📄 ISO 17511 — In Vitro Diagnostic Medical Devices Metrological Traceability — Certification Brochure
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IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 17511 — In Vitro Diagnostic Medical Devices Metrological Traceability
REF: HL-BIO-17511
6
Subjects
500
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Strategic Planning for Continuous Improvement 5 chapters · 75 marks
Understanding Metrological Traceability in IVDs
ISO 17511: Key Requirements and Implementation
Strategic Planning Framework for Continuous Improvement
Performance Metrics and Evaluation in IVDs
Cultivating a Culture of Quality and Improvement
2 Stakeholder Engagement and Communication 5 chapters · 75 marks
Understanding the Landscape of Stakeholder Engagement in ISO 17511
Identifying and Mapping Stakeholders in In Vitro Diagnostics
Effective Communication Strategies for Stakeholder Involvement
Developing Stakeholder Engagement Plans for Compliance
Evaluating and Measuring Stakeholder Engagement Outcomes
3 Leadership and Change Management 5 chapters · 50 marks
Understanding Leadership Theories in Biomedical Contexts
The Role of Change Management in ISO 17511 Implementation
Building Effective Leadership Teams in Biotechnology
Navigating Regulatory Changes and Stakeholder Engagement
Strategic Leadership for Sustaining Change in ISO Compliance
4 Regulatory Compliance and Risk Management 5 chapters · 75 marks
Understanding ISO 17511: Principles and Framework
Regulatory Landscape for In Vitro Diagnostic Devices
Metrological Traceability in Diagnostic Testing
Risk Management Strategies in Regulatory Compliance
Implementing Compliance and Risk Management Systems
5 Quality Assurance in Biotechnology 5 chapters · 125 marks
Fundamentals of Quality Assurance in Biotechnology
Understanding ISO 17511 and Metrological Traceability
Implementing Quality Management Systems in Biotech
Risk Management in Quality Assurance Processes
Continuous Improvement and Auditing Practices
6 Metrological Principles and Standards 5 chapters · 100 marks
Fundamentals of Metrological Concepts in Healthcare
Measurement Uncertainty and Its Role in Diagnostics
Metrological Traceability and Its Standards
Calibration Protocols for Diagnostic Instruments
Quality Assurance in Metrological Practices
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-BIO-17511
lapt.org
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ISO 17511 — In Vitro Diagnostic Medical Devices Metrological Traceability