Leading Laboratory Accreditation Body for Testing, Calibration, & Medical Labs

In the dynamic landscape of India's laboratory testing and calibration industry, FDAS India (Federation for Development of Accreditation Services) stands out as a premier laboratory accreditation body in India. Established in 2019, FDAS India offers internationally recognized accreditation services that help laboratories demonstrate technical competence, reliability, and compliance with global standards like ISO/IEC 17025 and ISO 15189.

What is FDAS India?

FDAS India is a non-governmental, non-profit organization registered under the Haryana Registration and Regulation of Societies Act. It was created to supplement the accreditation ecosystem in India to meet the growing demand for accreditation services from the country’s vast network of testing, calibration, and medical laboratories.

Unlike traditional accreditation bodies, FDAS operates with a mission to accelerate quality culture in laboratories by offering efficient, transparent, and internationally compliant accreditation programs. The organization manages its accreditation system entirely in line with ISO/IEC 17011 standards, which specify requirements for accreditation bodies.

International Recognition and Memberships

FDAS India holds full membership and signatory status to key international arrangements, providing its accredited laboratories with global market acceptance:

• ILAC Mutual Recognition Arrangement (ILAC MRA) signatory since August 28, 2023
  
  

• Asia Pacific Accreditation Cooperation (APAC MRA) signatory since June 16, 2023
  
  

These international credentials ensure that test and calibration results from FDAS-accredited laboratories are recognized worldwide. This global recognition is critical for India’s laboratories seeking international trade opportunities and technical equivalence.

Accreditation Services Offered by FDAS India

Testing Laboratories Accreditation (ISO/IEC 17025)

FDAS India accredits testing laboratories across disciplines such as chemical, biological, mechanical, environmental, and industrial sectors. This accreditation confirms that laboratories comply with ISO/IEC 17025 standards, highlighting technical competence and ensuring the validity and reliability of test results.

Calibration Laboratories Accreditation

Calibration labs that provide measurement services can achieve accreditation under ISO/IEC 17025 through FDAS India. This accreditation ensures that their measurements and calibration results meet international traceability and precision standards, essential for quality manufacturing and research.

Medical Laboratories Accreditation (ISO 15189)

FDAS also extends its accreditation services to medical and clinical laboratories adhering to ISO 15189:2022 standards. Accreditation here assures that labs maintain exceptional quality management systems and technical expertise critical for diagnostic accuracy and patient safety.

Why Choose FDAS India for Accreditation?

Rapid and Transparent Process

FDAS India offers a streamlined accreditation process with electronic application submissions to reduce delays. This innovative approach helps speed up the assessment timeline while maintaining rigor and transparency.

Compliance with International Norms

FDAS commits to abiding strictly by the norms of international bodies such as ISO, IEC, ILAC, and APAC, providing accredited laboratories with full global equivalency and acceptance. This seamless international alignment distinguishes FDAS from other accreditation agencies.

Supporting India’s Ambitious Growth

India has about six lakh laboratories, comprising roughly three lakh testing laboratories and three lakh medical laboratories. Given the country's target to become a five trillion-dollar economy, the need for an accreditation body like FDAS is crucial to match the scale by enabling quality assurance and accreditation proliferation throughout the vast laboratory network.

Focus on Quality Culture Development

FDAS pushes for a culture of continual improvement and quality excellence within laboratories. Through guidance, training, and consultation services, FDAS helps labs integrate best practices and elevate their technical competencies for sustainable growth.

The Accreditation Process with FDAS India

The accreditation journey with FDAS includes:

1. Application Submission: Laboratories submit a detailed application digitally via FDAS’s official channel.
   
   

2. Document and System Review: FDAS experts evaluate quality manuals, procedures, and management systems for compliance.
   
   

3. On-site Assessment: Technical assessors conduct thorough evaluations of laboratory infrastructure, procedures, and personnel competence.
   
   

4. Action on Non-Conformities: Laboratories address any discrepancies pointed out during assessments.
   
   

5. Grant of Accreditation: Upon meeting requirements, FDAS issues an accreditation certificate, valid for a specified period with surveillance audits.
   
   

FDAS also supports laboratories with ongoing compliance through periodic assessments and refresher training workshops.

Advantages of FDAS Accreditation

• Global Recognition: FDAS accreditation opens doors for laboratories to gain international confidence and acceptance.
  
  

• Enhanced Credibility: Accreditation demonstrates technical competency, improving client trust and business opportunities.
  
  

• Market Competitiveness: Accredited laboratories can participate effectively in national and international tenders and collaborations.
  
  

• Quality Assurance: Helps laboratories maintain state-of-the-art quality management and technical accuracy.
  
  

• Operational Efficiency: Accreditation drives process improvements, reduces errors, and promotes continuous quality enhancements.
  
