ISO 13485 Nonconformance Report
Use this ISO 13485 nonconformance report template to record what failed, how it was contained, what happens to the product and whether a CAPA is needed. It is written for medical device manufacturers and exports to PDF or Word.
Fill in
ISO 13485 Nonconformance Report Template with Disposition and CAPA Link
Nonconformance Report
Meridian Medical Components Inc NCR number: NCR-2026-0147 Date raised: 2026-10-20 Part / device: LG5-204 Jaw insert Lot / serial: Lot 26-1142 Quantity affected: 240 of 1,200 pieces Found at: In-process
Description of nonconformance
Jaw tooth height measured 0.46 mm against drawing requirement 0.50 mm plus or minus 0.03 mm on 6 of 30 sampled pieces at operation 40. Gauge and calibration status verified.
Immediate containment
Lot quarantined in red-tag area. All stock at operation 40 and downstream segregated and tagged. Previously shipped lots from the same tool reviewed: none shipped.
Health hazard and risk assessment
| Question | Answer | Reference |
|---|---|---|
| Could the nonconformance affect safety or performance? | Risk file | |
| Are other lots or devices potentially affected? | Traceability records | |
| Is any product already shipped or implanted? | Distribution records | |
| Is a customer or regulatory notification needed? | Vigilance procedure |
Disposition
Decision: Re-inspect and sort
Use as is by concession is only allowed where regulatory requirements are met, a justification is recorded and the authorizing person is identified. Rework must follow a documented, approved procedure and the reworked product must be re-verified against the original acceptance criteria.
Disposition actions and verification
| Action | Owner | Date | Record / result |
|---|---|---|---|
| Sort 100 percent for tooth height | |||
| Segregate and scrap nonconforming pieces | |||
| Verify accepted pieces per inspection plan | |||
| Update device history record |
Root cause and CAPA link
CAPA decision: Yes, CAPA opened CAPA number: CAPA-2026-031
Preliminary cause (to be confirmed in the CAPA):
Approvals
Starting template, not a controlled form. Align field names and approval roles with your own nonconforming product procedure. ISO 13485 requires control of nonconforming product, including records of the nature of the nonconformity, actions taken and any concession with the person authorizing it. Regulations such as FDA 21 CFR 820 may add further requirements.
NCR trend review from your own data
Optional: we can trend your NCR and CAPA records by cause and process, kept on your servers.
Optional. The tool and every export work without this. No spam.
How to fill in the NCR
Raise the NCR as soon as nonconforming product is found and contain it before you investigate. Describe the nonconformance in measurable terms: requirement, actual result, sample size and the gauge used. Record the lots and serial numbers so traceability can answer where else the problem may exist. Complete the risk questions before choosing a disposition, since the answers decide whether a concession is acceptable at all. Finally decide whether a CAPA is needed and enter its number so the two records can be found from each other.
- Always contain first, then investigate
- State the requirement and the measured value
- Identify lots, serials and shipped product
- Link the CAPA number in both records
What ISO 13485 expects
Clause 8.3 requires a documented procedure for controlling nonconforming product so that it is identified and kept from unintended use or delivery. Records must show the nature of the nonconformity and any action taken, including concessions and who authorized them. Before delivery, you can eliminate the nonconformity, prevent the intended use, or release by concession where regulations allow. Rework needs a documented procedure that takes account of possible adverse effects, and product must be re-verified after rework. Product found after delivery needs action appropriate to its effects.
Deciding when a CAPA is needed
Not every NCR needs a CAPA. A one-off damaged part with an obvious cause may be closed on its own. Open a CAPA when the issue repeats, when the cause is not understood, when safety or performance may be affected, or when a customer or regulator is involved. Record your justification either way. Trend NCRs by cause and process so recurring problems surface; a Pareto of NCRs by cause usually finds the next CAPA.
Common mistakes
Using scrap as the default disposition without checking for other affected lots, approving use as is without a documented justification, rework with no approved procedure, and closing the NCR before the verification record exists. Also avoid blaming the operator in the cause field; the CAPA is where cause is established.
Frequently Asked Questions
What must an ISO 13485 NCR record?
The nature of the nonconformity, the actions taken including any concession, and the identity of the person who authorized the concession. In practice also record part and lot, quantity, containment, disposition, verification and the link to any CAPA.
Can nonconforming product be used by concession?
Only if regulatory requirements are met and the use is justified and authorized by an identified person. Many companies bar concession for safety-critical characteristics. Always document the risk assessment behind the decision.
What is the difference between an NCR and a CAPA?
An NCR deals with the affected product: contain it, decide its disposition and record it. A CAPA deals with the cause: find it, correct it, prevent recurrence and verify effectiveness. One CAPA can cover many NCRs.
Does rework need special controls?
Yes. ISO 13485 expects a documented rework procedure that considers adverse effects, approval like the original process, and re-verification so the product conforms to its acceptance criteria. Record the rework in the device history record.
If NCR data sits in your ERP and quality system, we can add a private AI layer on your own servers to trend causes and draft CAPA candidates for human review.
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