Our experience of implementing ISO 15189 (NABL Certification)

Our Experience of Implementing ISO 15189 (NABL Certification)

Implementing a quality management system in a medical laboratory is both challenging and rewarding. At LABASSURE, our journey towards achieving ISO 15189 accreditation (NABL Certification in India) gave us deep insights into the importance of quality, documentation, training, and audits.

For many labs, the goal of certification often drives the process. However, the real purpose should always be about improving quality and patient outcomes—not just compliance. Here, we share our experience of implementing ISO 15189, the international standard for medical laboratories.

Understanding ISO 15189: NABL Certification for Medical Labs

• ISO 15189 is the international quality standard specifically designed for medical laboratories.

• It ensures that labs meet rigorous requirements in competence, impartiality, and consistent performance.

• In India, accreditation is granted by NABL (National Accreditation Board for Testing and Calibration Laboratories).

Unlike general standards like ISO 9001, ISO 15189 is tailored to diagnostic labs, covering everything from human resource management and vendor performance to equipment calibration and reporting accuracy.

Challenges in Implementation

Implementing ISO 15189 can feel intimidating. Concerns about assessor expectations, documentation requirements, and training needs often cause apprehension.

We identified three key challenges:

1. Documentation overload – understanding what is necessary vs what is “for compliance.”

2. Training requirements – translating guidelines into daily lab practices.

3. Shifting focus – ensuring the team focuses on quality improvement, not just passing the audit.

Our Approach to ISO 15189 Implementation

Instead of hiring external consultants, we decided to build our system in-house, guided by three principles:

1. Relevance – Every document and process must serve a real purpose.

2. Utility – Documents should be working tools, not just files for audits.

3. Elegance & Access – Documents must be clear, neatly designed, and easily accessible (via printed forms and shared intranet folders).

We conducted two pre-audits (document-based and site-based) to identify gaps and make improvements before the final assessment.

Key Pillars of a Quality System

1. Documentation

• Provides consistency, traceability, and accountability.

• Every task is documented through policies, guidelines, and tracking sheets.

• Helps in identifying errors, timelines, and areas of improvement.

2. Training

• Essential for bridging the gap between standards and practice.

• Includes both technical training and quality-related training.

• Staff are trained on documentation, process compliance, and best practices.

3. Audit

• Ensures activities are performed as planned.

• Creates accountability among staff.

• Highlights training needs, process improvements, and documentation gaps.

• Should be seen as a tool for continuous improvement, not fault-finding.

Lessons Learned

• Quality is a journey, not a destination. Accreditation is only the starting point.

• The latest ISO 15189:2015 emphasizes continual improvement, using the PDCA cycle (Plan–Do–Check–Act).

• Internal collaboration and employee involvement are crucial—quality cannot be imposed top-down.

• The process highlighted opportunities for sustainability, efficiency, and better patient care.

Conclusion

Our experience with ISO 15189 and NABL accreditation showed us that while the certification process can be challenging, it transforms the laboratory culture. The focus shifts from compliance to quality improvement, fostering trust, reliability, and better outcomes for patients and clinicians.

At LABASSURE, we continue to evolve our quality management systems in line with ISO 15189 to ensure excellence in diagnostics.

📧 To know more about our NABL-accredited genetic testing services or ISO 15189 implementation insights, write to us at info@labassure.com

‍