but the person in charge is not suitable for the calibration activity performed, then the
calibration results may be invalidated.
To be competent means:
1. Has the necessary competence requirements such as appropriate education, training,
or experience;
2. Pass the competency evaluation
3. Authorized to perform important laboratory activities
4. Monitored competency and continued education
All the records and recorded information resulting from this process should be maintained
and used as evidence of competency.
I discussed more ‘personnel competency’ in my other post here >> Personnel Competency
Clause 9.1.1 General requirements for monitoring, measurement, analysis, and
evaluation
This clause is composed of many processes or activities that involve monitoring,
measurement analysis, and evaluation. But in this article, we will just focus on the
requirements related to calibration.
In these requirements, we need to determine:
1. What needs to be monitored and measured.
We need to monitor our measuring instruments and measure or perform verification on the
measurement results or displayed output.
We need to monitor measuring resources to be able to control and properly maintained and
ensure the validity of results every time they are used. Monitoring is easily implemented by
having a master list of all the measuring instruments and standards that details their
important information and specifications including their calibration records.
2. The methods for monitoring, measurement, analysis, and evaluation needed to
ensure valid results;
We need to have a procedure for quality control like performing recalibration, intermediate
check, calibration interval adjustment, or verification and validation to ensure traceability
and valid results are maintained. We can use statistical techniques like control charts or a
simple checklist and tables to analyze and evaluate each performance.
3. When the monitoring and measuring shall be performed;
All the methods or procedures for quality control stated in number 2 (above) should have a
specific schedule of implementation. For example, for Temperature and humidity, a
schedule of 3 times a day is given. Another example is the Intermediate check which is
performed every 3 months alongside preventive maintenance. This will ensure regular or
periodic implementation to maintain the quality and confidence of results.
4. When the results from monitoring and measurement shall be analyzed and evaluated.
Every time we implement the quality control procedures of number 3 above, we can gather
the data then immediately subject to analysis and evaluation.
Another example of analyzing and evaluating measurement results is during the receipt of a
newly issued calibration certificate. There should be a process in place on how to review or
evaluate a calibration report.
Mostly, we are looking for any out-of-specification condition or a trend that shows us
something is wrong or will become an issue in the future. If any issues were found,
corrective or preventive action will be issued and proper action is taken.
Other Calibration Requirements
The clauses that I identified above are the main clauses that have an impact on the
calibration results and are directly calibration implementation requirements in my
understanding. There are other clauses that are still calibration-related but do not directly
impact the results of calibration and are mostly under Quality.
Such as:
1. Internal audit – auditing the calibration process
2. Document and records control – controlling documents and records like calibration
procedures, calibration certificates and datasheets.
3. Risk and opportunities – Identifying risk and opportunities from calibration activities to
improve and mitigate any issues found.
4. Improvements – performing improvement activities to further improve the calibration
processes like equipment upgrades, regular training, or monthly meetings.
5. Complaints or Customer survey – customers are the users of instruments, it is
important to document their concerns for improvements.
Overall, the requirements of ISO 9001 will provide a complete implementation to support the
proper operation of an Internal Calibration Laboratory. But we need to have a deeper
understanding of all the calibration requirements in order to properly manage a calibration
Lab.
ISO 9001 standards do not provide the exact Instruction to manage a calibration lab, just a
general requirement. If you want in-depth Calibration Laboratory management guidelines,
you need to be familiarized with ISO 17025 Standards, this is the main standards for
calibration and testing lab, specifically if you want to provide services to other clients or
industries.
Do you want a guide in implementing In-house Calibration? Check out my other post
here>> Elements In Implementing an Internal Calibration Laboratory
ISO 9001 Calibration Procedure
I will share here the ISO 9001 calibration procedure, also known as the calibration method,
which is referring to an Internal calibration procedure used to execute the actual calibration
of instruments for in-house or internal calibration lab.
I have seen a number of calibration procedures from different calibration labs and I can tell
you that every company has different formats.
There are no exact requirements for the formats of a calibration procedure that I am aware
of, most available formats are just recommendations. I believe it is based on the company
policy and the experience or expertise of the Calibration engineer who created the
calibration procedure.
There are some instances that a calibration procedure for ISO 9001 is very simple, where it
is integrated into the procedures of preventive maintenance or equipment operation manual.
