NABL ISO 15189 Technical Compliance

Project Background

A high-throughput diagnostic laboratory located in Delhi NCR sought NABL (ISO 15189) accreditation to prove its technical competence, bid for corporate contracts, and establish absolute trust among its network of referring physicians.

The Challenge

The laboratory struggled with irregular equipment calibration schedules and missing Internal Quality Control (IQC) documentation. The technical staff lacked deep awareness regarding ISO 15189 requirements, leading to improper validation of daily testing protocols and occasional reporting errors.

Scope of Support

The Sasha Group’s technical consultants established a rigorous, customized Quality Manual. We corrected and standardized all calibration logs, enforced strict IQC participation, and trained the lab technicians heavily on identifying errors through formal Root Cause Analysis (RCA) and Corrective Actions.

Key Outcomes

Achieved official NABL Accreditation within the projected timeline.
Drastically reduced testing error rates through disciplined IQC practices.
Secured immense trust among physicians, directly increasing sample inflow.
Empowered technical staff to independently manage and sustain quality audits.

Implementation Timeline

Step 1

Assessment

Initial review of systems, documentation, infrastructure, and operational practices.

Step 2

Gap Analysis

Detailed comparison against applicable standards and regulatory requirements.

Step 3

Planning

Creation of implementation roadmap and department responsibilities.

Step 4

Implementation

Execution of documentation, workflow improvements, and compliance measures.

Step 5

Training

Department-level orientation and operational readiness support.

Step 6

Readiness Review

Mock assessments and final preparation before evaluation.

Systems Addressed

Biochemistry Clinical Pathology Calibration Systems Quality Control Sample Workflow Documentation

Related Expertise

Discover the structured methodology and operational depth behind this implementation.

View Service Details