ISO 15189 – Medical Laboratories
About the Service
ISO 15189 is an internationally recognized standard specifically designed for medical laboratories. It establishes requirements for quality and competence, ensuring accurate, reliable, and timely laboratory results while enhancing patient safety, regulatory compliance, and overall laboratory performance.
Service Details
Medical Laboratory Quality Management System Implementation
Gap Analysis and Compliance Assessment
Quality Policy and Objective Development
Laboratory Process Standardization and Improvement
Method Validation and Quality Control Support
Equipment Calibration and Maintenance Management
Laboratory Documentation and Record Preparation
Risk Management and Regulatory Compliance Evaluation
Staff Competency Assessment and Training
Internal Audit Planning and Execution
Accreditation Audit Preparation and Coordination
Continual Improvement and Compliance Support
Add-Ons
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Key Performance Indicators (KPIs)
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