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Audit template in the LeanSuite app

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ISO 9001 internal audit checklist

Internal audit questions organised by ISO 9001 clause. Use it for your internal audit programme.

Use this template in LeanSuitePrintable version (PDF)

The full question list

The 46 questions in the audit

Every question is answered Yes, No or N/A. Each No is flagged and asks for a photo and a comment, so the finding arrives with its evidence.

Receiving and incoming inspection: Sample: 5 receipts from the last 3 months from at least 3 suppliers, plus one rejected or held lot if there is one.

  1. 1Pick a receipt from today and follow it: was it checked the way the inspection plan sets for that part and supplier before it went to stock? Look for: the inspection plan, the inspection record, the stock location and its status. (8.4.2 Type and extent of control)
  2. 2How was the amount of incoming checking set for each supplier, and when was it last changed after a supplier problem? Look for: supplier ratings or a skip-lot rule, one recent change and its reason. (8.4.2 Type and extent of control)
  3. 3Do the certificates or test reports the purchase order asks for arrive with the material, and does someone compare them with the specification? Look for: the requirement on the purchase order, the certificate, the recorded check. (8.4.2 Type and extent of control)
  4. 4Are material waiting for inspection, accepted material and rejected material kept apart and marked, so nobody can use the wrong one? Look for: a marked hold area, tags or labels, the system status matching the tag. (8.5.2 Identification and traceability)
  5. 5When a lot failed incoming inspection, was it recorded and held, and was the supplier asked for a response? Look for: the nonconformance report, the hold tag, the supplier corrective action request and its status. (8.7 Control of nonconforming outputs)

Production planning and control: Sample: 3 jobs running now and 2 closed in the last month, from different lines or shifts.

  1. 6Does each running job have a released work order with the current drawing or specification revision, the quantity and the route? Look for: the work order at the machine, its revision against the controlled master. (8.1 Operational planning and control)
  2. 7Were material, tooling, programs and people confirmed before the job started, and what happens when one is missing? Look for: a kitting or pre-start check, the shortage list, one late start and its reason. (8.1 Operational planning and control)
  3. 8Are the machines in the sample maintained to their plan, and are overdue preventive maintenance tasks visible to the area? Look for: the PM schedule and completion records, open breakdown work orders. (7.1.3 Infrastructure)
  4. 9Does the area track its process measures (scrap, first pass yield, on-time output), are they current, and what was done the last time one missed? Look for: the board or report, the last miss and its action. (9.1 Monitoring, measurement, analysis and evaluation)
  5. 10Has someone looked at what can go wrong in this process (a risk list, a PFMEA or similar), and are the actions from it in place on the floor? Look for: the risk record for this process, one action traced to the station. (6.1 Actions to address risks and opportunities)

Work instructions and process control: Sample: 4 stations, including the newest operator in the area and a job started this shift.

  1. 11Is the instruction at the station the current revision, readable, and the same as the controlled copy? Look for: the revision at the station against the document system, uncontrolled copies, handwritten changes. (7.5.3 Control of documented information)
  2. 12Ask the operator to talk you through the job: does the work match the instruction, step by step? Look for: the steps you watch against the sheet, any step done differently and why. (8.5.1 Control of production and service provision)
  3. 13Are machine settings (temperature, pressure, speed, torque) inside the limits the instruction or control plan sets, and checked as often as it says? Look for: the settings on the machine, this shift's check sheet. (8.5.1 Control of production and service provision)
  4. 14Where a result cannot be fully checked afterwards (welding, heat treating, sealing, bonding), is the process validated and run as validated, by qualified people? Look for: the validation record, the settings in use, the operator's qualification. (8.5.1 Control of production and service provision)
  5. 15Is the first piece approved and recorded before the run, and are in-process checks done at the set frequency? Look for: the first-piece record with time and signature, the in-process check sheet for this run. (8.6 Release of products and services)
  6. 16Are the conditions the process needs in place (lighting, cleanliness, temperature or humidity where the product needs it)? Look for: the conditions the instruction asks for, a reading or log where one is required. (7.1.4 Environment for the operation of processes)

Calibration and measuring equipment: Sample: 6 gauges in use today, picked at the stations rather than from the calibration list, including one used to release product.

  1. 17Does every gauge in use carry an ID and a calibration status, and is it in date? Look for: the ID and label on the gauge, the due date in the calibration register. (7.1.5.2 Measurement traceability)
  2. 18Can the calibration record show what the gauge was checked against, and that the reference traces to national or international standards? Look for: the certificate, the reference standard, the lab's accreditation for outside calibration. (7.1.5.2 Measurement traceability)
  3. 19When a gauge was found out of tolerance at calibration, was the product measured with it since its last good calibration reviewed? Look for: the out-of-tolerance record, the lots reviewed, the decision and who made it. (7.1.5.2 Measurement traceability)
  4. 20Is each gauge fit for the measurement it is used for: resolution against the tolerance, and a gauge study where the control plan asks for one? Look for: the drawing tolerance, the gauge resolution, the gauge R&R result. (7.1.5 Monitoring and measuring resources)
  5. 21Are gauges protected from damage and from adjustments that would make readings wrong? Look for: storage at the station, seals on adjustable settings, damaged gauges still in use. (7.1.5.2 Measurement traceability)

Nonconforming product: Sample: the hold area today and 3 nonconformance reports from the last 3 months, one involving the customer if there is one.

