📄 ISO 13485 — Medical Devices Quality Management Systems — Certification Brochure
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IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 13485 — Medical Devices Quality Management Systems
REF: HL-EQP-13485
6
Subjects
500
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Leadership in Quality Management 5 chapters · 50 marks
Understanding Leadership Roles in Quality Management Systems for Medical Devices
Regulatory Landscape and its Impact on Leadership in ISO 13485
Building a Quality-Driven Culture within Medical Device Organizations
Leadership Strategies for Effective Risk Management in Quality Assurance
Driving Continuous Improvement through Leadership in Quality Management
2 Continuous Improvement Strategies 5 chapters · 100 marks
Understanding Continuous Improvement Principles in Healthcare
Key Methodologies for Continuous Improvement in Medical Devices
Data-Driven Decision Making for Quality Enhancement
Implementing Continuous Improvement Initiatives in ISO 13485
Evaluating and Sustaining Continuous Improvement Outcomes
3 Quality Control Techniques 5 chapters · 50 marks
Fundamentals of Quality Control in Medical Devices
Statistical Techniques for Quality Control
Quality Control Tools and Techniques
Implementing Quality Control in Medical Device Processes
Continuous Improvement and Quality Control in ISO 13485
4 Regulatory Compliance and Risk Management 5 chapters · 100 marks
Understanding Regulatory Frameworks for Medical Devices
ISO 13485 Essentials: Quality Management Systems in Healthcare
Risk Management Principles in Medical Device Development
Implementing Risk Management Processes per ISO 14971
Auditing and Continuous Improvement in Regulatory Compliance
5 Quality Management Principles 5 chapters · 100 marks
Foundations of Quality Management in Medical Devices
ISO 13485 Standards: Structure and Requirements
Risk Management in Quality Management Systems
Leadership and Continual Improvement in QMS
Auditing and Compliance for Medical Devices QMS
6 Introduction to ISO 13485 5 chapters · 100 marks
Foundations of ISO 13485: Understanding Quality Management Systems in Medical Devices
Key Principles and Terminology of ISO 13485
Document Control and Record Management in ISO 13485
Roles and Responsibilities in ISO 13485 Implementation
Internal Audits and Continuous Improvement in ISO 13485
Assessment Breakdown

Passing Mark: 325 / 500 (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-EQP-13485
lapt.org
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ISO 13485 — Medical Devices Quality Management Systems