Making sure that test results are accurate, reliable, and reproducible is fundamental to any laboratory’s quality management system. For pathology and clinical labs in India, obtaining NABL (National Accreditation Board for Testing and Calibration Laboratories) and ISO 15189 accreditation signifies a commitment to international standards and quality. A key part of this process is engaging in External Quality Assurance Schemes (EQAS).
Our EQAS, developed by Image Computer Systems with 27+ years of expertise, empowers laboratories to validate their test results against trusted benchmarks while streamlining compliance with global standards.
In this blog, we’ll explore the crucial role of laboratory quality management system in achieving NABL and ISO 15189 accreditation and why it is indispensable for modern laboratories.
What is NABL and Why Is It Important?
NABL, or the National Accreditation Board for Testing and Calibration Laboratories, is an independent organization under the Quality Council of India. It plays a crucial role in accrediting testing and calibration labs, and its accreditation is seen as a gold standard for technical expertise and compliance with international norms.
For labs, getting NABL certified means:
- Meeting the ISO 15189 accreditation standards.
- Boosting trust among clinicians, patients, and regulatory bodies.
- Enhancing quality control processes and minimizing the chances of errors.
Understanding ISO 15189 Accreditation
Understanding ISO 15189 Accreditation is all about ensuring quality and competence in medical laboratories. This standard highlights a few key points: – A strong laboratory quality management system is essential. – There’s a focus on continual improvement through regular internal audits and quality controls. – Labs should also engage in External Quality Assessment Schemes (EQAS) to assess their performance and accuracy.
As of January 2024, approximately 8,588 laboratories in India hold NABL accreditation, comprising 2,165 medical (ISO 15189compliant) laboratories, 5,127 testing laboratories, and 1,208 calibration laboratories, along with 70 proficiency testing providers and 18 reference material producers. Medical laboratories accredited to ISO 15189—including pathology and clinical labs—make up the core group required for NABL compliance on quality testing. While comprehensive data for 2025 is not yet publicly published, these figures represent the most recent verified snapshot of NABL accredited labs in India.
The role of laboratory quality management system in NABL and ISO 15189 Accreditation
EQAS serves as an external audit for a lab’s testing capabilities. By comparing results with those from peer laboratories and established reference standards, the laboratory quality management system helps ensure that a lab’s results are accurate, reliable, and consistent.
Here are some key contributions:
Performance Validation: EQAS helps identify any deviations or biases in testing, enabling labs to address these issues proactively.
Regulatory Compliance: Both NABL and ISO 15189 require proof of external quality checks, and participating in EQAS meets this requirement.
Continuous Improvement: Regular involvement in laboratory quality management system strengthens the laboratory’s quality management system by highlighting areas that need improvement.
Data-Driven Insights: Labs receive valuable insights that help them optimize equipment calibration, refine methodologies, and enhance staff training.
Key Features of a laboratory quality management system
Comprehensive Quality Checks
The EQAS platform is all about ensuring top-notch quality checks. It allows master labs to set up various laboratory quality management system cycles that cover a broad spectrum of tests. Each cycle can feature multiple analytes or test parameters, making it super versatile. This functionality guarantees that all essential examinations in participant labs are regularly validated. By conducting thorough comparisons, the system plays a crucial role in confirming the accuracy of laboratory instruments and methods throughout every stage of testing.
Real-Time Benchmarking
One of the standout features of laboratory quality management system is its ability to let labs compare their performance against a reference in real time. On our platform, master labs can enter reference results, which might come from a well-known reference laboratory or from aggregated peer values. The system quickly assesses each participant’s results against these references. This means labs can instantly see whether their results are within acceptable limits or if they’re outliers. Since the reference data is often sourced from top analyzer systems across different manufacturers, the benchmarking is solid – it provides participants with the assurance that they’re meeting industry standards, while also giving providers a comprehensive view of how all instruments are performing throughout the network.
Supports Unimodal and Multimodal Testing
Laboratories are equipped with a range of tools, and some laboratory quality management system programs might have all participants using the same model or method (which we call unimodal), while others might mix different brands and models (that’s the multimodal approach). The EQAS solution is designed to handle both situations. In unimodal mode, since everyone is using the same method, all results can be compared directly. On the other hand, in multimodal mode, the software organizes results by instrument or method, allowing for fair performance comparisons across different groups.
Robust & Low Maintenance
When it comes to implementing a quality system, one of the biggest worries is how much maintenance it will require. That’s where the laboratory quality management system platform excels—it has a solid reputation for running smoothly with minimal support. It’s built to be both reliable and stable, meaning that once you set up the programs and schedules, you won’t have to intervene much at all. This is super important for both providers and participants, as labs simply can’t afford any downtime in their quality programs. The system even offers automated reminders to let labs know when it’s time to submit their results, and it takes data security seriously, ensuring that confidentiality and integrity are always maintained.
Final Thoughts
Getting NABL and ISO 15189 accreditation isn’t just about ticking boxes for technical requirements: it’s really about building trust, ensuring patient safety, and showing a genuine commitment to quality through a solid laboratory quality management system. External Quality Assurance Schemes (EQAS) are essential in this process, providing objective validation of test accuracy and reliability while encouraging ongoing improvement.
Our laboratory quality management system, crafted by Image Computer Systems, is tailored to empower both master and participant laboratories with real-time benchmarking, automated reports, and flexible programs that make it easier to comply with NABL and ISO 15189 standards. By incorporating such a cutting-edge EQAS into your quality framework, you can confidently meet accreditation requirements and boost your laboratory’s reputation.
Are you ready to take your lab’s quality standards to the next level? Schedule a free EQAS demo today and see how we can help you achieve excellence and success in accreditation!