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Course Information

ISO 13485 Lead Auditor Training Course Outline

 

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

  • Clauses 1 - Scope
  • Clauses 5 - Management Responsibility
  • Clauses 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
  • Clause 6
  • Clause 7
  • Clause 8
  • 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

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Prerequisites

There are no formal prerequisites for attending this ISO 13485 Lead Auditor Training course.

Audience

This course is designed for everyone who wishes to advance their knowledge of implementing quality management systems for medical devices and managing auditing to improve the overall performance of an organisation.

ISO 13485 Lead Auditor Training Course Overview

ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. Studying this training provides learners with the implementation of a quality management system for medical devices and methods to conduct auditing activities to ensure the overall performance of an organisation. Obtaining knowledge of this training assists organisations in eliminating problems and reducing the work burden. Individuals who pursue this training can better acquire the knowledge and abilities that will ultimately expand their employment options and raise their income.

The Knowledge Academy’s 5-day ISO 13485 Lead Auditor Training course provides delegates with comprehensive knowledge of quality management and how to audit the system. During this training, delegates will learn about the implementation phases of ISO frameworks and the gap analysis for support information for several clauses. They will also learn about risk management for mapping identified risks and monitoring continuous improvement. This course will be led by our highly skilled and knowledgeable instructor with years of experience teaching ISO courses.  

Course Objectives

  • To improve the quality of medical devices manufactured by a company
  • To promote harmonisation of regulatory requirements for manufacturers
  • To provide access and evidence in accordance with regulatory requirements
  • To engage management actively and undertake management system activities
  • To protect the confidentiality of all documents and information obtained in the audit
  • To obtain quality objectives from the manufacturer and pass them to the organisation

After completing this training, delegates will be able to implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to take on responsibilities associated with auditing authority for the management and performance of all audit activities. 

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What's included in this ISO 13485 Training Course?

This training course includes:

  • The ISO 13485 Lead Auditor Examination
  • The Knowledge Academy ISO 13485 Lead Auditor Manual 
  • Certificate
  • Experienced ISO Instructor 
  • Refreshments 

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ISO 13485 Lead Auditor Exam

In order to complete this ISO 13485 Lead Auditor training course, delegates will need to pass the associated examination. The exam is:

  • Multiple choice questions
  • Duration of 40 minutes
  • 50% pass mark
  • Closed book

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Why choose us

Ways to take this course

Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.

Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.

What our customers are saying

ISO 13485 Lead Auditor FAQs

FAQ's

ISO 13485 defines the quality management system requirements for organisations that must consistently demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements.
ISO 13485 is essential for a company to improve its credibility, create a culture of continual improvement, improve decision-making, improve employee engagement, and improve customer satisfaction.
This course is designed for everyone who wishes to advance their knowledge of implementing quality management systems for medical devices and managing auditing to improve the overall performance of an organisation.
Auditing assesses and determines if an organisation's operational, financial, and strategic goals and processes follow the stated principles.
The lead auditor is responsible for preparing audit reports, conducting interviews with company employees, reviewing company policies, and performing tests of controls.
In this ISO 13485 Lead Auditor Training course, you will learn about principles of quality management, documented procedure, evaluating and investigating nonconformities, risk mapping, monitoring and measuring product success, and other essential topics.
The price for ISO 13485 Lead Auditor certification in Canada starts from CAD2795
The Knowledge Academy is the Leading global training provider in the world for ISO 13485 Lead Auditor.

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Resources are included for a comprehensive learning experience.

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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

Joshua Davies, Thames Water

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