IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 9001B — Quality Management in Biotech Labs
REF: HL-BIO-9001B
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 ISO 9001B Principles in Biotech Leadership
Creating a Quality Management Framework in Biotechnology
Driving Continuous Improvement through Leadership in Biotech
Risk Management and Decision-Making in Quality Management
Leading Change: Adapting to ISO 9001B in Dynamic Biotech Environments
2 Process Improvement Strategies 5 chapters · 75 marks
Understanding Process Improvement in Biotech Labs
Key Methodologies for Process Improvement
Identifying and Analyzing Process Inefficiencies
Implementing Process Changes Effectively
Evaluating and Sustaining Process Improvements
3 Data Analysis Techniques 5 chapters · 75 marks
Understanding Data Types and Their Relevance in Biotech Labs
Data Collection Methods: Designing Effective Protocols
Statistical Tools for Data Analysis in Biotechnology
Visualizing Data: Best Practices for Biotech Reports
Interpreting Results: Making Data-Driven Decisions in Biotech
4 Regulatory Compliance 5 chapters · 100 marks
Understanding Regulatory Frameworks in Biotechnology
ISO 9001 Standards Overview and Application
Quality Management Systems: Design and Implementation
Compliance Monitoring and Auditing Techniques
Continuous Improvement Strategies in Regulatory Compliance
5 Quality Management Systems 5 chapters · 125 marks
Foundations of Quality Management Systems in Biotech
ISO 9001B Standards and Frameworks
Implementing Quality Management Processes
Auditing and Assessing Quality Compliance
Continuous Improvement and Quality Culture in Biotech Labs
6 ISO 9001 Fundamentals 5 chapters · 75 marks
Understanding ISO 9001: The Foundation of Quality Management
Key Components of ISO 9001: Structure and Requirements
Context of the Organization: Identifying Needs and Expectations
Quality Objectives and Planning: Setting and Achieving Goals
Continuous Improvement in Biotechnology: Beyond Compliance
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

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ISO 9001B — Quality Management in Biotech Labs