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.
Related terms
- ENFSI (European Network of Forensic Science Institutes)
- The umbrella organisation representing public forensic science laboratories across Europe. Develops best practice manuals for forensic disciplines, runs proficiency testing schemes, and...
- ILAC MRA (International Laboratory Accreditation Cooperation Mutual Recognition Arrangement)
- An agreement among national accreditation bodies (NABL, A2LA, UKAS, DAkkS, etc.) under which accreditation by any signatory body is recognised as equivalent,...
- ISO/IEC 17025:2017
- The international standard specifying general requirements for the competence of testing and calibration laboratories. Covers management (document control, non-conforming work, audits) and...
- Management Review
- The annual governance meeting required under ISO 17025 Clause 8.9, at which laboratory management reviews the aggregated quality performance data (PT results,...
- Measurement Uncertainty
- A quantitative statement of the range within which the true value of a measurement lies, at a stated confidence level (typically 95%,...
- Method Validation
- The process of demonstrating that an analytical method does what it claims: that it correctly identifies the target analyte, at what sensitivity,...
- NABL (National Accreditation Board for Testing and Calibration Laboratories)
- India's ISO 17025 accreditation body, operating under DPIIT and signatory to the ILAC MRA since 2001. Accredits CFSLs and SFSLs for specific...
- Proficiency Testing (PT)
- A quality assurance mechanism in which laboratories analyse blind samples distributed by an external scheme coordinator and have their results compared against...
- SWGDRUG
- Scientific Working Group for the Analysis of Seized Drugs, established in 1997 by the US DEA and the Office of National Drug...
Explained in
- ISO 17025, NABL, ENFSI and Quality Systems for Forensic Chemistry LaboratoriesThe ISO 17025 Clause 8.7 requirement for root-cause analysis and documented corrective and preventive action (CAPA) following any nonconformity (PT failure, IQ...