ISO 15189:2022 · Section 5 · Structural and governance requirements
Clause 5.5: Objectives and policies
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What this clause is about
Policies describe the laboratory's intended direction, while objectives turn that direction into practical priorities. Both should reflect the needs of patients and users, the nature of the service and the laboratory's responsibility for dependable results. A policy is useful when staff can connect its commitments to decisions about work, resources and improvement.
Choose objectives that address meaningful service outcomes or process weaknesses. Examples might concern specimen acceptance, urgent result communication, competence reassessment or completion of agreed corrective actions. Define the population, calculation method, data source, review interval and responsible person so that different reviewers interpret progress consistently. Where a numerical target is unsuitable, define an observable completion or effectiveness criterion instead.
Objectives need resources and ownership. Before approving a target, consider whether staffing, equipment, information access and cooperation from other services are available. Avoid targets that reward speed while discouraging appropriate checks or incident reporting. Review unintended consequences alongside the intended benefit, especially where performance measures influence individual behaviour.
Communicate policies and objectives in language relevant to each team. Staff should know what they contribute and how difficulties are escalated. During review, compare performance with the agreed criteria, investigate important deviations and decide whether to adjust actions, resources or the objective itself. Record why changes were made. A completed action is not necessarily a successful outcome: checking whether the underlying problem improved is essential. The result should be a manageable set of priorities that supports clinical service quality rather than a growing collection of disconnected indicators.
What assessors typically ask to see
- How do current objectives address patient needs, user feedback and the laboratory’s significant service risks?
- For each objective, who owns the work and what evidence defines successful progress or completion?
- How are measures calculated consistently, including exclusions, data sources and the period being assessed?
- How are teams informed about the objectives relevant to their responsibilities and available resources?
- What decisions follow missed targets, unintended effects or evidence that an objective is no longer useful?
Documents and records that usually provide evidence
- Approved laboratory quality policy and review records
- Quality objectives register with owners and measures
- Indicator definitions and data collection SOP
- Objective action plans and resource approval forms
- Staff policy communication and briefing records
- Performance review minutes and effectiveness evaluations
Ready-made forms mapped to clause 5.5: Quality Objectives Form, Management Calendar.
Common findings to avoid
- Objectives use vague terms such as improve quality without a defined outcome or review method.
- Targets are reported repeatedly as missed without investigation, action ownership or a management decision.
- Data definitions change between reporting periods, making apparent improvement impossible to interpret reliably.
- Staff can find the policy but cannot explain how its commitments affect their daily work.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 5.5 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 5.5 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Must every objective use a percentage?
No. A time bound implementation objective may use defined milestones and a clear effectiveness check. When a percentage is appropriate, define both numerator and denominator. The important point is that progress can be evaluated consistently and that the chosen measure relates to a meaningful service need.
What if an objective is repeatedly missed?
Review the causes rather than automatically lowering the target. Check data quality, workload, resources and whether the planned actions address the actual problem. Escalate unresolved constraints and record any justified revision. Consider immediate patient protection if the missed objective indicates a significant safety concern.
How are policies kept relevant?
Review them against service changes, complaints, incidents, risk reviews and management decisions. Confirm that commitments remain appropriate and that staff have the means to implement them. Update linked objectives and procedures where necessary, and communicate substantive changes rather than relying only on publication of a revised document.
Check the exact requirement in your licensed copy of the standard.
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