📄 ISO 15189 — Medical Laboratories Requirements for Quality — Certification Brochure
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IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 15189 — Medical Laboratories Requirements for Quality
REF: HL-BIO-15189
12
Subjects
1000
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Project Management in Quality Systems 5 chapters · 75 marks
Understanding ISO 15189 and Its Importance in Medical Laboratories
Project Management Fundamentals in Quality Systems
Planning for Quality: Defining Project Goals and Objectives
Risk Management in Quality Projects: Identifying and Mitigating Risks
Monitoring and Evaluation: Ensuring Quality Throughout the Project Lifecycle
2 Continuous Improvement Strategies 5 chapters · 75 marks
Understanding Continuous Improvement in Medical Laboratories
Key Principles of Continuous Improvement Frameworks
Data Collection and Analysis for Improvement
Implementing Change in Laboratory Settings
Measuring the Impact of Continuous Improvement Initiatives
3 Leadership and Team Management 5 chapters · 50 marks
Understanding Leadership in Medical Laboratories
Styles and Theories of Leadership in Biotechnology
Building Effective Teams in a Laboratory Environment
Conflict Resolution and Problem Solving in Teams
Leadership for Continuous Improvement and Compliance
4 Risk Management in Laboratories 5 chapters · 100 marks
Understanding Risk in Medical Laboratories
Identifying and Assessing Risks in Laboratory Processes
Developing Risk Mitigation Strategies
Monitoring and Reviewing Risk Management Practices
Integrating Risk Management with Laboratory Quality Systems
5 ISO 15189 Compliance 5 chapters · 100 marks
Understanding ISO 15189: Standards and Scope in Medical Laboratories
Quality Management Systems and Leadership Roles
Document Control and Compliance Protocols
Monitoring and Measuring Quality Performance
Managing Non-Conformities and Continuous Improvement
6 Quality Management Principles 5 chapters · 100 marks
Foundations of Quality Management in Medical Laboratories
ISO 15189 Standards and Compliance Requirements
Leadership Roles in Quality Management
Risk Management and Continuous Improvement
Evaluating Performance and Enhancing Quality Outcomes
7 Leadership and Team Development 5 chapters · 75 marks
Understanding Leadership Roles in Medical Laboratories
Developing Effective Team Dynamics in a Laboratory Setting
Implementing Quality Management Systems through Leadership
Navigating Change and Innovation in Laboratory Practices
Evaluating Team Performance and Leadership Effectiveness
8 Risk Management in Laboratories 5 chapters · 75 marks
Understanding Risk Management Principles in Laboratories
Regulatory Framework and ISO 15189 Standards in Risk Management
Risk Assessment Techniques for Laboratory Processes
Implementing Risk Mitigation Strategies in Laboratories
Monitoring and Reviewing Risk Management Plans
9 Quality Control and Assurance 5 chapters · 100 marks
Fundamentals of Quality Control in Medical Laboratories
ISO 15189 Standards: Structure and Key Requirements
Implementing Quality Assurance Protocols
Assessing and Monitoring Quality Indicators
Continuous Improvement and Auditing in Quality Systems
10 Laboratory Operations Management 5 chapters · 75 marks
Fundamentals of ISO 15189 and Its Importance in Laboratories
Quality Management Systems and Leadership Roles in Laboratories
Document Control and Records Management in Compliance with ISO 15189
Risk Management Strategies for Medical Laboratories
Continuous Improvement and Audits in Laboratory Quality Management
11 Regulatory Frameworks 5 chapters · 75 marks
Understanding ISO 15189: The Framework for Quality in Medical Laboratories
Key Regulatory Bodies and Their Roles in ISO Compliance
Documentation and Quality Management Systems in Medical Laboratories
Risk Management and Internal Auditing Practices
Continuous Improvement Strategies for ISO 15189 Accreditation
12 Quality Management Systems 5 chapters · 100 marks
Understanding ISO 15189: An Overview of Requirements
Key Elements of Quality Management Systems in Laboratories
Leadership and Management Responsibilities in Quality Assurance
Documentation and Record-Keeping in Compliance with ISO 15189
Continuous Improvement and Internal Audits for Quality Enhancement
Assessment Breakdown

Passing Mark: 650 / 1000 (65%)

How to Enrol

Website: lapt.org

Email: info@lapt.org

Phone: +44 7513 283044

Address: 85 Great Portland Street, W1W 7LT, United Kingdom

Hours: Monday – Friday, 9AM – 5PM

LAPT — London Academy of Professional Training
Master Certificate | Leadership | Level 6-7
Ref: HL-BIO-15189
lapt.org
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ISO 15189 — Medical Laboratories Requirements for Quality