ISO 15189:2022 · Section 5 · Structural and governance requirements
Clause 5.4: Structure and authority
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Laboratory structure should make responsibility and decision making clear across the whole service. Staff need to know who directs their work, who can authorise technical decisions and who can escalate an unresolved concern. These arrangements must also fit the laboratory's place within a larger organisation, where finance, human resources or information services may control important resources.
Use an organisation chart together with role descriptions and specific authorisations. A chart shows reporting relationships, but it rarely explains who can release results, suspend work, approve procedural changes or accept a corrective action. Document these boundaries and make them accessible to the people who need to act on them.
Quality responsibilities require particular clarity. Assign people sufficient authority, time and access to leadership to coordinate the management system, identify departures from procedures and support improvement. Quality is not transferred entirely to one coordinator: section leads and operational staff remain responsible for the work they perform. Effective arrangements connect technical expertise, operational decisions and independent review where needed.
Check how the structure functions during absences, night shifts, cross site working and major incidents. A deputy should know both the authority received and the limits of that authority. When roles change, review documents, system permissions and communication routes together. Evidence should show that staff can use the structure to resolve real problems, not just recognise their manager's name. Clear accountability reduces delays when competing priorities arise and helps ensure that patient related concerns reach someone who can take effective action.
What assessors typically ask to see
- How does the organisation chart show laboratory leadership and links to the wider legal organisation?
- Who is authorised to stop unsafe work, approve restart and arrange an alternative service?
- How are management system responsibilities assigned with adequate authority and access to senior leadership?
- How are deputies and cross site responsibilities communicated during evenings, weekends and planned absences?
- How are role descriptions and system permissions updated when a person changes responsibilities?
Documents and records that usually provide evidence
- Organisation chart with approval and revision history
- Role descriptions and responsibility allocation matrix
- Technical authorisation and delegated authority register
- Deputy and out of hours escalation SOP
- Management system responsibility appointment records
- Role change communication and access review forms
Common findings to avoid
- The organisation chart shows vacant or obsolete posts without identifying who currently holds their responsibilities.
- Quality staff are expected to resolve systemic problems but cannot access decision makers or necessary information.
- Different procedures assign conflicting authority for stopping and restarting a laboratory activity.
- Deputies are listed without evidence that they understand or are competent for the delegated decisions.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 5.4 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 5.4 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Is an organisation chart enough?
No. The chart provides an overview, while role descriptions, authorisation records and procedures explain specific decisions. Staff should be able to connect the two. Test the arrangement with an actual scenario, such as an unresolved control failure during a night shift, and check who can act.
Must every responsibility belong to a separate person?
Not necessarily. Smaller services may combine roles when competence, workload and potential conflicts are addressed. Make the combined responsibilities explicit and arrange alternative review where someone would otherwise approve their own disputed decision. A simple structure can be effective if its limits and safeguards are understood.
How can the laboratory check that authority is understood?
Use induction discussions, scenario exercises, audit interviews and review of actual escalations. Ask staff what they would do, whom they would contact and what happens if the first person is unavailable. Resolve inconsistencies between practice and documents rather than treating a signed role description as sufficient evidence.
Check the exact requirement in your licensed copy of the standard.
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