ISO 9001-2015 clause 10.2 is different from ISO 9001-2008 corrective action requirements, i tried to capture the updated requirements and with a suggested format for deal with the updated requirements.

1. ISO 9001-2015
Clause 10.2 Nonconformity and
corrective action.
By Raghu Malayanuru

2. ISO 9001-2015 clause 10.2
The text of ISO 9001-2015 clause 10.2:
“when a nonconformity occurs, the organization shall:
a) React to the nonconformity and, as applicable:
1) Take action to control and correct it;
2) Deal with the consequences, including mitigating adverse environmental impacts;
b) Evaluate the need for action to eliminate the causes of the nonconformity, in order that it does not recur or occur elsewhere, by:
1) Reviewing and analysing the nonconformity;
2) Determining the causes of the nonconformity;
3) 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, if necessary;
f) Make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 the organization shall retain documented information as evidence of:
a) The nature of the nonconformities and any subsequent actions taken;
b) The results of any corrective action.

3. ISO 9001-2015 clause 10.2
Let us discuss; how to deal with nonconformities:
If any nonconformity occurs
• react to the nonconformity; through correcting the NC, if the NC is shipped to the client or have
any effects on QMS, list out all the consequences and deal with each consequence (sometimes it
may have financial implications, penalties and loss of reputation etc..)
• Evaluate the action needed to eliminate the causes of NC; review the NC, find out the root cause,
(there are many tools to analyse and find out root cause), find out-if similar NCs exist, or
potentially occur.
• Implement actions needed; to eliminate root-cause
• Review the effectiveness of CA taken; to ensure that the NC does not recur/occur.
• Update the risks and opportunities determined; there are possibilities that the risk related to this
NC has not been determined, or the impact / consequence evaluation may need update, or we
may have to revise the frequency of this risk occurrence etc..
• Make changes to QMS – may be it requires change in documentation requirement, may decide
new retained documents (Records); new frequency of monitoring and measurement etc.

4. ISO 9001-2015 clause 10.2
Let us discuss; how should be a format of NC and Corrective action:
Nonconformity and Corrective Action Report
Ref. # NCR # & Date:
Function/Location: (1) Design, (2) Purchase, (3) Production /
Service (4) QC (5) Stores/warehouse (6) HR
NCR identified during (1) IA, (2) Process, (3) Product, (4)Storage, (5) Handling,
(6) Outsourced (7) Drawing, (8) Other
Clause attribution (ISO 9001-2015) / Specification reference / Process reference:
Details of Nonconformity:
Consequences & Effects of NC: Responsibility to deal with
consequences:
Correction / Mitigation: Responsibility for correction & Evidence of correction taken:
Analysis of the Nonconformity:
(refer annexure 1 for detailed analysis of
NC)
Root cause identified: Details of similar NCs exist elsewhere
or could potentially occur:
Attach documents, if required to evidence the analysis, root
cause and determination of similar NCs elsewhere in the
organization.
Corrective action taken: Evidence of CA implemented:
Risks / Opportunities updated: □Yes □Not applicable
(if yes, give reference of document updated)
Change in any Documented information: □Yes □Not applicable
(if yes, give reference of document changed/revised/initiated)
Effectiveness of CA taken:
Verified by: Approved by: