Monitoring and measuring resources

In plain words

If you measure in order to prove conformity — the caliper that decides whether the part is within tolerance — then this clause demands: make sure your measuring equipment measures correctly. Fit for the task, monitored, and where needed calibrated — against a standard that is traceable to a national or international reference standard (7.1.5.2). The state of the equipment must be evidenced, and an instrument found faulty forces the question: were the parts released with it still good?

The condition in the first sentence matters: only if you measure to prove conformity. A company that makes no critical measurements — pure trading, consulting, many services — can declare this requirement not applicable, with a reason. For a precision manufacturer, by contrast, it is the heart of quality assurance.

And the distinction that saves money: calibrating means determining how far an instrument deviates from the truth; adjusting means correcting it. The standard demands knowing whether the instrument is right — not having every instrument expensively readjusted.

Why this requirement exists

A mismeasuring instrument is more dangerous than none: it delivers confidence without cover. If the caliper reads 0.02 mm low, parts leave the house as “good” for weeks when they are not — and the error surfaces at the customer, accumulated and expensive. The clause exists so this silent drifting is noticed before it becomes a complaint wave.

Traceability (7.1.5.2) is the chain of trust: your caliper is checked against a standard, the standard against a better one, and so on up to the national metrology institute. Without this chain, “calibrated” is just a sticker. With it, a customer — or a court in a liability case (product liability) — can believe your measurement.

What good looks like

In a company of 12 people: a list of the inspection-relevant measuring equipment — which instrument, where, calibration interval, last and next calibration, status. Critical instruments go to an accredited calibration laboratory (with a traceable certificate); non-critical ones are checked in-house against a calibrated standard. Every instrument carries a visible identification (number, calibration date), so in doubt it is clear whether it is valid.

You recognise a good solution by two things. First, the intervals fit the usage — the daily-used caliper more often than the once-a-year gauge; not every instrument on the same rigid clock. Second, there is a rule for the failure case: if a calibration reveals a deviation, an assessment follows of which parts released since the last valid check are affected — the part most people forget and auditors check most precisely.

What changes as you grow: From around 50 people, simple gauge-management software with automatic due-date warnings pays off; from 100–250 people, measurement-uncertainty considerations and capability studies for inspection processes (MSA/Gage R&R) join where customers or the industry demand them. The core remains: whoever measures to release must be able to trust the instrument — demonstrably.

The minimum to pass

• An overview of the inspection-relevant measuring equipment with calibration status and interval.
• Critical instruments are calibrated traceably — with certificate; non-critical ones demonstrably monitored.
• The instruments are identified, so validity is recognisable.
• There is a rule for the deviation case — what happens with already-released parts when an instrument turns out faulty.
• Or, if not applicable: a justification that no measurements prove conformity.

What an auditor asks for

• The equipment list — and the spot check: pick up an instrument, read its identification, want to see the calibration certificate behind it.
• A traceable certificate from an accredited laboratory for a critical instrument.
• The due-date control: is an instrument overdue — and was it then locked or still used?
• The deviation case in concrete terms: “What do you do when a caliper fails calibration?” — the answer separates lived calibration from sticker calibration.
• Where “not applicable”: the justification — and the cross-check on the tour that no conformity-relevant measuring actually happens.

Common traps

• The calibration sticker without the chain. “Calibrated” without a traceable certificate is worthless — the most common finding. Traceability is half the requirement.
• Calibrating everything, including the non-critical. The folding rule used to measure the pallet space needs no calibration. Whoever calibrates everything wastes money and dilutes the attention for the critical instruments.
• The forgotten deviation case. An instrument fails, is replaced — and nobody asks about the parts it last released. Exactly this backward question is the core of 7.1.5.
• Rigid intervals. Every instrument “once a year”, regardless of use. Usage-based intervals are cheaper and safer.
• Confusing calibrating with adjusting. The standard wants to know whether the instrument is right. A slightly deviating but known-deviating instrument can remain usable — expensive readjustment is not always necessary.
• Declaring not-applicable too broadly. Whoever has a single critical measuring step cannot exclude 7.1.5 entirely. The exclusion holds only if truly nothing is measured to prove conformity.

Worked example

For Berger Präzisionsteile GmbH this clause is core craft. Their equipment list has 14 positions: micrometers, calipers, gauge blocks, a dial indicator, two gauges, a height gauge. The critical instruments go yearly (the daily-used ones half-yearly) to an accredited laboratory; the gauge blocks serve in-house as the standard for quick interim checks. Every instrument carries a number and the calibration sticker; Lea checks the due dates quarterly.

The teaching case came in spring: a micrometer failed calibration at +0.015 mm. Instead of merely replacing it, Lea walked the 7.1.5 question — which parts were measured and released with it since the last valid calibration? Affected: one batch of medical parts with tight tolerance. Re-measuring with a valid instrument showed: all in the field, the deviation lay within the margin. The result was documented, the customer not troubled — but the evidence existed. In the certification audit, exactly this clean backward assessment was the moment the auditor noted the measuring-equipment control as exemplary (the same praise that fell in the internal audit, 9.2).

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