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:

  • vedio Video Content
  • elearning eLearning Materials
  • exam Study Resources
  • certificate Completion Certificate
  • study Tutor Support
  • workbook Interactive Quizzes
Individual Training

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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.

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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.

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