There are also calibration procedures that are ‘generic’, which means it is applicable for
many types of instruments.
But regardless of either ISO 9001 or ISO 17025 calibration procedure, before we will use it,
we must consider the important calibration procedure requirements, these should be:
1. Verified or validated before use.
2. It has traceability; there is a reference to where it came from and who created it.
3. Approved before use
4. Up to date – the latest version is used
5. Controlled- included in Document and Records Control
Content of a Calibration Procedure
If you are planning to create or prepare an ISO 9001 calibration procedure or calibration
methods, the following are the calibration procedure content, as a minimum, that I am
aware of.
These can be used as content of a calibration procedure template.
These are:
1. Purpose – state the reason why we have the calibration procedure
2. Scope–to what instruments does the procedure applies including the range if necessary.
(sometimes purpose and scope are the same).
3. Terminology – includes here the terms or acronyms used in the procedure that we need
to define.
4. Safety–detailed here the possible safety hazards and their avoidance including any
safety documents that need to follow or accomplish before performing calibration.
5. Reference Standard Used–describes all the reference equipment used for calibration for
traceability and accuracy evaluation.
6. Other Materials/Tools – includes all other supporting materials or tools to perform the
calibration/test activity.
7. Reference Document Use–these are the reference documents where the procedure
was based during write-up or drafting. Also, a reference to determine the traceability of the
procedure used.
8. Initial requirements/preparation– as the term implies, any requirements or
prerequisites before initiating the calibration/test process. A preparation in order to achieve
the best results.
9. Calibration Procedure -Main Steps of procedure Execution, the step-by-step
instructions in performing the actual calibration. This includes any calculations or photos to
easily describe and understand the procedure.
10. Acceptance Criteria–detailed here is the tolerance limit that needs to be met for
verification purposes after performing the calibration.
11. Storage and Handling – describe here where to put the instruments and how it is
handled after calibration.
Additional that you can include are:
1. Responsibility
2. Summary of Procedure
3. Not operational conditions
4. Accuracy and /or Components of Measurement Uncertainty
5. Calibration Status
6. Calibration Certificate Content
7. Correction or Adjustment procedure
8. General Notes
ISO 22000 Calibration Requirements
Calibration is very important not just in the manufacturing sector but also in the Food
Industry. It is one of the main requirements in order to properly manage Food Safety.
Calibration is needed for reliable and accurate monitoring and measuring instruments. With
the importance of calibration in the food industry specifically in maintaining food safety, the
following are the requirements of ISO 22000:2018 to control monitoring and measuring
instruments:
1.calibrated or verified at specified intervals prior to use;
2.when necessary, an adjustment should be performed;
3.calibration status should be identified;
4.safeguarded from adjustments that would invalidate the measurement or calibration
results;
5. properly handled to protect from damage and deterioration;
6. calibration and verification results are documented and retained;
7. calibration performed is traceable to international standards;
8. measurement results are reviewed and verified to conform with the requirements
and specifications, any non-conformances are dealt with appropriate actions.
I know that this article is focused on ISO 9001 calibration requirements, but upon checking it
with ISO 22000, Food Safety Management System, there are almost no differences
between ISO 9001 and ISO 22000 in terms of calibration requirements.Therefore, you can
apply everything that I have discussed above.
Conclusion
ISO 9001 Standards is a Quality Management System that is well known and applicable for
almost all industries. One of the major requirements under this standard is the
implementation of calibration.
Calibration provides quality, reliability, and safety of manufactured products, therefore, it
has a dedicated clause focused mainly on implementing the calibration process.
In this post, I have shared the following:
1. The related clause of ISO 9001 are focused mainly on calibration requirements.
These are:
•
o Clause 7.1.2 People.
o Clause 7.1.4 Environment for the operation of processes.
o Clause 7.1.5.1 General monitoring and measuring requirements
o Clause 7.1.5.2 Measurement traceability
o Clause 7.2 Competence
o Clause 9.1.1 General requirements for monitoring, measurement, analysis,
and evaluation.
2. ISO 9001 Calibration procedure – The content of a calibration procedure
If you want an in-depth understanding of calibration management and calibration processes,
you can use ISO 17025:2017 as the Quality Management System. This Standard is
dedicated to testing and calibration laboratories.
