Module
Laboratory Management
Internal or partner lab operates with demonstrated competence, impartiality and traceability.
Module details
ExpertStage: Cross-stage
Outcome: Internal or partner lab operates with demonstrated competence, impartiality and traceability.
Roles
- Lab Manager
- Quality Head
Workflow
- 1.Maintain method scope and equipment register
- 2.Run calibration and inter-lab checks on schedule
- 3.Control environment, sample handling and records
- 4.Review non-conforming work and improvement actions
Evidence
Common failures
- Overdue calibration in active use
- Unqualified analyst releasing results
Escalation
Any impartiality risk is disclosed and reviewed by senior management before result release.
KPIs
- On-time calibration %
- Proficiency-test pass rate
Official sources
- ISO/IEC 17025 — Testing and calibration laboratories (ISO/IEC 17025:2017)
General requirements for the competence, impartiality and consistent operation of testing and calibration laboratories.
International Organization for Standardization / IEC · Authority: ISO
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