  

Conclusion

FDAS India provides an essential, internationally aligned accreditation service within the rapidly expanding Indian laboratory framework. With the backing of ILAC and APAC MRAs, FDAS helps testing, calibration, and medical laboratories achieve verified competence and global acceptance under ISO/IEC 17025 and ISO 15189 standards.

For laboratories aspiring to raise their quality and technical standards to international levels while supporting India’s economic growth ambition, FDAS India offers the most trusted and recognized accreditation pathway.

What is the accreditation body for iso iec 17025 in India

The primary accreditation body for ISO IEC 17025 in India, aside from government authorities, is FDAS India (Federation for Development of Accreditation Services). FDAS India provides ISO/IEC 17025 accreditation services to testing and calibration laboratories, enabling them to demonstrate technical competence and international recognition within India and globally.

Understanding ISO/IEC 17025

ISO IEC 17025 is an international standard for the competence of testing and calibration laboratories, emphasizing technical ability and the reliability of results. Laboratories that achieve ISO/IEC 17025 Accreditation in India demonstrate that they have implemented a quality system and are technically competent to produce valid and reliable results.

ISO IEC 17025 Accreditation Bodies in India

Among various agencies, FDAS India stands out as a non-government, legal entity established to grant ISO/IEC 17025 and ISO 15189 Accreditation to laboratories in India. FDAS operates its accreditation system to comply with ISO/IEC 17011 and is a signatory to international agreements such as the ILAC Mutual Recognition Arrangement (MRA) and the APAC Mutual Recognition Arrangement. This ensures that laboratories accredited by FDAS have global equivalence for their testing and calibration results.

FDAS India accepts applications for ISO/IEC 17025 Accreditation and provides guidance, assessment, and certification to ensure that accredited laboratories meet international standards for competence, impartiality, and performance.

The Accreditation Process with FDAS India

Accrediting a laboratory to ISO/IEC 17025 involves several key steps:

• Completing a detailed application and submitting the required documentation.
  

• Undergoing a technical assessment, which evaluates staff competence, methods, equipment, and recordkeeping.
  

• Implementing quality and management system requirements as per ISO/IEC 17025.
  

• Addressing non-conformities and continuous improvement based on feedback and audits.
  
  

FDAS ensures compliance with norms from international institutions such as ISO, IEC, ILAC, and APAC, so accredited laboratories gain widespread acceptance in India and abroad.

ISO/IEC 17025 vs. ISO 15189 Accreditation

While ISO/IEC 17025 Accreditation relates to general competence in testing and calibration, ISO 15189 Accreditation is specific to medical laboratories. FDAS India offers both types of accreditations, supporting a wide range of laboratory functions.

Why Choose ISO/IEC 17025 Accreditation from FDAS India?

Laboratory accreditation agency recognition from the FDAS India provides several benefits:

• Enhances laboratory credibility and technical competence.
  

• Improves market access and customer trust for lab results that meet global benchmarks.
  

• Streamlines compliance with both domestic and international regulations and tender requirements.
  

• Fosters continuous improvement in quality systems and operational performance.
  
  

Benefits of ISO/IEC 17025 Certification

• Competence Assurance: Laboratories must demonstrate validated methods, skilled personnel, and reliable equipment.
  

• Impartiality: Ensures that laboratory decisions are unbiased and transparent.
  

• Global Acceptance: Accreditation by an internationally recognized body, such as FDAS opens opportunities for international business and collaboration.
  

• Continuous Improvement: Accredited laboratories regularly review and update processes for ongoing excellence.
  
  

The Role of FDAS India in Laboratory Accreditation

FDAS India has emerged as a trusted partner for organizations seeking reliable ISO/IEC 17025 Accreditation in India. With its internationally aligned procedures and commitment to quality, FDAS ensures that laboratories are equipped for long-term success. Services include:

• Consulting and training on ISO/IEC 17025 and ISO 15189 standards.
  

• Full guidance through the application, documentation, and assessment processes.
  

• Support in post-accreditation compliance and continual improvement.
  
  

Conclusion

In India, FDAS India provides a reliable, internationally recognized pathway for laboratories pursuing ISO/IEC 17025 Accreditation. This accreditation enhances technical credibility, supports market growth, and aligns laboratory operations with the highest standards in quality and performance. The support from organizations like FDAS India ensures that labs can confidently meet client, regulatory, and international expectations while maintaining operational excellence and technical validity.

Achieving ISO/IEC 17025 Accreditation: Key Steps and Benefits

In today’s competitive market, laboratories must demonstrate technical competence, reliability, and adherence to internationally recognized standards. ISO/IEC 17025 accreditation is widely recognized as a leading standard of quality for laboratory testing and calibration. This certification validates a laboratory’s ability to produce precise and accurate test and calibration results, assuring clients and regulatory bodies of its credibility.

