ISO 9001 Clause 8.7 and 10.2: Control of Nonconforming Output and CAPA
Most ISO 9001 nonconformities trace back to a single confusion: treating the act of fixing a defective product as if it were corrective action. Clause 8.7 and Clause 10.2 describe two different obligations, and auditors regularly find organizations that satisfy the first while quietly skipping the second. The result is a quality system that contains and reships defective output without ever asking why the defect happened — and the same finding returns at the next surveillance audit.
If your quality records show a healthy volume of nonconformity reports but a thin trail of root cause analysis and effectiveness verification, you are carrying audit exposure that looks fine on a spreadsheet. This article breaks down what each clause actually requires, where the two connect, and how to build a workflow that closes the loop.
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What ISO 9001 Clause 8.7 Requires: Control of Nonconforming Output
Clause 8.7 is the operational containment requirement. It governs what you do with output — products or services — that does not meet requirements, with the single goal of preventing its unintended use or delivery to the customer.
The clause does not ask why the nonconformity happened. That belongs to Clause 10.2. Clause 8.7 is concerned only with controlling the defective output that exists right now. Per ISO 9001:2015, the organization must deal with nonconforming output through one or more of the following dispositions:
| Disposition | What it means | Example |
|---|---|---|
| Correction | Repair or rework so the output meets requirements | Re-machine a part to spec |
| Segregation / containment | Physically isolate the output to prevent its use | Quarantine a defective lot |
| Return / suspension | Halt provision of the product or service | Recall shipped units |
| Informing the customer | Disclose the nonconformity to the affected party | Notify the client of a deviation |
| Concession | Obtain authorization for acceptance "as is" | Accept under documented waiver |
Two requirements inside 8.7 catch organizations most often:
- Re-verification after correction. When you correct a nonconforming output, you must verify it against requirements again before release. Reworking a part and shipping it without re-inspection is a direct 8.7 nonconformity.
- Documented evidence. Clause 8.7.2 requires you to retain documented information describing the nonconformity, the actions taken, any concessions, and the authority that decided the disposition. A verbal "we scrapped it" does not satisfy the clause.
Clause 8.7 lives in the operational stage of the standard (Clause 8, Operation). It is reactive and immediate by design. It stops bad output from reaching the customer — but it does nothing to stop the next batch from being defective. That is precisely the boundary where Clause 10.2 takes over.
What ISO 9001 Clause 10.2 Requires: Nonconformity and Corrective Action
Clause 10.2 is the improvement requirement. It governs the analysis of why a nonconformity occurred and the action taken to prevent it from happening again. Where 8.7 contains the symptom, 10.2 eliminates the cause.
Clause 10.2 sits in Clause 10, Improvement — the back end of the standard's Plan-Do-Check-Act cycle. When a nonconformity occurs, including one arising from a complaint, the standard requires the organization to:
- React to it. Control and correct the nonconformity, and deal with the consequences. (This overlaps with the 8.7 disposition.)
- Evaluate the need for corrective action. Review and analyze the nonconformity, then determine its causes and whether similar nonconformities exist or could occur elsewhere. Not every nonconformity demands a full corrective action — but the decision must be documented.
- Implement any action needed. Take corrective action to address the root cause.
- Review the effectiveness of any corrective action taken.
- Update risks and opportunities, and the QMS, if necessary.
The standard also requires you to retain documented information as evidence of the nature of the nonconformities and any subsequent actions taken, plus the results of any corrective action.
Two steps inside 10.2 generate the bulk of audit findings:
- Root cause determination. The clause requires you to "determine the causes." A documented cause of "operator error" or "did not follow procedure" almost never survives auditor scrutiny, because it stops at the symptom and leads to retraining that does not prevent recurrence.
- Effectiveness review. You must verify that the corrective action actually worked — not merely that it was completed. Closing a corrective action on the day it is assigned, instead of the day it is confirmed effective, is one of the most frequently cited Clause 10.2 nonconformities.
For a deeper walkthrough of the full corrective action lifecycle under this clause, see our ISO 9001 corrective action guide.
How Clause 8.7 and Clause 10.2 Connect
The two clauses describe a single workflow split across two stages: contain, then improve. Confusing them is the most common structural defect in a quality management system.
