Corrective Action and CAPA
Definition
The ISO 17025 Clause 8.7 requirement for root-cause analysis and documented corrective and preventive action (CAPA) following any nonconformity (PT failure, IQC failure, audit finding, customer complaint). The CAPA record is the primary audit trail demonstrating the quality management system is operational rather than administrative.
- Standard clause
- ISO 17025 Clause 8.7
- Trigger events
- PT failure, IQC failure, audit finding, complaint
- Core requirement
- Root-cause analysis plus documented action
- Audit role
- Primary trail showing the QMS is active, not administrative
Common questions
Why do auditors treat the CAPA record as more telling than the policy manual?+
A policy manual only states intent, while a CAPA record shows whether the lab actually investigated a real nonconformity, identified its root cause, and closed it out, which is the practical evidence that the quality system functions day to day.
What is the difference between a corrective action and a preventive action in CAPA?+
A corrective action addresses a nonconformity that has already occurred and its root cause, while a preventive action addresses a potential nonconformity identified before it occurs, so the two entries in a CAPA log serve different points in the failure timeline.
Related terms
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