The Quality and Laboratory Management Training Course provides participants with the essential knowledge, tools, and strategies required to manage modern laboratory operations effectively and ensure compliance with international standards. This course covers the principles of quality management systems (QMS), laboratory accreditation requirements, method validation, equipment management, documentation control, internal auditing, risk-based thinking, and continuous improvement.

Designed for laboratory supervisors, analysts, quality managers, auditors, and technical personnel, the course blends practical case studies with globally recognized frameworks such as ISO/IEC 17025, ISO 9001, GLP, and GMP. Participants gain hands-on experience in managing laboratory workflows, maintaining data integrity, ensuring traceability, and implementing robust quality control systems that support reliable and defensible analytical results.

By the end of the program, attendees will be able to establish a structured laboratory quality management system, evaluate laboratory performance, improve operational efficiency, and maintain compliance with regulatory and accreditation criteria.

Course Outline

Module 1: Foundations of Quality and Laboratory Management

• Introduction to quality management principles

• Roles and responsibilities in laboratory operations

• Importance of laboratory quality systems

• Regulatory and accreditation frameworks (ISO/IEC 17025, ISO 15189, GLP, GMP)

Module 2: Quality Management Systems (QMS) in the Laboratory

• Structure and components of a laboratory QMS

• Documentation hierarchy: policies, SOPs, forms, and records

• Document control and version management

• Quality manual development

Module 3: Laboratory Operations and Workflow Management

• Sample receipt, handling, and chain of custody

• Laboratory scheduling, planning, and workload balancing

• Method development and validation principles

• Outsourcing, sub-contracting, and supplier evaluations

Module 4: Measurement Traceability and Equipment Management

• Calibration and verification of equipment

• Instrument qualification (IQ, OQ, PQ)

• Reference materials and standards

• Measurement uncertainty basics

Module 5: Quality Control and Data Integrity

• Internal quality control (IQC) processes

• External quality assessments (EQA) and proficiency testing

• Data integrity principles (ALCOA+)

• Preventing laboratory errors and managing non-conformities

Module 6: Risk Management and Continuous Improvement

• Risk-based thinking in laboratory management

• Root cause analysis techniques (Fishbone, 5 Why’s, FMEA)

• CAPA: Corrective and Preventive Actions

• Continual improvement tools (Kaizen, Lean Lab principles)

Module 7: Laboratory Audits and Accreditation

• Internal audit processes

• Audit planning, execution, and reporting

• Preparing for external audits (accreditation/ regulatory)

• Audit follow-up and corrective action tracking

Module 8: Leadership, Ethics, and Communication in the Laboratory

• Ethical laboratory practices

• Supervisory and leadership skills for laboratory managers

• Communication and team coordination

• Change management in laboratory settings

Course Objectives

By the end of the course, participants will be able to:

1. Understand and apply core principles of quality and laboratory management.

2. Develop, implement, and maintain an effective quality management system.

3. Ensure laboratory compliance with international standards such as ISO/IEC 17025.

4. Optimize laboratory workflows for maximum efficiency and reliability.

5. Implement robust quality control systems and ensure data integrity.

6. Manage laboratory equipment, calibration, and measurement traceability.

7. Apply risk-based thinking to minimize errors and improve operational performance.

8. Conduct internal audits and prepare for external accreditation assessments.

9. Lead laboratory teams with professionalism, ethics, and effective communication.

Learning Outcomes

At the end of this training, participants will be able to:

• Design and maintain a laboratory quality management system aligned with ISO/IEC 17025 or relevant standards.

• Create and manage SOPs, quality manuals, and documentation systems effectively.

• Evaluate laboratory performance using QC tools, audit findings, and risk assessments.

• Demonstrate proficiency in method validation, equipment qualification, and traceability practices.

• Identify and correct non-conformities using structured root-cause analysis and CAPA processes.

• Enhance laboratory efficiency through improved workflow planning and resource management.

• Prepare and lead internal audits and respond effectively to external regulatory audits.

• Promote a culture of quality, ethics, and continuous improvement within the laboratory environment.