A clean way to hold the distinction:
| Clause 8.7 | Clause 10.2 | |
|---|---|---|
| Question it answers | What do we do with this defective output? | Why did this happen, and how do we stop it? |
| Stage in the standard | 8 — Operation | 10 — Improvement |
| Timing | Immediate / reactive | Investigative / preventive |
| Output | Disposition decision + re-verification | Root cause + corrective action + effectiveness review |
| Trigger for the next | Always required when output is nonconforming | Required only when corrective action is warranted |
The connection runs in one direction. Every Clause 10.2 corrective action begins with a Clause 8.7 event (or a complaint, audit finding, or process deviation). But not every 8.7 event escalates to a full 10.2 corrective action — the standard explicitly requires you to evaluate the need. A single isolated defect dispositioned and re-verified may close at 8.7. A recurring defect, a high-severity one, or a pattern across multiple lots should trigger 10.2.
Two failure modes follow from blurring the line:
- Stopping at 8.7. The organization quarantines, reworks, and reships, then closes the record. No cause is determined, so the defect returns. Auditors flag this as a Clause 10.2 gap — the QMS reacts but does not improve.
- Over-triggering 10.2. The organization opens a formal corrective action for every minor deviation, overwhelming the process. Owners stop responding to notifications, due dates slip, and the system fatigues. The standard does not require a corrective action for every nonconformity — only a documented decision about whether one is warranted.
The discipline is in matching the response to the severity and recurrence of the nonconformity, and in making the handoff from 8.7 to 10.2 a deliberate, recorded decision rather than an afterthought.
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The Audit Findings Auditors Cite Most Often
Certification auditors examine both the documented procedure and the evidence that it is actually being used. For Clause 8.7 and 10.2, the gap between the two produces a predictable set of findings.
The most common deficiencies, grouped by clause:
Clause 8.7 findings
- Corrected output released without documented re-verification against requirements.
- Concessions accepted without recorded authority for the decision.
- No retained documented information describing the nonconformity and its disposition.
- Nonconforming material found in production areas without segregation or status identification.
Clause 10.2 findings
- Corrective action closed on the assignment date, with no effectiveness review.
- Root cause recorded as "human error" without examining the conditions that allowed it.
- Repeat nonconformities — the same finding across multiple audit cycles — indicating prior corrective actions were closed without resolving the cause.
- Corrective actions implemented but the QMS, risks, and opportunities never updated to reflect the change.
Recurring nonconformities with completed-but-ineffective corrective actions are the most damaging pattern, because they call the organization's entire continual improvement process into question. A strong closure rate paired with high recurrence tells an auditor the system is completing paperwork, not preventing problems.
The compliance stakes extend beyond the certificate. Where a quality nonconformity also has a safety dimension — a defective output that creates a workplace hazard — an ineffective corrective action can attract regulatory attention. As of 2026, OSHA's maximum penalty is $16,550 per serious violation and $165,514 per willful or repeated violation, following the annual inflation adjustment effective January 15, 2025. A "repeated" classification is exactly the regulatory analogue of the repeat-finding pattern auditors flag under Clause 10.2.
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Building a Workflow That Satisfies Both Clauses
The difference between a clean audit and a clutch of findings is rarely the quality of any single corrective action plan. It is whether the workflow enforces the steps that 8.7 and 10.2 require — instead of relying on people to remember them.
A workflow that satisfies both clauses has these elements:
- A disposition step with re-verification (8.7). Every nonconforming output gets a recorded disposition and, where corrected, a mandatory re-inspection field before the record can advance. The authority for the decision is captured by name.
- A documented escalation decision (8.7 → 10.2). A required field asks whether corrective action is warranted, with a brief justification. This satisfies the "evaluate the need" requirement and creates the audit trail for both "yes" and "no" decisions.
- Structured root cause analysis (10.2). Methods like 5 Whys or fishbone push the investigation past the first plausible answer. The record should capture the chain, not just a one-line cause.
- Corrective actions with named owners and due dates (10.2). A single accountable person — not a department — owns each action, with a documented deadline tiered by severity.
