Key Elements of ISO 15189:2022 in a Medical Laboratory
ISO 15189:2022 specifies requirements for quality and competence in medical laboratories, providing a robust framework to establish effective quality management systems, demonstrate technical competence, ensure reliable testing, and support patient-focused services.
At Chem-Labs, we believe quality goes beyond supplying medical laboratory equipment. As an ISO certified laboratory equipment supplier in Kenya, we champion quality by supporting laboratories with reliable equipment, consistent performance, preventive maintenance (PPM), calibration & service traceability, 24/7 technical support, and operational continuity.
10 Key Elements of ISO 15189:2022 & How Chem-Labs Champions Quality
Explore how each key element of ISO 15189:2022 applies to medical laboratory quality management systems, and see the practical technical support solutions Chem-Labs provides to uphold them.
Quality Management System (QMS)
Standard Framework & Process ControlsEstablishes clear processes for laboratory operations, defines responsibilities, maintains controlled documentation, and integrates quality objectives into daily testing workflows.
How Chem-Labs Champions Quality:
- • Structured equipment maintenance programmes
- • Documented service activities & equipment histories
- • Preventive Planned Maintenance (PPM) execution
- • Digital tracking of field-service activities & lifecycle support
Competence of Laboratory Personnel
Qualified & Authorized Technical StaffEnsures personnel performing laboratory activities are qualified, trained, competent, authorized, and provided with ongoing professional development and evidence of competency.
How Chem-Labs Supports Personnel Competence:
- • Equipment installation & hands-on user training
- • Application specialist support & technical guidance
- • Training on proper equipment operation & maintenance
- • Support for laboratories adopting new technologies
Equipment and Infrastructure
Suitable, Installed & Serviced DevicesLaboratory equipment must be suitable for intended purpose, properly installed, maintained, monitored, and supported throughout its operational lifecycle to safeguard test result reliability.
How Chem-Labs Champions Equipment Quality:
- • Professional equipment installation & commissioning
- • Preventive Planned Maintenance (PPM) & servicing
- • Corrective maintenance & rapid fault resolution
- • Calibration support & service history traceability
Calibration and Measurement Reliability
Traceable Measurements & ConfidenceRequires measurement equipment to be controlled, with documented calibration and verification activities that maintain confidence in diagnostic accuracy.
Chem-Labs Approach:
- • Scheduled calibration support & verification
- • Preventive maintenance programmes & documentation
- • Digital field-service records & history tracking
- • Identification & follow-up of equipment requiring attention
Preventive Maintenance (PPM)
Proactive Equipment ManagementShifts laboratories from reactive repairs to proactive equipment management—reducing downtime, identifying faults early, extending service life, and supporting consistent workflows.
Chem-Labs PPM Approach:
- • Planned Preventive Maintenance (PPM) fixed schedules
- • Routine equipment inspections & preventive servicing
- • Identification of recurring equipment issues
- • Maintenance history tracking & service follow-up
Risk Management
Proactive Failure PreventionLaboratories must identify and manage risks affecting patient care, result accuracy, equipment performance, staff safety, and service continuity before problems turn into significant failures.
How Chem-Labs Contributes:
- • Preventive rather than purely reactive maintenance
- • Equipment condition monitoring & planned servicing
- • Rapid response to equipment faults & service escalation
- • Digital visibility of field-service activities
Documentation and Traceability
Automated Field Service TrackingDemonstrates what was done, when, and by whom—maintaining records for equipment, maintenance, calibration, service activities, CAPA, and training to support accountability.
Chem-Labs Digital Field Service Tracking App:
- • Digitizes field-service activities & tracks requests
- • Provides visibility of technician activities & response times
- • Records complete equipment service histories
- • Improves communication & supports service traceability
Reliable Technical Support
24/7 Rapid Emergency ResponseEquipment problems interrupt critical laboratory workflows. Technical support must provide timely response, qualified assistance, troubleshooting, escalation, and follow-up until resolution.
Chem-Labs 24/7 Technical Support:
- • 24/7 technical support for critical equipment needs
- • Rapid troubleshooting & technical assistance
- • Structured service escalation where required
- • Continued support beyond installation & commissioning
Continual Improvement
Everyday Quality CultureQuality management is an ongoing commitment. Laboratories must continually monitor performance, identify problems, analyze root causes, implement corrective actions, and evaluate effectiveness.
Chem-Labs Quality Philosophy:
"We don't just supply laboratory equipment. We support the systems, people and processes that keep laboratories performing reliably."
- • Preventive maintenance & digital service management
- • Technical expertise & equipment lifecycle support
- • Continuous customer support & data-driven service tracking
Patient-Centred Quality
Patient Safety & Diagnostic ConfidenceMedical laboratory quality ultimately contributes to patient safety and confidence in laboratory results. Reliable equipment supports accurate testing, consistent workflows, reduced downtime, timely results, and better continuity of healthcare services.
Chem-Labs Commitment:
"Quality is not simply about the equipment we supply. It is about helping laboratories maintain the reliability, performance and continuity required to deliver quality healthcare."
Why Choose Chem-Labs as Your Quality Partner?
We champion medical laboratory quality across Kenya and East Africa through six core operational pillars:
Preventive Planned Maintenance (PPM)
- Proactive equipment maintenance
- Reduced unexpected downtime
- Planned servicing schedules
Automated Field Service Tracking
- Digital service requests
- Equipment service history
- Technician activity & SLA tracking
Calibration & Equipment Servicing
- Supports measurement confidence
- Traceable calibration standards
- Documented maintenance activities
Expert Technical Support
- Qualified technical assistance
- Equipment troubleshooting
- Application specialist support
24/7 Technical Support
- Assistance for critical equipment issues
- Faster response & emergency dispatch
- Service escalation when required
Continuous Improvement
- Monitoring service performance
- Identifying recurring issues
- Improving equipment support processes
Frequently Asked Questions on Medical Laboratory Quality & Maintenance
Get expert answers on ISO 15189:2022 medical laboratory quality management, equipment maintenance schedules, and technical support.
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