Introduction

In today's highly regulated healthcare, pharmaceutical, biotechnology, environmental, food safety, and research sectors, implementing a robust Laboratory Quality Management System (LQMS) is essential for ensuring accuracy, reliability, compliance, traceability, and continual improvement. Organizations are increasingly adopting international standards such as ISO 15189, ISO/IEC 17025, Good Laboratory Practice (GLP), CAP Accreditation, Risk-Based Thinking, Digital Quality Management, and Data Integrity Frameworks to enhance laboratory performance and maintain stakeholder confidence. Effective quality management reduces errors, improves turnaround times, strengthens customer satisfaction, and supports evidence-based decision-making.

Laboratory Quality Management Systems (LQMS) Training Course equips laboratory professionals with practical skills and advanced knowledge to establish, implement, monitor, audit, and continually improve laboratory quality systems. Participants will learn best practices in quality assurance, quality control, laboratory accreditation, root cause analysis, risk management, competency assessment, corrective and preventive actions (CAPA), laboratory digital transformation, and regulatory compliance. Through real-world case studies and hands-on exercises, attendees will gain the competencies needed to drive operational excellence and achieve international laboratory standards.

Programme Curriculum

Laboratory Quality Management Systems (LQMS) Training Course

Introduction

Course Duration

5 days

Course Objectives

Upon completion of this course, participants will be able to:

Understand the principles of Laboratory Quality Management Systems (LQMS).
Interpret requirements of ISO 15189 and ISO/IEC 17025 standards.
Implement effective Quality Assurance (QA) and Quality Control (QC) programs.
Apply Risk-Based Thinking for laboratory process improvement.
Develop and manage laboratory documentation and SOP systems.
Strengthen Data Integrity and Digital Quality Management practices.
Conduct internal quality audits using modern auditing techniques.
Perform Root Cause Analysis (RCA) and implement CAPA programs.
Establish laboratory performance indicators and quality metrics.
Enhance laboratory accreditation readiness and compliance management.
Improve sample management, traceability, and chain-of-custody processes.
Integrate continuous improvement methodologies such as Lean Laboratory Management and Six Sigma.
Build a culture of quality, patient safety, and operational excellence.

Target Audience

Laboratory Managers and Supervisors
Quality Assurance Officers
Medical Laboratory Scientists
Laboratory Technologists and Technicians
Quality Control Personnel
Research Scientists and Analysts
Accreditation and Compliance Officers
Healthcare, Pharmaceutical, Food Safety, Environmental, and Biotechnology Professionals

Course Modules

Module 1: Foundations of Laboratory Quality Management Systems

Principles of Quality Management Systems
Quality Standards and Regulatory Requirements
Quality Policy and Quality Objectives
Laboratory Organizational Structure
Quality Culture and Leadership
Case Study: Implementing an ISO-based quality system in a regional diagnostic laboratory.

Module 2: ISO 15189, ISO/IEC 17025 and Accreditation Requirements

Overview of ISO 15189 Requirements
ISO/IEC 17025 Compliance Framework
Accreditation Processes and Readiness
Gap Analysis Techniques
Regulatory and Legal Considerations
Case Study: Laboratory accreditation journey and lessons learned.

Module 3: Quality Assurance and Quality Control

Internal Quality Control Systems
External Quality Assessment Programs
Method Validation and Verification
Measurement Uncertainty
Performance Monitoring and Benchmarking
Case Study: Reducing analytical errors through strengthened QC processes.

Module 4: Laboratory Documentation and Data Integrity

Standard Operating Procedures (SOPs)
Document Control Systems
Record Management and Traceability
Electronic Laboratory Information Systems (LIMS)
ALCOA+ Data Integrity Principles
Case Study: Transitioning from paper-based records to digital quality systems.

Module 5: Risk Management and Continuous Improvement

Risk Assessment Methodologies
Risk Registers and Mitigation Plans
Lean Laboratory Management
Six Sigma Quality Improvement
Continuous Improvement Frameworks
Case Study: Applying Lean principles to reduce sample turnaround times.

Module 6: Internal Auditing and CAPA Management

Audit Planning and Execution
Audit Reporting Techniques
Root Cause Analysis Tools
Corrective and Preventive Actions (CAPA)
Follow-up and Effectiveness Evaluation
Case Study: Managing recurring non-conformities through CAPA implementation.

Module 7: Competency Assessment and Quality Leadership

Staff Competency Management
Training and Development Programs
Performance Evaluation Systems
Leadership in Quality Management
Change Management Strategies
Case Study: Building a high-performance laboratory quality culture.

Module 8: Laboratory Performance Excellence and Future Trends

Key Performance Indicators (KPIs)
Quality Dashboards and Analytics
Artificial Intelligence in Laboratory Quality
Digital Transformation and Automation
Strategic Quality Planning
Case Study: Leveraging digital quality tools to improve laboratory efficiency and compliance.

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

Interactive lectures and presentations.
Group discussions and brainstorming sessions.
Hands-on exercises using real-world datasets.
Role-playing and scenario-based simulations.
Analysis of case studies to bridge theory and practice.
Peer-to-peer learning and networking.
Expert-led Q&A sessions.
Continuous feedback and personalized guidance.

Register as a group from 3 participants for a Discount

Send us an email: info@fineskilltrainingcenter.org or call +254769199797

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to Fineskill Training Center account, as indicated in the invoice so as to enable us prepare better for you.

Skills & Software Covered

Quality assurance systems Method validation Documentation control Audit compliance

Programme Fee

Duration: 5 Days

Method: Online or Physical

Online Price: $1,000

Physical Price: $1,500

Certification: Accredited Certificate

View Available Dates 📄 Download Course Outline (PDF)

Available Sessions

Location

Month

Year

Oct 26 2026

26 Oct — 30 Oct 2026

💻 Online / Virtual session

Online $1,000