For laboratories aspiring to enhance their reputation and operational efficiency, understanding the key steps to achieving ISO/IEC 17025 accreditation in India and recognizing its benefits is paramount.
You can also read:-Top Providers of ISO/IEC 17025 Accreditation in India?

Key Steps to Achieve ISO/IEC 17025 Accreditation

1. Understanding the ISO/IEC 17025 Standard

The journey starts with a thorough understanding of the ISO/IEC 17025 standard. Laboratories must familiarize themselves with the latest revision of the standard, which outlines criteria for competence in testing and calibration. This includes quality management system requirements and technical requirements such as method validation, equipment calibration, personnel competence, and traceability.

1. Conducting a Gap Analysi

A critical step is performing a gap analysis to compare the laboratory’s current management system and operations with the ISO/IEC 17025 requirements. This helps identify areas needing improvement or new controls to align with the standard.

1. Planning and Training

After identifying gaps, laboratories should design an implementation plan to address deficiencies. Training all personnel involved in testing, calibration, and management on the principles and requirements of ISO/IEC 17025 is essential to create awareness and build competence.

1. Documenting Policies and Procedures

Documenting a robust quality management system is fundamental. This includes writing policies, procedures, and instructions that govern laboratory operations, technical methods, equipment calibration, and record keeping. Proper documentation ensures consistency and accountability in all testing activities.

1. Implementing the Quality Management System

With documentation in place, laboratories must implement the system rigorously. This means following the established procedures and maintaining records demonstrating adherence to the defined processes.

1. Conducting Internal Audits

Internal audits assess the effectiveness and compliance of the laboratory’s quality system against ISO/IEC 17025. These audits help uncover nonconformities and areas for improvement before the external accreditation assessment.

1. Undergoing External Assessment

The accreditation body conducts an external assessment involving document review and a comprehensive on-site audit. Assessors evaluate the laboratory’s compliance with the standard, technical competence, and real-time adherence to procedures.

1. Addressing Nonconformities and Obtaining Accreditation

Any findings are addressed through corrective actions. Once the laboratory satisfactorily meets the requirements, the accreditation body issues the ISO/IEC 17025 accreditation certificate.

1. Maintaining Compliance and Surveillance

ISO/IEC 17025 accreditation mandates ongoing compliance and continuous improvement. Laboratories undergo periodic surveillance audits to ensure sustained adherence and to implement improvements.

Benefits of ISO/IEC 17025 Accreditation

• Enhanced Credibility and Recognition
  ISO/IEC 17025 accreditation is an international benchmark validating that a laboratory operates competently and generates valid results. This certification elevates the laboratory’s image both nationally and globally, fostering greater trust among clients, regulatory authorities, and stakeholders.
• Competitive Advantage
  Accredited laboratories gain a significant edge over non-accredited ones by meeting industry best practices. Many industries and government tender processes mandate ISO/IEC 17025 certification as a prerequisite, opening doors to lucrative business opportunities.
• Improved Operational Efficiency and Cost Reduction
  Implementing ISO/IEC 17025 brings systematic control over laboratory activities, reducing errors, retesting, and waste. The framework promotes effective resource management, which lowers operational costs while improving the quality of outputs.
• Consistent and Reliable Test Results
  The standard emphasizes method validation, equipment calibration, and competent personnel, ensuring consistent, accurate, and trustworthy test results. This reliability is crucial for client satisfaction and regulatory compliance.
• Facilitates Collaboration and Mutual Recognition
  ISO/IEC 17025 accreditation facilitates acceptance of test results across different countries, simplifying cross-border trade and cooperation between laboratories and industries worldwide.
• Boosts Employee Morale and Competence
  The accreditation process involves training and clearly defined roles, enhancing staff skills, engagement, and accountability which contribute to overall laboratory success.

ISO/IEC 17025 Accreditation in India

In India, laboratories seeking to demonstrate their technical competence and quality assurance pursue ISO/IEC 17025 accreditation primarily through NABL. This accreditation ensures that testing and calibration laboratories meet international standards, thereby gaining national and global acceptance. The process is rigorous but rewarding, strengthening the laboratory’s position in the market.

Partner with the Right Laboratory Accreditation Body

Choosing the right laboratory accreditation body is vital to ensure a smooth accreditation process and ongoing support. FDASIndia is a leading ISO/IEC 17025 accreditation body that specializes in guiding laboratories throughout their journey to certification in India.

FDASIndia helps laboratories efficiently achieve and uphold ISO/IEC 17025 accreditation through expert guidance, personalized consultancy, and unwavering quality standards.

By adhering to internationally recognized standards and embracing continuous improvement, laboratories endorsed by FDASIndia can confidently deliver excellence, build trust, and unlock new growth opportunities in their respective industries.
Achieve ISO/IEC 17025 accreditation and elevate your laboratory’s credibility and operational excellence by partnering with FDASIndia — your trusted guide to quality and compliance.

