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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, the analytical wing of Fishtech (BD) Limited in Khulna, is a pioneering private-sector facility and Bangladesh’s first private real-time PCR-based molecular laboratory dedicated to fish and shrimp health. Serving farmers, hatcheries, and the wider aquaculture industry, it provides critical diagnostic and environmental testing services to strengthen disease management, biosecurity, and production sustainability. To enhance analytical competence and international credibility, TRACE Consulting is providing comprehensive technical assistance to establish and implement a Quality Management System (QMS) aligned with ISO/IEC 17025:2017. 
 

The assignment includes a systematic assessment of the laboratory’s molecular, microbiological, and physicochemical testing capabilities; identification of critical compliance gaps; development and implementation of quality documentation and method validation protocols for key aquaculture pathogens like Vibrio species; equipment calibration and maintenance controls; international Proficiency Testing (PT) sourcing; hands-on personnel training; and internal audit preparation. This structured accreditation roadmap aims to prepare Fishtech Laboratory for formal assessment by the Bangladesh Accreditation Board (BAB), strengthen diagnostic reliability and hatchery biosecurity, protect farmers against preventable production losses, and support national disease surveillance and the international competitiveness of Bangladesh’s aquaculture and seafood sectors. 

Project Scopes

  • 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.
  • Develop a comprehensive quality manual, quality policy, technical SOPs, and required forms aligned with ISO/IEC 17025:2017 requirements.
  • Deliver hands-on awareness training on ISO/IEC 17025 fundamentals, risk assessment methodologies, method validation, and measurement uncertainty calculation for all approved test methods.
  • Conduct a comprehensive mock internal audit against all ISO/IEC 17025:2017 clauses and facilitate management review meetings to assess implementation progress.
  • Support the compilation of the quality documentation package for submission to the Bangladesh Accreditation Board (BAB).
  • Provide ongoing support for documenting corrective actions for all nonconformities identified during the BAB pre-assessment and final assessment.

Expected Outcomes

  • Establish recognized credibility for aquaculture diagnostics, positioning the laboratory as a reference facility for regional aquaculture health management.
  • Enable direct participation in export markets that require accredited test results for product safety and disease-free certification.
  • Ensure the technical competence and reliability of diagnostic methods, specifically for PCR-based pathogen detection.
  • Develop a comprehensive quality management system (QMS) that guarantees consistent, traceable, and scientifically defensible test results.
  • Successfully navigate the Bangladesh Accreditation Board (BAB) assessments through rigorous preparation, training, and corrective action planning.
  • Enhance institutional credibility and gain strong recognition from Bangladeshi regulatory bodies, ensuring seamless alignment with national disease surveillance and regulatory compliance programs.
  • 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.
  • 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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