What is ISO 13485 Lead Auditor?

The ISO 13485 Lead Auditor Training is designed to provide Learners with in-depth knowledge of auditing principles, processes, and techniques required to lead and manage QMS audits in the medical device industry. This course enables learners to ensure organisational Compliance and drive continuous improvement.

Learners will learn how to plan, execute, and report on audits effectively while mastering interpersonal and communication skills necessary for audit leadership. The course prepares learners to conduct both internal and external audits, as well as third-party certification audits. 

This comprehensive 5-day ISO 13485 Lead Auditor Training Course by Oakwood International ensures professionals are well-prepared to lead audits, enhance QMS processes, and achieve ISO 13485 compliance in their organisations.
 

Course Objectives
 

  • To understand the principles and purpose of ISO 13485 and its role in QMS auditing
  • To learn the structure and critical requirements of the ISO 13485 standard
  • To develop skills to lead and manage QMS audits effectively
  • To master the techniques for planning, conducting, and reportin audits
  • To ensure Compliance with regulatory and ISO 13485 requirements
  • To gain expertise in identifying and addressing nonconformities
  • To improve communication and leadership skills for audit management
  • To prepare for certification as an ISO 13485 Lead Auditor

Upon completion, Learners will be equipped to confidently lead QMS audits, ensuring Compliance and fostering continuous improvement within organisations.

Course Outline

ISO 13485 Lead Auditor

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 Compliance
  • What 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
     

Module 20: Key Terms and Definitions of Lead Auditor

  • Key Terms Definitions
     

Module 21: Lead Auditor Responsibilities

  • Lead Auditor Responsibilities
  • Auditing Organisation
  • Auditees
     

Module 22: Team Leader Skills

  • Team Leader Skills
  • Exercise
     

Module 23: Structure and Intent of ISO 13485

  • Structure and Intent
  • Clause 5 – Management Responsibility
  • Clause 6 – Resource Management
  • Clause 7 – Product Realisation
  • Clause 8 – Measurement, Analysis, and Improvement
     

Module 24: Medical Devices, Quality, and Auditing Terminology

  • Medical Devices
  • Quality Management System
  • Auditing Terminology
  • Exercise
     

Module 25: Processes, Procedures, and Records

  • Processes
  • Procedure
  • Records
     

Module 26: Checklist Development

  • Purpose
  • Completed Checklist Provides
  • Process Based Audits
  • Checklist
  • Process Checklist
     

Module 27: Planning, Preparation, and Management of Audits

  • Planning
  • Preparation
  • Management of Audits
  • Exercise
     

Module 28: Interviewing Skills

  • Key Interviewing Skills
  • Star Technique
     

Module 29: Corrective Action and Verification

  • Overview
  • Corrective Action
  • Documented Procedure
  • Process
     

Module 30: Preventative Action

  • Overview
  • Preventive Action: Process
  • Exercise and Questions

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
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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 Auditor Training?

The course covers auditing principles, ISO 13485 requirements, audit planning, execution, reporting, nonconformity management, and certification preparation.

Q. How can this training benefit my career?

ISO 13485 Lead Auditor certification validates your quality management system auditing expertise, advancing your career in regulatory Compliance and quality assurance roles.

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 a thorough understanding of auditing concepts 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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