APAC MRA role in global standards and certifications

 The Asia Pacific Accreditation Cooperation (APAC) plays a pivotal role in shaping global standards and certifications through its Mutual Recognition Arrangement (MRA), which facilitates the acceptance and harmonization of conformity assessment results across the Asia Pacific region and beyond. Understanding the significance of APAC MRA is essential for industries, especially those in the medical and testing fields, to leverage international trust, reduce trade barriers, and achieve seamless market access.

The Role of APAC in Global Standards and Certifications

APAC was established in 2019 by merging two prominent regional organizations—the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Pacific Accreditation Cooperation (PAC). This consolidation strengthened regional cooperation in accreditation by streamlining processes and expanding the reach of mutual recognition.

APAC’s mission is to strengthen the Mutual Recognition Arrangement (MRA) among Asia Pacific accreditation bodies. 

The MRA is a binding agreement that ensures conformity assessment results—such as test reports, certificates, and inspection outcomes—issued by a conformity assessment body (CAB) accredited by one APAC MRA signatory are accepted by all other signatories.

 

This creates a unified accreditation environment, enabling "tested/inspected/certified once, accepted everywhere," reducing duplications, saving costs, and accelerating international trade.

APAC is recognized by global organizations like the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), which extends the mutual recognition of accredited results beyond the Asia Pacific, connecting it to a global network. This global alignment is crucial for industries relying on stringent quality assurances, such as medical devices, calibration, and testing laboratories.

How APAC MRA Benefits Medical Device Testing Lab Accreditation

In the realm of medical devices, where safety and compliance are non-negotiable, APAC MRA’s role is particularly impactful. 

Accreditation under the APAC MRA umbrella certifies that medical device testing laboratories meet international standards such as ISO/IEC 17025 and ISO 15189, which cover laboratory competence and quality management. 

These accreditations ensure that test results are reliable and accepted internationally, removing the need for retesting the same devices in multiple countries.

This is especially significant for regulatory compliance in the highly regulated medical device market, where laboratories accredited under APAC MRA signatories provide reports that authorities worldwide recognize. 

The APAC MRA helps medical device manufacturers accelerate product registration and market entry by offering internationally trusted certifications. 

Laboratories with APAC MRA accreditation are equipped with state-of-the-art equipment, qualified personnel, and validated testing methods, underpinning safety and quality in medical device development and evaluation.

Moreover, the APAC MRA framework supports the accreditation of a diverse range of conformity assessment bodies, including those involved in inspection and certification beyond testing, further broadening its influence in global standards.

The Importance of Testing Lab Accreditation Within APAC

Testing lab accreditation is a fundamental pillar that ensures consistent quality and competence across industries. APAC’s role in harmonizing testing lab accreditation practices means laboratories are held to international benchmarks. 

Accredited labs assessed under APAC guidelines exhibit technical competence and impartiality, which are crucial in providing trustworthy results that regulatory bodies and consumers can rely on.

The APAC MRA’s mutual recognition streamlines cross-border trade by eliminating unnecessary testing and certifications, enabling faster, smoother, and more cost-effective transactions. For laboratories aspiring to serve the global market, APAC MRA signatory status is a mark of quality and global acceptance.

FDASIndia’s Role in APAC MRA and Accreditation Services

FDASIndia is a proud full member and signatory of the APAC MRA for testing and calibration. As a leading accreditation body in India, FDASIndia aligns its accreditation programs with international standards such as ISO/IEC 17025:2017 for testing laboratories and ISO 15189:2022 for medical laboratories. 

This commitment ensures that CABs accredited by FDASIndia meet the highest levels of competence recognized regionally and globally, providing clients with internationally accepted conformity assessment results.

FDASIndia’s accreditation services empower laboratories to achieve APAC MRA status, thereby enhancing their credibility and facilitating wider market access. 

By supporting medical device testing lab accreditation and general testing lab accreditation under the APAC framework, FDASIndia plays a vital role in boosting trust, quality, and economic efficiency in the Asia Pacific and beyond.

For medical device manufacturers and laboratories seeking to leverage the efficiencies of the APAC MRA and attain robust accreditation, partnering with FDASIndia is a strategic step towards global compliance and business growth. 

FDASIndia’s expertise in navigating accreditation requirements ensures that your laboratory is equipped to meet global standards, driving innovation and facilitating international trade.

By understanding and embracing the APAC MRA’s role in global standards and certifications, and with trusted partners like FDASIndia providing top-tier medical device testing lab accreditation and testing lab accreditation services, businesses can achieve recognized quality assurance essential for international success.

For more information, visit FDASIndia’s official website to explore accreditation services and how your organization can benefit from APAC MRA membership and recognition.