ISO 15189:2022 · Section 6 · Resource requirements
Clause 6.4: Equipment
Check the exact requirement in your licensed copy of the standard.
Last reviewed
What this clause is about
Equipment management covers the full working life of devices that can influence laboratory activities, from selection and acceptance to maintenance, repair and retirement. This includes more than large analysers. Pipettes, centrifuges, refrigerators, thermometers and other supporting devices may affect sample integrity or examination performance and need proportionate control.
Before acquisition, define the intended use and the performance or operating requirements. Confirm that the location, utilities, staff skills and support arrangements are suitable. On receipt or installation, identify the device uniquely and complete appropriate acceptance checks before routine use. Manufacturer installation records can support acceptance, but the laboratory must establish that the equipment is suitable for its own intended work.
Keep instructions available and restrict operation to personnel with the necessary competence and authorisation. Plan maintenance and checks according to use, performance, supplier advice and risk. Records should allow a reviewer to connect a particular device with its location, maintenance history, faults, repairs and return to service decisions. Devices moved between areas need clear identification and reassessment where movement could affect performance.
When a fault occurs, prevent unintended use and assess work performed since the last satisfactory evidence of performance. Repair does not automatically establish readiness: define checks needed before return to service and consider calibration or method verification where relevant. Manage loaned and externally maintained equipment with the same attention to suitability. At retirement, protect retained information and remove inappropriate access or use. The aim is a traceable history showing that equipment remained fit for purpose throughout its authorised service.
What assessors typically ask to see
- How is equipment selected and accepted against the laboratory’s intended use before routine operation?
- How can staff identify a device’s current status, location and restrictions without relying on personal memory?
- How are maintenance schedules justified and overdue activities addressed before reliability is compromised?
- What checks are required after repair, relocation or extended shutdown before return to service?
- How are faults investigated for possible effects on examinations completed since the last satisfactory check?
Documents and records that usually provide evidence
- Equipment selection and acceptance SOP
- Equipment inventory and individual device history records
- Installation and acceptance check forms
- Preventive maintenance schedules and service logs
- Equipment fault and out of service labels register
- Repair and return to service authorisation records
- Equipment retirement and data disposal records
Ready-made forms mapped to clause 6.4: Incubator Temperature Monitoring Log, Water Bath Temperature Monitoring Log, Equipment Inventory List, Equipment Operating List, Equipment Decontamination Form, Equipment Maintenance & Occurrence Log.
Common findings to avoid
- Devices enter routine use after delivery without documented checks against the intended laboratory application.
- Maintenance records identify a device type but not the specific asset, date or work completed.
- Faulty equipment is labelled informally and can still be selected by staff working another shift.
- Repair closure records omit performance checks and assessment of results produced before the fault was detected.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 6.4 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 6.4 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Does all supporting equipment need an individual record?
Equipment that can influence laboratory activities needs identification and records sufficient for its control. The level of detail should match its role and risk. A critical pipette or storage unit should not disappear within a general purchasing list that cannot show its maintenance, checks or suitability.
Can a service engineer authorise return to routine use?
An engineer’s report is important evidence, but the laboratory must confirm that the equipment meets its own operational needs after the intervention. Define who can authorise return and what checks are required. Technical repair, calibration and examination performance checks may address different questions and should not be confused.
What if maintenance is delayed?
Assess the device’s condition, use, history and consequences of failure before deciding whether operation can continue. Record interim controls, the responsible decision maker and a firm plan. Do not simply change the due date to hide the delay, and suspend use where dependable performance cannot be supported.
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.