Compliance and audits
Calibration labels and stickers: what goes on them and what the standards require
ISO 9001 clause 7.1.5.2 and ISO/IEC 17025:2017 clause 6.4.8 ask for equipment to be identified so that its calibration status can be determined, but neither lists fields for a sticker, and ISO/IEC 17025 allows a label, a code or another means of identification. What goes on a calibration label is largely your decision, within a few limits such as clause 7.8.4.3 on printing an interval and the rules on accreditation symbols.
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What do the standards actually require?
The requirement is about status, not stickers. ISO 9001 clause 7.1.5.2 asks for measuring equipment to be identified so that its status can be determined. ISO/IEC 17025:2017 clause 6.4.8 goes further for a laboratory: a user of the equipment has to be able to tell easily whether it is in calibration or within its validity period, and a label, a code or another means will do. Neither clause says what a label has to contain.
This is narrower than it used to be. Clause 5.5.8 of the 2005 edition of ISO/IEC 17025 asked, whenever practicable, for the label to include the date last calibrated and the date or criteria for recalibration. The 2017 edition dropped that wording and keeps the calibration dates and the due date or interval in the equipment records, under clause 6.4.13 e).
| Source | What it asks | Fields it names |
|---|---|---|
| ISO 9001 clause 7.1.5.2 | Identify equipment so that its status can be determined | None |
| ISO/IEC 17025:2017 clause 6.4.8 | Make it easy for whoever picks up the item to see whether its calibration or validity is current. A sticker works, and so does a code or other marking | None |
| ISO/IEC 17025:2017 clause 6.4.9 | Stop using a faulty or failed item. Set it aside or mark it out of service, and bring it back only after a check shows that it works | An out-of-service mark |
| ISO/IEC 17025:2017 clause 7.8.4.3 | A lab keeps any suggested recalibration interval off its certificates and stickers unless the customer has agreed to it | Rules out one item |
| ILAC-P8:11/2023 clause 8.1 | For a calibration label carrying an accreditation symbol: usually the lab's name and accreditation number, equipment identification, date of current calibration and a reference to the certificate | Four usual items, for labels with the symbol only |
What should a calibration label show?
Because the standards leave the layout to you, build the label around the decision the user has to make at the point of use. These are the usual fields and the reason for each.
| Field | Why it is there | Where it comes from |
|---|---|---|
| Instrument ID | Ties the label to one item and its record | Usual with an accreditation symbol (ILAC-P8 clause 8.1) |
| Status | Tells the user whether the item can be used | ISO/IEC 17025:2017 clause 6.4.8 |
| Calibration date | Shows how old the calibration is | Usual with an accreditation symbol |
| Next due date | Shows the period of validity | Your choice, or your customer's |
| Calibrated by | Points to the lab or the person responsible | Lab name usual with an accreditation symbol |
| Certificate number | Links the label to the document with the results | Usual with an accreditation symbol |
| Limitation | States what the item may not be used for | Needed on a limited calibration label |
Should the label show a due date?
It depends on who sets the interval. If you own the instrument and set its interval, the due date is yours to print, and it is the plainest way to show the period of validity.
A laboratory calibrating for a customer is in a different position. Under ISO/IEC 17025:2017 clause 7.8.4.3 the lab does not suggest how often to recalibrate, on its certificate or on its sticker, unless you and the lab have agreed on that. So tell the lab which date to print, or tell it to print none, and keep the interval decision in your own records.
What about limited use, do-not-use and out-of-service labels?
When a gage has been dropped or overloaded, or it fails calibration or starts giving doubtful readings, a lab working to ISO/IEC 17025:2017 clause 6.4.9 stops using it. The lab then sets the gage aside where it cannot be used, or marks it so that nobody picks it up by mistake, and it stays that way until a check shows that it works again. A do-not-use label is the visible part of that decision. The lab also has to work out what the problem did to earlier results.
A limited calibration label says an item may be used only within stated limits. MIL-STD-45662A section 5.10 asked for items not calibrated to full capability, or with other limits of use, to be labeled or otherwise identified with those limits. NASA's directive asks for the limits to be stated on the label wherever possible, and for such an item to be used only when its limits are known to the user.
| Label | When it applies | What the user does |
|---|---|---|
| Calibrated | In date and calibrated to its full specification | Uses it normally |
| Limited calibration | Calibrated only for part of its range, accuracy or function | Uses it only within the stated limits |
| Do not use or Out of service | Defective, overloaded, questionable or found out of tolerance | Keeps it out of use until it has been shown to work correctly |
| Not calibrated | Normally kept in calibration but past due and not in use | Does not use it until it has been calibrated |
| Calibration not required | A general indication is all that is needed | Does not use it for quality, safety or calibration work |
| Calibrate before use | Needs calibrating right before each use | Calibrates it first and records the result |
| Calibration void if seal broken | Sealed over an internal adjustment | Reports the seal if it is broken |
Do you need tamper seals?
ISO 9001 clause 7.1.5.2 expects you to protect a gage so that nothing undoes its calibration, whether tampering or rough treatment. ISO/IEC 17025:2017 clause 6.4.12 wants a lab to guard against settings being changed by accident. Neither names a seal, but a seal is a simple way to show that nobody has touched an adjustment.
