Nonconformity Corrective Action Procedure
The ISO Corrective Action Procedure outlines the responsibilities and methods for identifying causes of nonconformities in the QMS, initiating corrective action(s), and performing follow-up to ensure that those corrective action(s) have been effective in eliminating the nonconformities in an ISO 9001:2015 QMS.
This procedure applies to all QMS nonconformities, whether identified during Internal Quality Audits or Management Reviews, by way of customer feedback, or by Management in general. (11 pages, 1368 words)
Nonconformity Corrective Action Responsibilities:
Quality Management is responsible for ensuring that the corrective action procedures are accurate, understood, and implemented effectively.
The ISO Management Representative is also responsible for reporting on corrective actions taken at Management Review Meetings.
All Employees are responsible for investigating and recording the cause(s) of nonconforming conditions when those tasks are assigned to them and for implementing corrective actions determined by this process.
Nonconformity Corrective Action Definitions:
CAR – Corrective action request (or report).
Conform – Be in agreement; act according to prevailing standards or customs.
Correction – Action taken to rectify/repair a known nonconformity.
Corrective action – Act of eliminating the root cause of a known nonconformance, defect, or other undesirable situation to prevent its recurrence.
Nonconformity – output not conforming to a standard or specification; something that falls outside of defined critical limits; also known as “nonconformance” and includes complaints.
Root cause – Ultimate, or initiating, cause of an effect; usually identified through an exercise known as “root cause analysis”.
Nonconformity Corrective Action Procedure Activities
- Determining the Need for Corrective Action
- Initiating Corrective Action
- Investigating the Cause
- Taking Correction Action
- Verification and Closure
Nonconformity Corrective Action Procedure References
- ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sep., 2015 http://www.iso.org.
- Quality Procedures
- QP1020 Internal Audits
- QP1030 Nonconforming Output Control
- QP1060 Management Review
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