ISO 9001 clause 7.1.5 internal audit checklist
26 audit questions across the six requirements of clause 7.1.5, each with the objective evidence that answers it. Work through it, record your findings, and download the completed audit as a CSV. Nothing is sent anywhere and there is no signup. AS9100D builds on this same clause. It adds a register of monitoring and measuring equipment and a recall process for anything due, so aerospace suppliers can start here and layer those on top.
This is our own audit wording organized by the structure of the clause. It does not reproduce the text of ISO 9001, which is a copyrighted standard.
Audit details
1. Suitable resources are provided
The first requirement is that the equipment exists and is right for the job. Most nonconformities here are scope problems rather than calibration problems.
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1.1 Is there a single register of every monitoring and measuring resource used to judge product or process conformity?
Look for: One list, not several. Ask for it by name and see how long it takes to produce.
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1.2 For each resource, is its accuracy or measurement uncertainty adequate for the tolerance it is used to judge?
Look for: A stated tolerance and a stated instrument uncertainty for at least the critical characteristics. A test uncertainty ratio is the usual way this is shown.
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1.3 Where software performs or interprets a measurement, has its fitness for that use been confirmed before use?
Look for: Evidence of a verification against a known input, not a supplier claim.
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1.4 Are personal or uncontrolled instruments prevented from being used for conformity decisions?
Look for: Walk the floor. Uncontrolled calipers in a toolbox are the most common finding in this clause.
2. Fitness is maintained and evidenced
The requirement is not only that equipment is fit, but that you retain documented information showing it.
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2.1 For any instrument named at random, can the evidence of its fitness be retrieved during the audit?
Look for: Pick the instrument yourself rather than accepting one offered. Time the retrieval.
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2.2 Does that evidence show who performed the work and on what date?
Look for: An attributable record. A certificate with no technician and no date is weak evidence.
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2.3 Are maintenance, repair and damage events recorded against the instrument record?
Look for: A history on the asset, not a separate maintenance file nobody links to it.
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2.4 Is the retention period for these records defined, and is it being met?
Look for: A stated period, and records that actually reach back that far.
3. Calibration against traceable standards
This applies where measurement traceability is a requirement, or where the organization considers it essential for confidence in the result.
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3.1 Is each in-scope instrument calibrated or verified at defined intervals, or before use?
Look for: A due date per instrument and evidence the date is being met, not just planned.
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3.2 Is calibration performed against standards traceable to international or national measurement standards?
Look for: The certificate names the reference standards used and their own traceability. A supplier logo is not traceability.
Metrological traceability explained
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3.3 Where no such standard exists, is the basis used for calibration or verification retained as documented information?
Look for: A written basis. This is the sub-requirement most programs miss entirely, because it only bites on unusual measurements.
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3.4 Is there a documented basis for each calibration interval, rather than a default inherited from a supplier?
Look for: Any defensible basis: manufacturer guidance, risk, usage, or reliability from your own as-found history.
Calibration interval calculator
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3.5 For external calibration, is the supplier’s scope of accreditation checked against the measurement actually purchased?
Look for: The scope document, not the certificate. Accreditation covers named measurements and ranges, not the whole price list.
Approving a calibration supplier
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3.6 Do incoming certificates state measurement uncertainty, and is a decision rule applied when a reading sits near a limit?
Look for: A stated uncertainty and a stated rule. Silence about the rule is itself a finding.
Guard banding and decision rules
4. Calibration status is identifiable
The test is whether the person about to use an instrument can tell whether it may be used. Not whether a manager can find out later.
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4.1 Can the calibration status of any instrument be determined by the person about to use it?
Look for: Ask an operator, not the quality manager. This is the question that separates a real system from a register.
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4.2 Is status visible at the point of use, not only in a central system?
Look for: A label, a tag, a scannable code, or a screen at the bench.
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4.3 Is status unambiguous for instruments that are due, overdue, withdrawn, or awaiting a decision?
Look for: More than one state. A pass or fail label cannot express quarantine.
5. Equipment is safeguarded
Protection from adjustment, damage and deterioration that would invalidate the calibration status.
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5.1 Are instruments protected from adjustments that would invalidate their calibration status?
