Calibration is a critical requirement in ISO 9001 and IATF 16949 to ensure measurement accuracy and product quality. Any error in measuring instruments can lead to rejection, customer complaints, and audit non-conformities. In this guide, you will learn the complete calibration procedure with practical industry examples, formats, and audit requirements.
What is Calibration?
Calibration is the process of comparing a measuring instrument with a standard (master instrument) to verify its accuracy and make necessary adjustments.
Calibration requirement in IATF 16949
As per Clause 7.1.5.2.1 (Calibration/Verification):
- Instruments must be calibrated at defined intervals
- Calibration must be traceable to national/international standards
- Calibration status must be identified
- Records must be maintained
- Reaction plan must be defined for out-of-calibration instruments
Calibration is closely related to measurement accuracy, which you can further understand in this Measurement System Analysis (MSA) guide
Objectives of Calibration
- Ensure measurement accuracy
- Maintain product quality
- Reduce rejection and rework
- Meet customer and audit requirements
Scope
This procedure applies to all measuring instruments used in production, inspection, and testing.
Responsibility
- QA Department: Calibration planning and records
- Production: Ensure use of calibrated instruments & safe handling of instruments
Calibration Procedure (Step-by-Step)
Step 1: Prepare Master List
Maintain a list of all measuring instruments including:
- Instrument name
- Unique ID
- Location
- Calibration frequency
Step 2: Define Calibration Frequency
Set frequency based on:
- Usage
- Criticality
- Manufacturer recommendation
Step 3: Identification of Instruments
Each instrument should have:
- Calibration sticker
- Due date
- Status (OK/NOT OK)
Step 4: Perform Calibration
Calibration can be:
- Internal (using master instrument)
- External (NABL approved lab)
Step 5: Record Results
Record:
- Standard value
- Observed value
- Deviation
- Acceptance status
Step 6: Handling Out-of-Calibration
If instrument is out of calibration:
- Stop using instrument
- Identify affected products
- Re-inspect products
- Inform customer if required
- Take corrective action
Practical Examples
Example 1: Vernier Caliper Calibration
- Use slip gauge (10 mm, 20 mm)
- Compare readings
- Accept if within ±0.02 mm
Example 2: Pressure Gauge Calibration
- Compare with master gauge
- Check at 25%, 50%, 75%, 100%
Calibration Process Table
| Step | Activity | Responsibility |
|---|---|---|
| 1 | Prepare master list | QA |
| 2 | Define frequency | QA |
| 3 | Perform calibration | QA/External |
| 4 | Record results | QA |
| 5 | Action for rejection | QA + Production |
Types of Calibration
- Internal Calibration
- External Calibration
Important Audit Points
- Calibration status clearly visible
- No expired instruments in use
- Records available and updated
- Traceability maintained
Common mistakes
- Using expired instruments
- Missing calibration records
- No reaction plan
- Improper identification
Procedure in details :
Master list of Instruments :
Identify all the Instruments and gauges for measurement as required for all the stages of production. Prepare a list covering all the instruments & gauges available in the organization and maintain a Master list of instruments & gauges. Provide unique identification numbers to all monitoring and measuring equipment and gauges.
Calibration Plan :
A “Calibration Plan” is prepared for the instruments and gauges as per the appropriate frequency. The Calibration frequency is based on uses, make & recommendations of manufacturers etc. Calibration plan containing the date of calibration, Due date and method of calibration. Calibration is performed by either Internal or by External agencies.
Internal Calibration :
For performing Internal calibration, a proper lab is required and a qualified & experienced person is required for doing the calibration. Also calibrate the master instrument from the NABL-approved lab and maintain the record.
External Calibration :
For performing External calibration, the External Agencies used for calibration shall be accredited/approved by a National Laboratory (NABL) or ISO / IEC 17025 certified. Where a qualified laboratory does not exist for a particular piece of equipment, calibration services may be performed by the original equipment manufacturer (OEM) and their names shall be included in the approved Supplier list.
The scope of the external agency also checks before doing calibration from any agency to check whether the calibration of that equipment is within the scope of that agency or not.
The calibration activities are carried out as per the plan and the calibration certificate is verified for the acceptance of the instrument with the defined standard for acceptance criteria. Receipt of Calibration Certificate from external sources and examine the same for adequacy or result under the acceptance criteria.
In case the equipment shows NG values or results found out of acceptance criteria, send back it for repair, if possible. Otherwise, put a reject sticker or red paint mark over it and update the relevant records accordingly.
New Instrument :
In case of a new / repaired instrument ensure that it is calibrated before bringing it into use. Also update the Master List, Calibration plan and individual instrument calibration record (Instrument History card)
Master Instruments :
Keep the Master Instrument in safe and secure condition and ensure that the Master Instrument is not used for regular purposes. Cleaning of Master Instrument is ensured and application of preservatives as applicable while storing for a longer period.
Instruments handling :
Handle and store the calibrated instrument in such a way that their accuracy and fitness for use are maintained. In case the instrument falls down during use or gets damaged, send the same to the Standard Room for checking/repairing or re-calibration, if required.
You may like to know about How to maintain measuring instruments
Out of Calibration :
In case the date of calibration is over the grace period of the same will be given of 15 days. Also the material inspected with that gauge shall be identified separately. If possible the calibration of instruments should not be later than the due date.
During Calibration following calibration records are to be checked:
- Follow the engineering changes that impact the measurement system.
- Check that any specifications readings are received from the agency.
- Check the risk of that out-of-specification reading on the product.
- During Calibration, if any instrument is found to be out of calibration (the error exceeding the acceptance criteria), an out-of-calibration report is to be raised. One of the following actions will be taken on the equipment: a) Recondition and re-calibrate b) Replace the equipment and document the validity of the previous inspection and the test results.
- Wherever evidence is available for shipment of the suspect product, the customer is to be notified.
- Check & verify the specification after re-calibration.
- Verify the latest software which are used for product and process and maintained record.
- Maintain the calibration record of all instrument
FAQ :
What is calibration procedure for measuring instruments
Calibration procedure is a step-by-step method of checking and adjusting measuring instruments by comparing them with a standard to ensure accuracy and compliance with quality standards like IATF 16949
What is calibration of measuring instruments
Calibration of measuring instruments is the process of verifying the accuracy of an instrument by comparing its readings with a known standard and correcting any deviation if required
What are the steps in calibration process
The calibration process includes preparing a master list, defining calibration frequency, identifying instruments, performing calibration, recording results, and taking action for out-of-calibration instruments
What is calibration method in quality control
Calibration method in quality control refers to the technique used to compare an instrument with a reference standard either internally using master instruments or externally through NABL approved laboratories
What is the difference between calibration and verification
Calibration is the process of adjusting an instrument to match a standard, while verification is only checking whether the instrument meets specified requirements without making any adjustments
Conclusion
A proper calibration system ensures product quality, reduces rejection, and helps in successful IATF audits. Organizations must maintain calibration records, follow defined frequency, and take immediate action for out-of-calibration instruments.

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