TRACE Consulting

Project Overview

Assessment of Laboratory System Strengthening and ISO/IEC 17025:2017 Accreditation Readiness: Technical Assistance for Enhancing Quality Management, Operational Efficiency, and Institutional Capacity at the Central Disease Investigation Laboratory.

Assessment and Gap Analysis
Conducted systematic assessments and gap analyses to evaluate existing laboratory systems, identify operational and compliance deficiencies, and prioritize improvement areas in alignment with international accreditation standards.
Quality Management Systems Strengthening
Developed and enhanced quality management frameworks to promote regulatory compliance, process standardization, operational consistency, and continuous quality improvement.
Integrated System Development
Designed and implemented integrated institutional systems to improve operational efficiency, interdepartmental coordination, workflow management, and data governance practices.
Technical Standards and Compliance Implementation
Facilitated the implementation of technical requirements, protocols, and compliance measures in accordance with ISO/IEC 17025:2017 and other relevant international best practices.
Documentation, Capacity Building, and Training Support
Prepared comprehensive technical documentation and delivered targeted training and capacity-building interventions to support assessment readiness, institutional learning, and sustainable system adoption.

Key Outcomes

Developed and implemented an ISO/IEC 17025:2017-compliant Quality Management System, including quality manuals, standard operating procedures (SOPs), and standardized documentation formats tailored for food and feed testing laboratories.
Established structured protocols for method verification, analytical method validation, and Measurement Uncertainty (MU) estimation for chemical and biological testing parameters in accordance with international laboratory standards.
Strengthened quality assurance practices through the establishment of metrological traceability systems, identification of proficiency testing (PT) requirements, and technical guidance on interlaboratory comparison (ILC) and PT program participation.
Implemented comprehensive equipment calibration schedules, preventive maintenance frameworks, and competency-based analyst authorization systems to ensure technical reliability and operational consistency.
Designed and executed systematic risk management approaches incorporating risk assessment, risk scoring methodologies, practical mitigation measures, and corrective action mechanisms to proactively address non-conformities and operational risks.
Conducted comprehensive Training Needs Assessments (TNA) and delivered targeted technical training and capacity-building interventions to strengthen staff competency in QMS implementation and specialized laboratory testing methodologies.
Performed baseline gap assessments, internal audits, and end-to-end accreditation preparedness activities to support compliance with Bangladesh Accreditation Board (BAB) assessment requirements and international accreditation standards.