MIL-STD-45662A section 5.10 required tamper-resistant seals on accessible controls or adjustments that would affect the calibration, with instructions for what to do with items whose seals were broken. NASA's directive asks for a tamper-resistant label, where practical, on equipment that can be disassembled for adjustment. It does not cover adjustments needed for normal setup, and it handles a broken seal like an expired calibration.
Decide in advance what a broken seal means in your system, who investigates it and what happens to the results since the last good calibration.
Can a code or QR label replace a sticker?
Yes, if the person using the equipment can readily tell its status. ISO/IEC 17025:2017 clause 6.4.8 allows a code or another means, so a number that points to a register can work as long as the user can reach that register at the point of use. A code that only the calibration office can decode does not meet that test.
Some items are too small or awkward for a label. MIL-STD-45662A allowed the label to go on the container of an item such as a gage block. NASA's directive lists a hanging tag, the packaging or a front panel on the rack. Keep the tag with the item.
A QR code has one advantage over a printed date. It can open the live record, so the status it shows is today's. Its weakness is that it needs a phone in the user's hand. You can combine the two, with a plain status word and date on the label and a code beside them.
Common calibration label mistakes
- A Calibrated sticker left on an instrument that has since been put out of service. The label has to change when the status changes.
- A date on the label that does not match the record. NASA's directive asks for labels to be kept current.
- More than one status label on the item. NASA's directive allows only one, and a new label may go over the old one.
- An unlabeled instrument on the bench. NASA's directive treats equipment without a valid label as not calibrated for quality and safety measurements.
- An accreditation claim on a label that cannot support it. A label with an accreditation symbol is limited to work in the lab's scope (ILAC-P8 clause 8.1).
- A Pass or In tolerance on the sticker. A statement of conformity needs the specification and the decision rule, which ISO/IEC 17025:2017 clause 7.8.6 asks the report to identify. Point to the certificate instead.
- Label stock that fades or peels before the calibration expires. Match the stock and the print method to the environment.
How to set up calibration labels, step by step
- Write down who reads the label and what decision it supports.
- Check the requirements that apply to you: ISO 9001, ISO/IEC 17025, your customers' contracts and any legal rules.
- Choose your status words and define each one in your procedure.
- Decide the fields. Start with a unique ID and a status, then add what your requirements call for.
- Choose label stock and a print method that survive your environment, including heat, solvents and handling.
- Decide where the label goes on each kind of instrument, and what to do for items too small to label.
- Say who applies labels and who removes them, and what happens to the old label when the status changes.
- Set the rule for tamper seals and for broken seals.
- Sample instruments on a schedule and check that the label and the record agree.
How Axiospec helps with calibration labels
Axiospec is calibration management software, and it prints calibration labels from the instrument record. Pick instruments on the Labels page, choose what the label says and print a PDF on Avery 5160 sheets or on a custom size. The label types are Calibrated, Limited calibration, Out for calibration, Do not use, ID tag only and Reference only.
A Calibrated label prints the next due date and the last calibration date from the record. An instrument with no calibration on record is reported and skipped, so no sticker goes out with a blank date. A Limited calibration label prints the stated restriction, and a Do not use label prints the ID and a QR code with no dates. Axiospec does not print a recorded Pass or Fail, and it refuses a typed restriction that makes an accreditation or conformity claim such as NIST traceable or In tolerance.
A QR code on the label, where the stock is large enough to hold one, opens the instrument's record for anyone signed in to your workspace, so their scan shows the live status. Someone without a login cannot read it, so keep a plain status word and date on the label for them. Axiospec does not decide what your labels have to say, and it cannot check that a sticker is on the instrument.
Labels work on every plan. It is free for up to 50 active instruments. A new workspace starts with a 45-day trial of Professional, with room for 1,500 active instruments. We load your existing records for you at no charge on every plan.
Common questions
- Does ISO 9001 require a calibration sticker?
- No. ISO 9001 clause 7.1.5.2 asks for equipment to be identified so that its status can be determined, and a sticker is only one way to do that. The clause does not name fields for a sticker.
- What must be on a calibration label?
- ISO/IEC 17025:2017 clause 6.4.8 names no fields, so the label has to make the calibration status or period of validity clear to the user. A label carrying an accreditation symbol usually shows the lab's name and accreditation number, the equipment identification, the date of current calibration and a certificate reference, as ILAC-P8:11/2023 clause 8.1 lists.
- Can a calibration lab print a due date on the sticker?
- Only if the customer agreed to it. Under ISO/IEC 17025:2017 clause 7.8.4.3 a lab does not suggest a recalibration interval on its certificate or sticker without that agreement. An owner setting its own interval can print its own due date.
- Can a QR code replace a calibration sticker?
- Yes, where the user can readily tell the status from it. ISO/IEC 17025:2017 clause 6.4.8 allows a code or another means of identification in place of a label, but a code only the calibration office can read does not meet that test.
- What is a limited calibration label?
- It marks an instrument calibrated only for part of its range, accuracy or function, and it should state those limits. The user can rely on the instrument only within them.
- What should you do when a calibration seal is broken?
- Treat the instrument as not calibrated until someone has investigated. NASA Glenn's directive GLPR 8730.6F handles a broken tamper-resistant label in the same way as an expired calibration.
Put it into practice
Got a gage list? Send it over and we load it for you, usually in a couple of business days. Free on every plan. Then log every calibration to a tamper-evident audit trail and produce records on demand.
Axiospec is a documentation and workflow tool. It helps you keep clean, traceable, audit-ready records. Certification depends on your own processes, scope and assessor.
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