5.4 Clause 10 — Improvement
Key Takeaways
- Clause 10.1 requires organizations to determine and select improvement opportunities and implement necessary actions to meet requirements and enhance customer satisfaction.
- Clause 10.2 distinguishes correction, which fixes the immediate nonconformity, from corrective action, which eliminates its root cause so it does not recur — auditors must probe for both.
- Clause 10.2.1(b) requires evaluating the need for corrective action through root-cause analysis, including checking whether similar nonconformities exist elsewhere or could occur.
- Corrective action must be reviewed for effectiveness, and, where relevant, risks/opportunities and the QMS itself updated as a result.
- Clause 10.3 requires continual improvement of the QMS's suitability, adequacy and effectiveness, drawing specifically on clause 9.1 analysis results and clause 9.3 management review outputs.
Clause 10 is the Act step of the PDCA cycle: having checked the QMS through clause 9, the organization must now respond. It has three sub-clauses, but the exam and real audit practice concentrate overwhelmingly on 10.2, nonconformity and corrective action -- the clause every auditor writes findings against, and the clause you will apply directly when drafting nonconformity statements in Chapter 8.3.
10.1 General
Clause 10.1 sets the frame: the organization shall determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction. This shall include:
- Improving products and services to meet requirements as well as address future needs and expectations
- Correcting, preventing or reducing undesired effects
- Improving the performance and effectiveness of the QMS
Improvement, in other words, is not limited to fixing problems after the fact -- it explicitly includes proactive improvement and anticipation of future needs, linking back to the risk-based thinking introduced in Chapter 1.5.
10.2 Nonconformity and Corrective Action
This is the clause with the most exam and audit weight. Clause 10.2.1 sets out what must happen when a nonconformity occurs, including one arising from a complaint:
- (a) React to the nonconformity: take action to control and correct it, and deal with the consequences
- (b) Evaluate the need for action to eliminate the cause(s) of the nonconformity, so that it does not recur or occur elsewhere, by:
- Reviewing and analyzing the nonconformity
- Determining the causes of the nonconformity
- Determining if similar nonconformities exist, or could potentially occur
- (c) Implement any action needed
- (d) Review the effectiveness of any corrective action taken
- (e) Update risks and opportunities determined during planning (Clause 6.1), if needed
- (f) Make changes to the QMS, if needed
The clause closes with a proportionality statement: corrective actions shall be appropriate to the effects of the nonconformities encountered. A minor, one-off clerical error does not warrant the same root-cause investigation as a systemic failure affecting product safety.
Correction vs. Corrective Action: The Distinction That Matters Most
This is the single most heavily examined concept in Clause 10, and it is central to writing a defensible nonconformity statement:
| Term | What it addresses | Example |
|---|---|---|
| Correction | The immediate nonconformity itself, step (a) | Reworking an out-of-tolerance batch; scrapping defective units; re-issuing a wrong document |
| Corrective action | The root cause of the nonconformity, steps (b) through (d) | Investigating why the calibration was missed, retraining staff, and revising the calibration schedule so it cannot be missed again |
A correction without corrective action fixes today's problem and lets it recur next month. An auditor who finds the same nonconformity, or a close variant of it, reappearing across multiple internal audits or production runs should treat that recurrence as strong objective evidence that corrective action under 10.2.1(b) through (d) was inadequate or never genuinely performed, even if a "corrective action" form was completed on paper.
Root-Cause Analysis Techniques
Clause 10.2.1(b) does not mandate a specific method, but candidates should recognize the common tools organizations use to satisfy "determining the causes":
- 5 Whys -- repeatedly asking "why" to trace a symptom back to its underlying cause
- Fishbone (Ishikawa) diagrams -- categorizing potential causes across people, process, equipment, materials, and environment
- Pareto analysis -- identifying the small number of causes responsible for the majority of nonconformities
Steps (e) and (f) of clause 10.2.1 are easy to overlook but matter for exam scenarios: if a corrective action investigation reveals a risk that was not previously identified in the organization's clause 6.1 risk register, the register itself must be updated, and if the corrective action changes a process, the QMS documentation must be revised to match it. A corrective action that fixes the process on the shop floor but leaves the written procedure unchanged has only partially satisfied clause 10.2.1 -- the practice and the documented information have drifted apart.
10.2.2 Documented Information
The organization must retain documented information as evidence of the nature of the nonconformities and any subsequent action taken, and the results of any corrective action. In practice this is a nonconformity and corrective action record or log -- the primary artifact a lead auditor reviews to test clause 10.2 conformity across a sample of past events, not just the current audit period.
10.3 Continual Improvement
Clause 10.3 requires the organization to continually improve the suitability, adequacy and effectiveness of the QMS, explicitly instructing it to consider the results of analysis and evaluation from clause 9.1 and the outputs from management review under clause 9.3 to determine whether there are needs or opportunities to be addressed as part of continual improvement. This closes the loop of the whole chapter: data from 9.1 feeds decisions in 9.3, and both feed the ongoing improvement obligation in 10.3, so the QMS is meant to be a system that gets better over time rather than a static set of documents.
Auditing Clause 10
Objective evidence to request includes the nonconformity and corrective action log or database, a sample of individual records showing correction, root-cause analysis, implemented action and an effectiveness review, and evidence that recurring or systemic issues triggered escalation rather than repeated identical corrections. When you reach Chapter 8.3 and learn to write a nonconformity statement, remember that the requirement you cite is frequently drawn straight from clause 10.2 -- and the strongest statements distinguish clearly between what was corrected and what, if anything, was done about the cause.
A batch of parts is found out of tolerance. The team reworks the batch to bring it into specification and releases it. Three months later, the same defect recurs on a different batch from the same machine. What does this recurrence indicate about the organization's clause 10.2 process?
Per ISO 9001:2015 clause 10.2.1(b), after reacting to and correcting a nonconformity, what must an organization do before it can validly conclude that no further action is required?