ISO 15189:2022 Consultancy
Consultancy Services for Medical Testing Laboratories
We provide end-to-end consultancy services for Medical Testing Laboratories, supporting laboratories in establishing, implementing, and maintaining quality systems in compliance with ISO 15189, ISO/IEC 17025 (where applicable), and NABL (Medical) accreditation requirements.
Our consultancy focuses on patient safety, technical competence, regulatory compliance, and audit readiness, ensuring laboratories meet national and international quality expectations.
Quality Management System (QMS) Implementation
- ISO 15189:2022 awareness and implementation support
- Quality manual preparation
- SOPs for pre-examination, examination, and post-examination processes
- Document and record control systems
NABL Medical Accreditation Support
- NABL application and scope finalization
- Gap analysis against NABL (M) requirements
- Preparation for pre-assessment and final assessment
- Closure of non-conformities
Technical & Operational Consultancy
- Test method verification and validation
- Equipment selection and qualification
- Calibration and maintenance planning
- Measurement uncertainty (where applicable)
- Reagent, consumable, and kit validation
Internal Audit & Management Review
- Internal audit planning and execution
- Clause-wise audit checklists
- Root cause analysis and corrective action
- Management review facilitation and reporting
Biosafety & Risk Management
- Laboratory biosafety practices
- Risk assessment and mitigation
- Sample handling and storage protocols
- Waste management and disposal procedures
Personnel Competency & Training
- Competency assessment programs
- Role-based training modules
- Continuing education planning
- Training records and evaluations
Quality Control & Assurance
- Internal Quality Control (IQC) planning
- External Quality Assessment (EQA/PT) participation guidance
- Result validation and reporting practices
- Turnaround time (TAT) monitoring
Data Integrity & Laboratory Information Systems
- Data integrity awareness (ALCOA+ principles)
- LIS selection and implementation guidance
- Result authorization and traceability
- Record retention policies
Medical Laboratory Disciplines Covered
- Clinical Biochemistry
- Haematology
- Microbiology
- Immunology & Serology
- Histopathology & Cytopathology
- Molecular Diagnostics (PCR)
- Blood Bank (as applicable)
Consultancy Deliverables
- ISO 15189-compliant documentation set
- NABL-ready formats and templates
- Risk registers and audit tools
- Validation and verification protocols
- Assessment preparation support
Why Choose Us
- Experience with NABL Medical laboratories
- Practical implementation approach
- Patient-centric quality focus
- Regulatory and ethical compliance
- Customized solutions for lab size and scope
Compliance & Ethical Statement
Our consultancy services are limited to system implementation and compliance support.
We do not perform accreditation, certification, testing, or medical diagnosis activities.
