ISO 9001:2015, 10.2

This article provides a summary of the ISO/DIS 9001:2015 requirements in Clause 10.2, Nonconformity and Corrective Action, and also identifies the changes from ISO 9001:2008.

10.2 Nonconformity and Corrective Action

10.2.1

When a nonconformity occurs, including those arising from complaints, the organization must react to the nonconformity, and as applicable, take action to control and correct it, as well as, deal with the consequences.

In addition, the organization must evaluate the need for action to eliminate the causes of the nonconformity so it does not recur elsewhere. This involves reviewing the nonconformity, determining its causes, and determining if similar nonconformities exist, or could potentially occur.

The organization must then implement any action needed, review the effectiveness of any corrective action taken, and make changes to the quality management system, if necessary.

The corrective actions must be appropriate to the effects of the nonconformities encountered.

Note 1: In some instances it can be impossible to eliminate the cause of a nonconformity.
Note 2: Corrective action can reduce the likelihood of recurrence to an acceptable level.

10.2.2

The organization must “retain” documented information as evidence of the nature of the nonconformities and any subsequent actions taken, as well as, evidence of the results of any corrective action.

Use of “retain” indicates the documented information refers to “records” kept as evidence.

Further changes may be introduced in the FDIS version, as well as, the final published version of the ISO 9001:2015 standard.

Changes from ISO 9001:2008

Clause Numbers

ISO/DIS 9001:2015 has adopted the new Annex SL clause structure required for all new and revised management system standards. Annex SL has clause 10 as “Improvement”, clause 10.1 as “Nonconformity and Corrective Action” and clause 10.2 as “Continual Improvement”.

Since ISO/DIS 9001:2015 has added a “General” section as clause 10.1, “Nonconformity and Corrective Action” has been bumped to clause 10.2 and “Continual Improvement” to clause 10.3.

The corrective action requirements in clause 8.5.2 of ISO 9001:2008 are now stated in clause 10.2 of the ISO/DIS 9001:2015 standard.

Corrective Action

The requirements in clause 10.2 of the draft ISO 9001:2015 are very similar to the requirements stated in ISO 9001:2008, clause 8.5.2.

The draft standard adds that the organization must react to a nonconformity by first controlling and correcting it, as well as, dealing with its consequences. It also adds a requirement to determine if similar nonconformities exist, or could potentially occur.

Another new requirement is to make changes to the quality management system, if necessary.

Clause 10.2.2 adds that the documented information retained as evidence must now indicate the nature of the nonconformity and any subsequent actions taken.

Documented Information

Clause 8.5.2 of ISO 9001:2008 requires a documented procedure for the corrective action process. Clause 10.2 of ISO/DIS 9001:2015 does not require a documented procedure.

Clause 8.5.2 refers to keeping records of the results of action taken. Clause 10.2.2 changes the requirement from keeping “records” to retaining “documented information” as evidence.

Preventive Action

The draft standard has dropped the concept of preventive action that is currently conveyed in clause 8.5.3 of ISO 9001:2008. It has been replaced by risk-based thinking, which is described in my October 2014 newsletter article on ISO/DIS 9001:2015, Clause 0.5.

Changes from Annex SL Common Text

The draft standard uses the common text of Annex SL for this clause almost without change. The only extra ISO/DIS 9001:2015 requirement text is the clarification that a nonconformity may arise from a complaint.

ISO/DIS 9001:2015 also adds two Notes that point out it can be impossible to eliminate the cause of a nonconformity, and that a corrective action can reduce the likelihood of recurrence to an acceptable level.