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Laboratory Improvement Ongoing

Strategic Accreditation Pathway: ISO/IEC 17025 QMS Implementation at Fishtech Laboratory

Client: Fishtech (BD) Limited

Project Overview

Fishtech Laboratory, a wing of Fishtech (BD) Limited, stands as a pioneer in Bangladesh’s aquaculture sector. Established with a vision to modernize the industry, Fish Tech BD Laboratory is the nation’s first private real-time PCR-based molecular laboratory dedicated to the health and sustainability of fish and shrimp farming. Fishtech laboratory serves as a critical technical hub and quality assurance facility for the aquaculture industry (farmers and hatcheries), providing data-driven insights that mitigate risks and maximize productivity.  

As international trade requirements increasingly demand accredited testing facilities to certify product safety, securing ISO/IEC 17025:2017 accreditation is a fundamental requirement for market access and technical credibility. TRACE Consulting will provide comprehensive handholding support to establish and implement an internationally recognized quality management system for the laboratory. This planned project will cover documentation, implementation, hands-on awareness training, proficiency testing (PT) sourcing, and internal audit preparation. The overarching goal is to establish Fishtech Laboratory as a recognized accredited facility, enabling its participation in global aquaculture trade markets and supporting national disease surveillance programs.

Project Details

Scope of Services: 

  • Gap Assessment: Conduct an in-person visit to the Khulna laboratory to perform a capacity assessment and comprehensive gap analysis across all matrix areas and facility infrastructure.  
  • Documentation Development: Develop a comprehensive quality manual, quality policy, technical SOPs, and required forms aligned with ISO/IEC 17025:2017 requirements.  
  • Implementation & Training: Deliver hands-on awareness training on ISO/IEC 17025 fundamentals, risk assessment methodologies, method validation, and measurement uncertainty calculation for all approved test methods.  
  • Quality System Verification: Conduct a comprehensive mock internal audit against all ISO/IEC 17025:2017 clauses and facilitate management review meetings to assess implementation progress.  
  • Accreditation Application Support: Support the compilation of the quality documentation package for submission to the Bangladesh Accreditation Board (BAB).  
  • Assessment Accompaniment: Provide ongoing support for documenting corrective actions for all nonconformities identified during the BAB pre-assessment and final assessment.  

Key Outcomes

  • Internationally Recognized Credibility: Establish recognized credibility for aquaculture diagnostics, positioning the laboratory as a reference facility for regional aquaculture health management.
  • Export Market Access: Enable direct participation in export markets that require accredited test results for product safety and disease-free certification. 
  • Technical Competence Validation: Ensure the technical competence and reliability of diagnostic methods, specifically for PCR-based pathogen detection. 
  • Robust Quality Management: Develop a comprehensive quality management system (QMS) that guarantees consistent, traceable, and scientifically defensible test results. 
  • Audit Readiness: Successfully navigate the Bangladesh Accreditation Board (BAB) assessments through rigorous preparation, training, and corrective action planning. 
  • National Regulatory Recognition: Enhance institutional credibility and gain strong recognition from Bangladeshi regulatory bodies, ensuring seamless alignment with national disease surveillance and regulatory compliance programs.
  • Platform for Scope Expansion: Serve as a robust, standardized foundational platform allowing the laboratory to easily and systematically expand its testing scope to include new parameters and matrices in the future. 
  • Enhanced Eligibility for Development Projects: Fulfill stringent pre-checking criteria and compliance standards required by international development partners, positioning the laboratory favorably to secure funding and participate in large-scale future projects. 
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