Technical Assistance for ISO/IEC 15189:2022 Accreditation of Rodolphe Mérieux Laboratory, BITID
Project Overview
TRACE Consulting has been engaged by the Mérieux Foundation, a France-based international organization to provide technical assistance for ISO/IEC 15189:2022 accreditation of the Rodolphe Mérieux Laboratory, based within the Bangladesh Institute of Tropical & Infectious Diseases (BITID) in Chittagong. The Rodolphe Mérieux Laboratory, established by the Mérieux Foundation in partnership with BITID in 2015, is a center of excellence for applied research, training, and biological analysis in Bangladesh, with a focus on tuberculosis, respiratory infections, and enteric diseases. It is part of the Mérieux Foundation's global GABRIEL Network of laboratories.
The assignment supports the laboratory's preparation for ISO/IEC 15189:2022 accreditation-the internationally recognized standard for medical laboratory quality and competence-by assessing its status, building an internationally recognized quality management system, and strengthening the technical competence of laboratory personnel. The engagement contributes to the Mérieux Foundation's broader, long-standing effort to strengthen Bangladesh's national laboratory system and improve access to quality diagnostics.
Project Phases
Scope of Work
- Action plan development as per Gap Assessment: 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.
- Quality Management System (QMS) Documentation: 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.
- Technical Requirements Implementation: 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.
- Quality System Verification: 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.
- Accreditation Application Support: Supporting compilation of the laboratory's quality documentation package for submission to the Bangladesh Accreditation Board (BAB).
- Pre-Assessment and Final Assessment Accompaniment: 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.
