Laboratory Management System (LMS)
This domain tests how the laboratory management system requirements in Clause 8 are established and kept effective. Questions focus on documentation, records, risk, improvement, corrective action, internal audit, management review, and how operational evidence feeds these activities.
What the LMS must deliver
Clause 8 requires a management system capable of supporting and demonstrating consistent fulfillment of ISO/IEC 17025 requirements and assurance of result quality. The laboratory must establish, document, implement, maintain and improve it. Policies and objectives show top management commitment; documentation must be communicated, understood and available where needed. A laboratory may use a management system aligned with ISO 9001, but it must still meet all ISO/IEC 17025 requirements.
Control, risk and review
Clause 8.3 controls management system documents: approval, review, version status and availability. Clause 8.4 controls records: legibility, retrieval, protection and retention. Clause 8.5 requires actions to address risks and opportunities affecting result validity; a formal risk register is not mandated. Clause 8.6 covers improvement, 8.7 corrective actions, 8.8 internal audits and 8.9 management reviews. Corrective action must address root cause and verify effectiveness, not merely fix the symptom.
Worked example
An internal audit finds that balances in one room were not calibrated because the equipment list omitted them. The correction is to calibrate or quarantine those balances immediately. The corrective action is to investigate why the inventory process missed them, update the inventory, assign responsibility, and check at a later audit whether the updated process prevents recurrence. The reasoning is that Clause 8.7 separates correction from corrective action and requires effectiveness review; closing the action after calibration alone would leave the system weakness in place.
Traps that cost marks
Do not confuse documents with records; documents are controlled for current use, records are retained evidence. Do not treat internal audit as an external accreditation inspection or management review as a meeting with no required inputs and outputs. Avoid corrective action plans that lack root cause or effectiveness checks, and do not reduce risk management to a separate binder unrelated to laboratory processes.