ISO Clauses
What ISO clause requires evaluating lab workspace for adequacy?
ISO15189:2022 Clause 6.3
What record must be kept for daily cleaning?
Housekeeping
What must sample collection areas provide to patients?
Privacy and accessibility
What does the safety program include?
Training, inspections, accident reporting, fire, first aid, waste management etc
How should hazardous waste be disposed of?
Contracting a medical waste company. Autoclaving/incineration, sharps in puncture-proof containers
Which ISO clause relates to lab ventilation and climate control?
ISO15190:2020 Clause 9.2
What must be done to surfaces after each shift?
disinfect or wipe
How should patient care and testing areas be arranged?
Clearly separated to avoid cross-contamination
How often must biosafety cabinets be certified?
Annually
How should waste containers be maintained?
Clearly labelled, not overfilled
What ISO clause requires biosafety cabinets to be certified annually?
ISO15190:2020 Clause 7.7
What should be clearly labeled to prevent contamination?
reagents/controls/stains/liquids reconstituted or made up.
What area must be kept clean and designated for paperwork?
Clerical work area, bench where there is no sample testing
What must the safety manual cover?
all aspects of the lab - safety aspects to ensure safety for both management and staff. Blood precautions, fire/electrical safety, waste
What symbol must appear on waste containers?
Biohazard symbol
Which clause ensures the lab has a documented safety procedure?
ISO15190:2020 Clause 12.10
What should NOT be stored with lab materials?
Food, drinks, personal items
Why are backup power systems essential?
To maintain testing during outages
Where should PPE and personal drinking water be stored?
In designated personal areas
What emergency equipment must be functional and tested?
Eye wash stations, fire alarms
What clause covers lab access control and security?
ISO15190:2020 Clause 4.3.3
What signage must be displayed in the lab?
Fire, first aid, exit signs, no eating, clean and dirty areas, fire blankets, extinguishers,
What facility supports safe testing environments?
Ventilation and climate control systems
What system ensures critical equipment runs during power loss?
Backup power (generators or UPS)
Why must cables and wires be secured?
To prevent electrical hazards