Course Duration
1 Day
Course Overview
This course provides participants with a comprehensive introduction to ISO 15189 — the international standard that specifies requirements for quality and competence in medical laboratories. The training is designed to create awareness of the standard’s structure, principles, requirements, and implementation benefits within laboratory environments.
Participants will gain an understanding of laboratory quality management systems, risk-based thinking, competence requirements, and continual improvement principles applicable to medical laboratories.
Course Objectives
At the end of this course, participants will be able to:
- Understand the purpose and scope of ISO 15189.
- Explain the structure and key clauses of ISO 15189.
- Understand the principles of quality management in medical laboratories.
- Recognize the competence requirements for laboratory personnel and processes.
- Identify the documentation and operational requirements of ISO 15189.
- Understand risk management and continual improvement concepts within laboratory systems.
- Appreciate the benefits of accreditation and compliance with ISO 15189.
- Understand the roles and responsibilities of laboratory personnel in maintaining quality and competence.
Target Audience
This course is suitable for:
- Medical laboratory personnel
- Laboratory managers and supervisors
- Quality managers and quality officers
- Pathologists and laboratory scientists
- Internal auditors
- Healthcare professionals involved in laboratory services
- Regulatory and compliance personnel
- Laboratory consultants
- Individuals seeking basic knowledge of ISO 15189
Course Content
Module 1: Introduction to ISO 15189
- Overview of ISO standards
- Purpose and benefits of ISO 15189
- Scope and application of the standard
- Relationship with accreditation bodies
Module 2: Fundamentals of Quality Management Systems
- Quality management principles
- Process approach in laboratories
- Risk-based thinking
- Continual improvement concepts
Module 3: Structure of ISO 15189
- Overview of clauses and requirements
- Management requirements
- Technical requirements
- Key terminology and definitions
Module 4: Management Requirements
- Document and record control
- Organizational structure and responsibilities
- Corrective and preventive actions
- Internal audits and management reviews
Module 5: Technical Requirements
- Personnel competence
- Equipment calibration and maintenance
- Examination processes
- Sample handling and traceability
- Assuring quality of examination results
Module 6: Laboratory Risk and Quality Assurance
- Risk identification and mitigation
- Nonconformity management
- Quality indicators
- Patient safety and confidentiality
Module 7: Accreditation and Implementation Awareness
- Steps toward ISO 15189 implementation
- Accreditation process overview
- Common implementation challenges
- Benefits of compliance and accreditation
Module 8: Course Review and Assessment
- Interactive discussions
- Case studies
- Questions and answers
- Course evaluation
Training Methodology
The course will be delivered using highly interactive and practical approaches, including:
- Instructor-led presentations
- Group discussions
- Practical examples and case studies
- Interactive question-and-answer sessions
- Workshop exercises
- Real-life laboratory scenarios
- Knowledge assessment quizzes
Self Study: Free (Material, Examination and Certificate ) – Offer Ends 30th June, 2026
Online- £1500 for a group of 10 or more
Registration: Send name, email address and course title to info@iscbonline.com