- A required effectiveness review (10.2). The record cannot close until a follow-up review, scheduled at a defined interval after implementation, confirms the corrective action eliminated the cause and the nonconformity has not recurred.
- A QMS-update prompt (10.2). When a corrective action reveals a process or document gap, the workflow links to the relevant procedure, risk register, or competence record so the management system stays current.
The single most valuable design choice is making the effectiveness review a gate rather than an option. When the record is structurally un-closeable until verification is documented, the most common Clause 10.2 finding disappears — not because people became more diligent, but because the system stopped letting them skip the step.
Beyond individual records, trend analysis across nonconformity data is where systemic improvement appears. Recurring nonconformities on the same equipment, process, or product line are signals about the management system that no single corrective action will surface. This is also the input the standard expects you to feed into management review.
Frequently Asked Questions
Q. What is the difference between Clause 8.7 and Clause 10.2 in ISO 9001?
Clause 8.7 controls nonconforming output — it governs the immediate disposition (correction, segregation, return, concession) to prevent defective products or services reaching the customer. Clause 10.2 governs nonconformity and corrective action — determining the root cause and acting to prevent recurrence. In short: 8.7 contains the symptom, 10.2 eliminates the cause.
Q. Does every nonconformity require a corrective action under Clause 10.2?
No. Clause 10.2 requires you to evaluate the need for corrective action and document that decision. A single isolated, low-severity nonconformity may be fully resolved through Clause 8.7 disposition and re-verification. Recurring, high-severity, or systemic nonconformities should trigger a full Clause 10.2 corrective action.
Q. What does "review the effectiveness of corrective action" mean?
It means verifying — at a defined interval after implementation — that the corrective action actually eliminated the root cause and the nonconformity has not recurred. Recording that an action was completed is not the same as confirming it worked. Closing a corrective action before this review is one of the most frequently cited Clause 10.2 nonconformities.
Q. Is re-verification mandatory after correcting nonconforming output?
Yes. Clause 8.7 requires that when nonconforming output is corrected, it must be verified against requirements again before release. Reworking and shipping without documented re-inspection is a direct Clause 8.7 finding.
Q. What documented information do Clause 8.7 and 10.2 require?
Clause 8.7.2 requires records of the nonconformity, the actions taken, any concessions, and the authority deciding the disposition. Clause 10.2.2 requires evidence of the nature of the nonconformities, subsequent actions, and the results of any corrective action.
Key Takeaways
- Clause 8.7 (Operation) controls nonconforming output through disposition and re-verification; Clause 10.2 (Improvement) determines root cause and takes corrective action. Confusing the two is the most common structural QMS defect.
- Every Clause 10.2 corrective action starts with an 8.7 event, but not every 8.7 event escalates — the standard requires a documented decision about whether corrective action is warranted.
- The two findings auditors cite most are corrected output released without re-verification (8.7) and corrective actions closed without an effectiveness review (10.2).
- Recurring nonconformities with completed-but-ineffective actions are the most damaging pattern, calling the entire continual improvement process into question — and the regulatory analogue is OSHA's "repeated" violation classification ($165,514 maximum as of 2026).
- A workflow that gates closure on documented effectiveness verification eliminates the most common Clause 10.2 finding by design, not by diligence.
Related Resources
| Resource | Description | Best For |
|---|---|---|
| ISO 9001 Corrective Action: Full Guide | The complete Clause 10.2 corrective action lifecycle from finding to closure | Quality managers building or auditing a corrective action procedure |
| Corrective Action Management: Stop Losing Track of Your CAPA Items | Why CAPA items fall through the cracks and how to build a system that closes them on time | EHS and quality managers with open-action backlogs |
| AI in Root Cause Analysis | Where AI adds value in investigation workflows behind Clause 10.2 | Teams scaling root cause quality across multiple sites |
Sources:
- ISO 9001:2015 Requirements 8.7 and 10.2 — QMS Certification
- ISO 9001 Clause 10.2 Nonconformity and Corrective Action — Auditor Training Online
- 8.7 Control of Nonconforming Outputs — ISO 9001 Checklist
- OSHA Penalties — Occupational Safety and Health Administration
- US Department of Labor announces adjusted OSHA civil penalty amounts — OSHA