What is ISO 13485 Lead Implementer?
The ISO 13485 Lead Implementer Course is designed to provide Learners with in-depth knowledge of ISO 13485 requirements and practical expertise in establishing and managing a QMS for the medical device industry. This course focuses on implementation strategies, risk-based approaches, and continuous improvement.
Learners will learn how to plan, implement, and maintain a compliant QMS, ensuring effective integration of quality processes into organisational operations. Practical exercises and case studies enhance learners’ ability to apply ISO 13485 principles in real-world scenarios. The course also prepares Learners for the ISO 13485 Lead Implementer certification exam.
This comprehensive 3-day ISO 13485 Lead Implementer Training Course by Oakwood International ensures professionals are well-prepared to lead implementation projects and drive QMS excellence in their organisations.
Course Objectives
To understand the purpose and benefits of ISO 13485 for medical device quality management
To learn the structure and critical requirements of the ISO 13485 standard
To develop skills for planning and implementing a QMS based on ISO 13485
To ensure Compliance with regulatory and ISO 13485 requirements
To integrate risk management principles into QMS processes
To manage documentation, policies, and procedures for effective implementation
To monitor, evaluate, and continuously improve the QMS
To prepare for ISO 13485 Lead Implementer certification
Upon completion, Learners will have the expertise to lead the implementation of ISO 13485-compliant QMS in their organisations.
Course Outline
ISO 13485 Lead Implementer
Module 1: Introduction to ISO 13485:2016
Introduction
What is ISO 13485:2016?
Benefits of Implementing ISO 13485
Applications of ISO 13485
First Steps to ISO 13485:2016 CComplianceWhat is a Medical Device?
Purpose of a Quality Management System
Importance of ISO 13485
Basic Principles of ISO 13485
Exercise
Module 2: ISO 13485 Clauses 1 and 2
Clause 1 – Scope
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 2 - Normative References
Module 3: ISO 13485 Clauses 3 and 4
Clause 3 - Terms and Definitions
Clause 4 - Quality Management System
Clause 4.1 General Requirements
Clause 4.2 Document Requirements
Exercise
Module 4: Requirements and Quality Systems
Requirements and Quality Systems
Clause 5 - Management Responsibilities
Clause 6 - Resource Management
Clause 7 - Product Realisation
Clause 8 - Measurement, Analysis, and Improvement
Exercise
Module 5: Overview of ISO 13485:2016 Requirements
Requirements of ISO 13485:2016
General Requirements
Documentation Requirements
Management Responsibility
Resources
Product Realisation
Infrastructure
Risk Management
Module 6: Implementation Phases of the ISO 13485 Frameworks
Stages to Implementation
Gap Analysis
Process Mapping
Module 7: Conducting an ISO 13485 Certification Audit
Certification Audits
Exercise
Module 8: Relationship Between ISO 13485 and ISO 9001
Scope
Focus
Continual Improvement
Terminology
Differences Between the Standards
Similarities Between the Standards
Module 9: Internal Auditing
Internal Auditing
Internal Audit Objectives
Auditing Skills
Steps in Internal Auditing
Planning, Preparation, and Management of Audits
Internal Audit – PDCA Cycle
Types of Audit
Audit Techniques
Exercise
Module 10: Internal Audit Plan
Audit Plan
Criteria
Module 11: Audit Process
Audit Process
Conducting Process Audits
Scope
Criteria
Reporting Audit Findings
Module 12: Internal Audit Evidence and Findings
Internal Audit Evidence and Findings
Classification
Closing Report
Nonconformities
Documented Procedure
Exercise
Module 13: Roles and Responsibilities
Internal Auditor Responsibilities
Closing Meetings
Module 14: Resource Management and Product Realisation
Provision of Resources
Infrastructure
Planning and Development of Products
Module 15: ISO 13485 and Quality Management Systems
ISO 13485
Quality Management Systems (QMS)
Exercise
Module 16: Principles of Quality Management System
Principles of QMS
Exercise
Module 17: Fundamentals of Quality Management Systems
Fundamentals of Quality Management Systems
Module 18: Measurement, Analysis, and Improvement
Measurement, Analysis, and Improvement
General Requirements
Monitoring and Measurement
Control of Nonconforming Product
Performance of QMS
Analysis of Data
Improvement
Corrective Action
Preventive Action
Identification of Improvement Opportunities
Module 19: Risk Management
Risk Management
Risk Management Principle
Risk Management Process
Risk Lifecycle
Risk Management Tools
Risk Management Culture
Assessments and Control of Risk Management
Exercise
Included
Included
- No course includes are available.
Offered In This Course:
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Video Content
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eLearning Materials
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Study Resources
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Completion Certificate
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Tutor Support
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Interactive Quizzes
Learning Options
Discover a range of flexible learning options designed to meet your needs. Select the format that best supports your personal growth and goals.
Online Instructor-Led Training
- Live virtual classes led by experienced trainers, offering real-time interaction and guidance for optimal learning outcomes.
Online Self-Paced Training
- Flexible learning at your own pace, with access to comprehensive course materials and resources available anytime, anywhere.
Build your future with Oakwood International
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Frequently Asked Questions
Q. What topics are covered in the ISO 13485 Lead Implementer Course?
The course covers QMS planning, implementation, risk management,
monitoring, continuous improvement, and certification preparation.
Q. How can this training benefit my career?
ISO 13485 Lead Implementer certification validates your
expertise in implementing quality management systems, advancing your career in
quality assurance and regulatory Compliance
Q. Is ISO 13485 applicable globally?
Yes, ISO 13485 is recognised internationally and aligns with
various global medical device regulations.
Q. What support is provided during the training?
Learners receive comprehensive study materials, practical
exercises, and expert instructor guidance to ensure effective learning and
certification readiness.
Q. Is this course suitable for beginners?
No, this course is designed for professionals with prior
knowledge of ISO 13485 or experience in quality management systems,
particularly those who have completed ISO 13485 Foundation training.