Laboratory Management System (LMS)
This domain tests how the LMS is documented, maintained and improved under clause 8, and how the laboratory chooses between Option A and Option B.
Option A and Option B
- Option A: the laboratory establishes and maintains a management system in accordance with clauses 4–7 and 8.1–8.9.
- Option B: the laboratory has a management system in accordance with ISO 9001 and also meets clauses 8.2–8.9; it must still meet clauses 4–7.
- The choice affects the documentation and audit trail, not the technical competence requirements.
Documented information and control
Clause 8.2 covers management system documentation; 8.3 covers control of management system documents; 8.4 covers control of records. Records must be legible, protected, retrievable and retained for specified periods. The 2017 standard uses ‘documented information’ rather than ‘documents and records’. Clause 8.5 requires actions to address risks and opportunities proportionate to the potential impact on results; a formal risk register is not mandatory. Clause 8.6 covers improvement, 8.7 corrective action, 8.8 internal audits and 8.9 management review.
Worked example
A laboratory holds a management review every 18 months and covers only complaints. The assessor checks 8.9.2 inputs: changes, fulfilment of objectives, suitability of policies and procedures, previous reviews, internal and external audits, corrective actions, external assessments, proficiency testing results, customer feedback, complaints, recommendations and resources. The record shows most inputs are absent. The nonconformity is against 8.9 because the review did not cover the required inputs, not because of the 18-month interval. The interval is set by the laboratory, since 8.9.1 requires planned intervals but does not fix them.
Traps
- Saying management review must be annual; no fixed interval is stated.
- Saying all clauses must be internally audited every year.
- Confusing correction (fixing the problem) with corrective action (addressing root cause).
- Assuming 8.5 requires a formal risk register.
- Choosing Option B and dropping clauses 4–7.