Look for: Seals, locked settings, restricted access, or a documented control. Consider who can zero or span the device.
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5.2 Where adjustment is a normal part of use, is permitted adjustment distinguished from adjustment that voids calibration?
Look for: A written distinction the user can act on. This is where an honest program differs from a sealed-and-forgotten one.
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5.3 Are instruments protected from damage and deterioration in handling, storage and transport?
Look for: Storage conditions and cases. Check the environment against anything the manufacturer specifies.
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5.4 Is there a route for a user to report a suspect instrument and take it out of service immediately?
Look for: A named route and evidence it has been used. A route nobody has ever used is a route nobody knows about.
6. Action when equipment is found unfit
This is the sub-requirement that carries the most risk and the least attention. When an instrument turns out to have been wrong, the standard asks what that did to everything it measured.
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6.1 Is the as-found condition recorded before any adjustment is made?
Look for: As-found readings on the certificate. Without them the next three questions cannot be answered at all, which is why this one comes first.
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6.2 When an instrument is found out of tolerance, is a determination made about the validity of previous measurement results?
Look for: A written determination, not a verbal one. It should exist even when the conclusion is that nothing was affected.
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6.3 Is the affected population identified back to the last calibration known to be good?
Look for: A defined range of product, batches or dates. "We think it was fine" is a nonconformity.
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6.4 Is appropriate action taken on the affected product or process, and recorded?
Look for: The action and its outcome, linked to the determination above.
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6.5 Is the calibration interval reviewed after an out-of-tolerance result?
Look for: Evidence the interval was reconsidered. An unchanged interval is fine if the reasoning is recorded.
Findings
| Result | Count |
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The CSV opens in Excel, Google Sheets and LibreOffice. Everything runs in your browser and nothing you type leaves your machine.
What this is and is not
This is a working aid for an internal audit of clause 7.1.5, and for preparing for an external one. It does not certify or guarantee conformance and neither does any software. Your procedures, your evidence, and your auditor or registrar decide that.
It also does not reproduce ISO 9001. The clause numbers are citations and the questions are ours. If you need the normative text, buy the standard from ISO or your national standards body. A checklist written by anyone, including us, is not a substitute for reading it.
Common questions
- What does ISO 9001 clause 7.1.5 cover?
- Monitoring and measuring resources. It has two parts. The general part asks you to provide resources that are suitable for the monitoring and measurement being done, to keep them fit for that purpose, and to retain documented information showing they are fit. The traceability part applies where measurement traceability is a requirement or where you consider it essential, and it adds calibration or verification at defined intervals against traceable standards, identification of status, safeguarding, and a determination about previous results when equipment is found unfit.
- Is this checklist the text of ISO 9001?
- No, and deliberately not. ISO 9001 is a copyrighted standard and its clause text is not reproduced here in whole or in part. Every question on this page is our own wording about what an auditor looks for, organized by the structure of the clause. Clause numbers are citations. If you need the normative text, buy the standard from ISO or your national standards body. A checklist is not a substitute for it.
- Why is there no score out of 100?
- Because an internal audit does not produce a score, and presenting one would misrepresent what a finding is. Three nonconformities against a well-run program can be less serious than one against a weak one, and averaging them hides that. The panel tallies findings by type, which is what an audit report actually carries. If you want a scored view of your overall program, the audit readiness self-assessment is the tool for that.
- Which question in clause 7.1.5 causes the most findings?
- In our experience it is the last group, action when equipment is found unfit. Programs record the out-of-tolerance result, then stop. The clause also asks what that instrument did to everything it measured since the last good calibration, which means identifying the affected product and taking action on it. That determination is only possible if as-found condition was recorded before adjustment, which is why the as-found question sits first in that section.
- Does using this checklist make us compliant?
- No. Nothing on this page certifies or guarantees conformance and no software does either. Your procedures, your evidence, and your auditor or registrar decide that. This is a working aid for an internal audit and for preparing for an external one.
- Do I have to sign up to use it or download the results?
- No. There is no account, no email gate and no trial. Everything runs in your browser, nothing you type is sent anywhere, and the CSV is generated on your machine.
Related
Most of this checklist is a records problem
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