Clause 8.9: Management reviews
The required inputs and outputs of a management review, the findings assessors write most often, and the checklist that prevents them.
What the clause asks for
Clause 8.9 requires laboratory management to review its management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness, including the policies and objectives related to the standard (8.9.1).
Clause 8.9.2 lists the inputs that are recorded, in summary: changes in internal and external issues relevant to the laboratory; fulfilment of objectives; suitability of policies and procedures; status of actions from previous reviews; the outcome of recent internal audits; corrective actions; assessments by external bodies; changes in the volume and type of work or the range of activities; customer and personnel feedback; complaints; effectiveness of implemented improvements; adequacy of resources; results of risk identification; outcomes of the assurance of the validity of results; and other relevant factors such as monitoring activities and training.
Clause 8.9.3 requires the outputs to be recorded, including decisions and actions related to the effectiveness of the management system and its processes, improvement of laboratory activities related to fulfilment of the standard, provision of required resources, and any need for change.
What assessors sample
Assessors read the most recent minutes against the 8.9.2 list and check that each input was actually discussed, not just listed, then look for the actions that came out of the review and whether they were followed up at the next one. Common findings:
- One or more required inputs missing from the minutes.
- Outputs with no owner or date.
- Reviews further apart than the laboratory’s own procedure allows.
Where this lives in AccreditBook
| Requirement | Field in AccreditBook |
|---|---|
| Planned interval (8.9.1) | Next review due, which feeds the due list |
| Inputs (8.9.2) | Inputs checklist with one line per required input, each marked covered with a note |
| Outputs (8.9.3) | Outputs section for each required output, decisions, actions summary |
| Attendance and record | Held on, attendees, minutes upload |
| Approval | Status from scheduled to held to minutes approved |
The inputs checklist makes it visible before the meeting closes if an input has been missed. Audit results, corrective actions and PT outcomes for the period are already in AccreditBook, so preparing the inputs is a matter of reading the dashboard and the relevant lists rather than collecting them from several files.
See Management review, Internal audits and Corrective actions.
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