ISO 15189:2022 · Section 8 · Management system requirements
Clause 8.9: Management reviews
Check the exact requirement in your licensed copy of the standard.
Last reviewed
What this clause is about
Management review is the leadership process for deciding whether the laboratory management system remains suitable, adequate and effective. It brings operational evidence together so that leaders can judge performance, changing needs and resource priorities. A meeting that only reads activity totals does not achieve this purpose. The review should connect information to decisions about services, risks, objectives and the ability to deliver reliable patient care.
Prepare information that supports judgement rather than overwhelming participants with unfiltered reports. Consider progress on previous actions, achievement of objectives, significant internal and external changes, evaluation results, complaints, user and staff feedback, nonconformities, corrective actions and improvement activity. Review resources, workload, personnel capability, supplier performance and the effectiveness of risk controls where relevant. Include technical assurance such as quality control and external comparison outcomes, together with continuity concerns and important clinical communication issues.
Laboratory leadership should examine relationships between these inputs. Increased workload, delayed maintenance and rising turnaround times may together indicate a resource constraint that separate reports obscure. Record the conclusions reached, including why the system is considered adequate or where changes are required. Outputs should identify decisions, actions, owners, resources and follow-up arrangements. An issue requiring support from a parent organization needs a clear escalation route rather than repeated notation that it remains unresolved.
Plan reviews at appropriate intervals and retain evidence of the information considered and resulting decisions. Communicate relevant outcomes to personnel and track completion, including checks that major decisions delivered their intended effect. LabToolkit Pro can support agenda templates, review records, controlled objectives and action forms, but leadership must engage with the evidence, make defensible decisions and provide the resources needed to maintain effective laboratory services.
What assessors typically ask to see
- How does leadership determine whether the management system remains suitable, adequate and effective rather than merely reviewing activity statistics?
- Do review inputs cover previous actions, objectives, changing circumstances, evaluation results, feedback, failures, resources and improvement needs?
- How are technical performance and patient-service consequences considered alongside administrative or financial information?
- Can a significant review decision be traced to supporting evidence, an accountable owner, required resources and planned follow-up?
- How are relevant outcomes communicated to staff and unresolved resource or service concerns escalated to the appropriate authority?
Documents and records that usually provide evidence
- Management-review procedure defining leadership participation, planned intervals, required information, decision records and follow-up responsibilities.
- Prepared review inputs summarizing objectives, changes, risks, evaluations, technical assurance, feedback, resource needs and prior action status.
- Review minutes recording conclusions about system suitability, adequacy and effectiveness with the evidence informing significant decisions.
- Action register identifying owners, agreed dates, resource commitments, escalation arrangements and progress against review decisions.
- Communication records showing that relevant review outcomes and resulting service changes were explained to affected laboratory personnel.
- Subsequent reviews confirming completion of previous actions and evaluating whether important decisions delivered their intended operational benefits.
Ready-made forms mapped to clause 8.9: Management Calendar, Management Review Input Form, Management Review Agenda, Management Review Minutes, Management Review Action Plan.
Common findings to avoid
- Treating a routine operations meeting as management review without addressing system effectiveness, changing needs or resource adequacy.
- Presenting repeated audit and complaint summaries without discussing trends, linked causes or decisions about further action.
- Recording actions such as improve staffing without an accountable owner, defined next step or route to resource approval.
- Carrying the same unresolved action through successive reviews without escalation, revised planning or evaluation of ongoing patient risk.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 8.9 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 8.9 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Must management review occur in one meeting?
It can be organized through a coordinated sequence of reviews if the combined process covers the necessary information and produces coherent conclusions and actions. Preserve traceability so that important topics and overall system effectiveness are not lost between meetings.
Who should take part?
Include laboratory leadership and people able to explain performance, authorize changes and address resource needs. Invite relevant technical, quality or support personnel according to the agenda. Ensure decisions do not depend on attendees who lack the necessary authority.
What makes review records useful?
They show what evidence was considered, what leadership concluded and what will happen next. Clear ownership, deadlines, resource decisions and follow-up make the record actionable; a list of presentations alone does not demonstrate meaningful review.
Check the exact requirement in your licensed copy of the standard.
Put it into practice
Draft, approve and e-sign your SOPs with version control, or get the complete template pack.