ISO 15189 Implementation
ISO 15189 is an internationally recognized standard specifically designed for medical laboratories. It ensures quality, competence, and reliability in testing patient samples, covering both management and technical requirements.
At Scientific Seva NABL Consultants, we provide complete support for ISO 15189 implementation, helping medical laboratories achieve NABL accreditation with structured processes, documentation, and training.
Scope of ISO 15189
- Clinical Biochemistry
- Pathology & Histopathology
- Haematology
- Microbiology
- Molecular Diagnostics
- Genetic Testing
- Immunology & Serology
Our ISO 15189 Implementation Services
- Gap Analysis of Existing Laboratory System
- Quality Manual & SOP Preparation
- Documentation & Record Management
- Training for Lab Personnel
- Internal Audit & Management Review
- Pre-Assessment & NABL Audit Preparation
- Final Accreditation Support
Key Requirements of ISO 15189
- Patient Safety & Confidentiality
- Sample Collection & Handling Procedures
- Equipment Calibration & Maintenance
- Quality Control & Assurance
- Competency of Laboratory Staff
- Accurate Reporting & Documentation
Benefits of ISO 15189 Accreditation
- Improved accuracy and reliability of test results
- Increased patient trust and confidence
- Compliance with NABL and regulatory requirements
- Enhanced laboratory efficiency and quality systems
- Recognition at national and international level
Implementation Process
- Initial Consultation & Planning
- Gap Analysis
- Documentation Preparation
- Training & Implementation
- Internal Audit
- NABL Application Submission
- Pre-Assessment
- Final Assessment & Accreditation