  1. 22Is every suspect or rejected part in the area tagged, kept apart and recorded? Look for: the hold area, tags against the nonconformance log, parts on benches or under machines with no tag. (8.7 Control of nonconforming outputs)
  2. 23For each report in the sample, is the decision recorded (rework, scrap, use as is, return) with who authorized it? Look for: the disposition, the name, the date. (8.7 Control of nonconforming outputs)
  3. 24Where parts were used as is or repaired, was customer agreement obtained when the contract needs it, and were reworked parts checked again? Look for: the concession or deviation, the re-inspection record. (8.7 Control of nonconforming outputs)
  4. 25When a problem was found after shipping, was the suspect stock traced and contained and the customer told? Look for: the containment record, the lots traced, the message to the customer. (8.7 Control of nonconforming outputs)

Corrective action: Sample: 3 corrective actions closed in the last 6 months (one from a complaint, one from an audit) and the open list.

  1. 26Was containment done first, and was the cause proven rather than assumed? Look for: the containment record, a 5 whys, fishbone or trial that confirms the cause. (10.2 Nonconformity and corrective action)
  2. 27Does the action remove the cause, and is it in place on the floor today, not only in the report? Look for: the changed instruction, fixture, setting or training, seen at the station. (10.2 Nonconformity and corrective action)
  3. 28Was effectiveness checked with data after the action, and was the action closed only after that check? Look for: the effectiveness check, the period of data, who closed it and when. (10.2 Nonconformity and corrective action)
  4. 29Are actions closed by their due dates, and are late ones escalated? Look for: the open list, the oldest open action, due dates against today. (10.2 Nonconformity and corrective action)
  5. 30Were the findings from this area's last internal audit corrected and closed, and has any of them come back? Look for: the previous audit report, closure evidence, repeat findings. (10.2 Nonconformity and corrective action)

Identification, traceability and preservation: Sample: 3 lots, finished or in process: trace each one back to its material and forward to its shipment or location.

  1. 31Pick a finished part or container: can you trace it back to the material lot, machine, shift and inspection records, and forward to where it went? Look for: the label, the traveler or system record, the material certificate, the shipping record. (8.5.2 Identification and traceability)
  2. 32Is work in process identified at every stage (part number, revision, status), including parts left between shifts? Look for: labels on work in process, unlabeled containers, mixed parts. (8.5.2 Identification and traceability)
  3. 33Is product protected from damage, contamination and deterioration while it is handled, stored and moved, and is shelf-life material used in date? Look for: damaged or overstacked parts, open containers, expiry labels, first in first out lanes. (8.5.4 Preservation)

Competence and training: Sample: 5 people working in the area today, including a new starter and a temporary worker if there is one.

  1. 34Is each person in the sample qualified for the job they are doing today, by the training matrix or skills record? Look for: the person on the matrix at the level the job needs, and the date. (7.2 Competence)
  2. 35How was competence confirmed: by watching the person do the job to standard, not only a signed attendance sheet? Look for: a trainer's sign-off after observation, a test or a check. (7.2 Competence)
  3. 36Are trainees supervised, and are expiring qualifications (welding, inspection, forklift) caught before the person works alone? Look for: expiry dates, the refresher plan, who supervises each trainee. (7.2 Competence)
  4. 37Can operators say what makes a good part at their station and what to do with a bad one? Look for: their answers, compared with the instruction and the reaction plan. (7.3 Awareness)

Change control: Sample: the last 3 changes to the area (a process, a document, a machine or tool) from the change log or maintenance records.

  1. 38Was each change reviewed before it was made: who approved it, what it could affect, and what checks were planned? Look for: the change request, the approval, the risk review. (8.5.6 Control of changes)
  2. 39After the change, were the first parts checked, and were the instruction, control plan, training and gauges updated? Look for: first-off results after the change, the new revision, training records. (8.5.6 Control of changes)
  3. 40Were temporary changes (substitute material, another machine, a bypassed check) approved, limited in time or quantity, and ended on time? Look for: the deviation, its end date or quantity, the return to normal. (8.5.6 Control of changes)
  4. 41When a document changed, were old copies removed from the floor and the reason for the change recorded? Look for: superseded copies at stations, the revision history. (7.5.3 Control of documented information)

Customer property: Sample: every item of customer-owned material, tooling, gauges or packaging in the area; there are often fewer than 10.

  1. 42Is customer-owned property (material, molds, fixtures, gauges, returnable packaging) identified as the customer's, recorded, maintained and protected? Look for: tags or marks, the customer property register, maintenance records for customer tooling. (8.5.3 Property belonging to customers or external providers)
  2. 43When customer property was lost, damaged or found unsuitable, was the customer told and was it recorded? Look for: the record and the message to the customer. (8.5.3 Property belonging to customers or external providers)

Release and shipping: Sample: 3 shipments from the last week and one being prepared today.

  1. 44Was each lot released by an authorized person only after all the planned checks were done and passed? Look for: the final inspection record, who released it, the release date against the ship date. (8.6 Release of products and services)
  2. 45If product went out before all checks were complete, was that approved by the person with authority and, where needed, the customer? Look for: the approval record, the customer's agreement. (8.6 Release of products and services)
  3. 46Do labels, packaging and paperwork match the order and the customer's packaging requirements (part number, revision, quantity, lot)? Look for: the packing list against the order and the label, the customer packaging specification. (8.5.4 Preservation)

When to use it

  • When it is due on your audit programme, or after a change or a problem.
  • An auditor or leader answers each question from what they see, hear and read in the area.

How it is scored

The template is built with points per answer and a pass mark of 80. In this library every audit is set to pass at 80 and every inspection at 90. Each submitted audit shows its score and pass or fail, and every No is flagged with its photo and comment.

Change the points or the pass mark after you clone it. How rules and scoring work.

Read and print

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Use this template in LeanSuite

It is ready in the Template Marketplace inside Lean Creator as “ISO 9001 Internal Audit”. Clone it into your plant, change any question, then schedule it to a person, role or asset with reminders. Auditors complete it on a phone or tablet, with photo evidence where required.

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