Key Steps to Achieve Medical Lab Accreditation in India

In today’s quality-driven healthcare ecosystem, achieving medical lab accreditation is essential for laboratories that want to ensure credibility, enhance diagnostic accuracy, and gain trust across India. Accreditation helps improve operational efficiency and aligns your laboratory with global best practices. FDASIndia, located in Gurgaon, India, guides diagnostic labs and medical device testing facilities through every step of the accreditation process.

This article outlines the critical steps to help your lab secure accreditation under globally recognized standards like ISO 15189 and other regulatory frameworks applicable to medical device testing lab accreditation in India.

Why Medical Lab Accreditation Matters?

Whether you’re a standalone diagnostic lab or part of a multi-facility healthcare chain, accreditation provides:

• International recognition and credibility
• Confidence in lab results and processes
• Enhanced patient and partner trust
• Compliance with national and global regulations

FDASIndia specializes in helping labs across the country attain these advantages through structured compliance and support.

Step 1: Understand the Right Accreditation Standard

The most recognized standards for labs in India include:

• ISO 15189 outlines quality and technical standards specifically for medical laboratories, ensuring reliable and competent lab services.
• ISO 17025 – For calibration and testing laboratories, including medical device testing
• FDAS India helps you determine the right standard based on your services, whether clinical diagnostics or medical device testing lab accreditation.

Step 2: Conduct a Gap Analysis

Before applying, it’s important to assess your lab’s current processes against the selected accreditation standards.

Key areas to evaluate:

• Personnel competence and training
• Equipment calibration and maintenance
• Sample management and reporting

Step 3: Implement a Quality Management System (QMS)

A robust QMS is the backbone of any accredited lab. This includes:

• Standard Operating Procedures (SOPs)
• Document control and record-keeping
• Risk management policies
• Continuous improvement practices

FDAS India offers tailored implementation support to develop your QMS from scratch or optimize your existing framework.

Step 4: Train Your Staff

Your team must be trained to comply with the chosen accreditation framework. FDAS conducts specialized training programs for:

• Lab Technicians
• Quality Managers
• Internal Auditors

We help your team grasp the essentials of ISO 15189, making audits more efficient and supporting sustained compliance.

Step 5: Internal Audit & Management Review

Conducting an internal audit before applying can uncover gaps and save time during the official audit. A management review meeting must also be held to evaluate the lab’s readiness.

FDAS provides audit checklists, conducts mock assessments, and ensures you’re ready for external evaluation.

Step 6: Submit Your Accreditation Application and Get Ready for Evaluation

Once your lab is compliant:

• Submit your application to NABL or relevant body
• Prepare documents and QMS records
• Coordinate for on-site assessments and corrective actions

FDAS acts as your accreditation partner from application to final approval.

Partner with FDAS India for Smooth Accreditation

FDAS India is your trusted partner for medical lab accreditation, ISO 15189 certification, and medical device testing lab accreditation. With deep regulatory expertise, nationwide experience, and hands-on support, we make the accreditation journey seamless and efficient.

Ready to get accredited?

Contact FDAS India today to begin your journey toward laboratory excellence and compliance.

📩 Visit: www.fdasindia.org

📞 Call: +91 8448278215

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