Corrective action and CAPA
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.
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Related terms
ENFSI (European Network of Forensic Science Institutes)ILAC MRA (International Laboratory Accreditation Cooperation Mutual Recognition Arrangement)ISO/IEC 17025:2017Management reviewMeasurement uncertaintyMethod validationNABL (National Accreditation Board for Testing and Calibration Laboratories)Proficiency testing (PT)SWGDRUG