Back to All Projects
Laboratory Improvement Ongoing

Technical Assistance for ISO/IEC 15189:2022 Accreditation of Rodolphe Mérieux Laboratory, BITID

Client: Fondation Mérieux, France

Project Overview

The Rodolphe Mérieux Laboratory (RML), located at the Bangladesh Institute of Tropical and Infectious Diseases (BITID) in Foujdarhat, Chattogram, is a specialized infectious disease center operating under the Government of Bangladesh’s Health, Population and Nutrition Sector Program (HNPSP). Established in 2015 by Fondation Mérieux, RML plays a vital role in disease surveillance, outbreak detection, and clinical diagnostics, focusing on tuberculosis, respiratory infections, and enteric diseases. As a member of the Foundation’s global GABRIEL Network, it also contributes to applied research, training, and biological analysis. 

 

Fondation Mérieux has engaged TRACE Consulting to provide technical assistance for ISO 15189:2022 accreditation, the international benchmark for medical laboratory quality and competence.  
 

TRACE’s assignment is strategically critical to preparing RML for ISO 15189:2022 accreditation, the internationally recognized benchmark for medical laboratory quality, technical competence, and reliability of diagnostic results. The assignment encompasses a comprehensive gap assessment against the standard’s requirements; the systematic analysis of identified deficiencies; the establishment of a robust, fully documented Quality Management System (QMS), supported by prioritized corrective actions and a structured implementation roadmap; and the strengthening of laboratory personnel’s technical competence through targeted capacity building, standardized procedures, and effective quality assurance practices. 
 

The project aims to prepare RML for formal assessment by the Bangladesh Accreditation Board (BAB) and support its pathway toward internationally recognized ISO 15189:2022 accreditation. This will enhance diagnostic accuracy, patient safety, reduce turnaround times for high-consequence pathogen testing, and strengthen national preparedness for emerging infectious diseases. 

Project Scopes

  • Consolidating and categorizing gap findings against ISO/IEC 15189:2022 clauses, conducting root cause analyses, and developing an approved strategic roadmap and corrective action plan.
  • Developing a full four-tier documentation structure-top-level policies and the Quality Manual, system-level procedures (document control, risk management, nonconformity and corrective action, internal audits, complaints), technical SOPs covering the full testing workflow (pre-examination, examination, post-examination, LIMS/equipment operation), and standardized formats, logs, and registers.
  • Building personnel competence through structured training and live practice in equipment traceability and calibration, internal quality control (IQC) and external quality assessment (EQA), method verification, measurement uncertainty calculation, and risk and nonconformity management.
  • Conducting a comprehensive mock internal audit against ISO/IEC 15189:2022 clauses, generating corrective action and nonconformity reports with root-cause analysis, and facilitating management review meetings.
  • Supporting compilation of the laboratory's quality documentation package for submission to the Bangladesh Accreditation Board (BAB).
  • Supporting documentation of corrective actions for nonconformities identified during both the BAB pre-assessment and final assessment stages.

Key Outcomes

  • Approved Strategic Roadmap and Corrective Action Plan aligned to ISO/IEC 15189:2022 gap findings.
  • A complete QMS documentation set, including the quality manual, system procedures, technical SOPs, and a master index of standardized formats and records.
  • A trained and competent laboratory workforce, with documented competency assessments, method verification reports, measurement uncertainty calculations, and IQC/EQA performance records.
  • A verified quality system, evidenced by an internal audit report, corrective action requests with root-cause analysis, and management review minutes.
  • Accreditation assessment readiness, supported through pre-assessment and final assessment corrective action cycles.
WORK WITH US

Have a project in mind? Let's build something that lasts

Whether reforming a regulatory system, building technical
capacity, or modernising digital infrastructure, we would like to
hear from you.