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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

  • 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

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Who should attend this ISO 13485 Lead Auditor Course?

The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including:

  • Lead Auditors
  • Quality Control Managers
  • Regulatory Affairs Managers
  • Compliance Officers
  • Manufacturing Managers
  • Quality Assurance Professionals
  • Internal Auditors

Prerequisites of the ISO 13485 Lead Auditor Course

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of quality management systems, auditing techniques, and regulatory requirements, along with practical experience in medical device manufacturing, would greatly benefit the delegates.

 

ISO 13485 Lead Auditor Training Course Overview

ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations need to consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training equips learners with the skills required for implementing a quality management system for medical devices and conducting audits to ensure organisational performance.

Acquiring knowledge from this training benefits organisations by streamlining processes and reducing operational challenges. Individuals pursuing this training can enhance their expertise and capabilities, opening new career opportunities and potential income growth. Professionals in roles that are responsible for quality management systems, should aspire to master ISO 13485 Lead Auditor training.

The Knowledge Academy's 5-day ISO 13485 Lead Auditor Training Course offers a comprehensive understanding of quality management and the art of auditing systems. Delegates will delve into the implementation phases of ISO frameworks and gain expertise in gap analysis to support various clauses. They will also explore risk management, learning how to map identified risks and monitor continuous improvement.

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 Lead Auditor Course?

  • ISO 13485 Lead Auditor Examination
  • World-Class Training Sessions from Experienced Instructors 
  • ISO 13485 Lead Auditor Certificate
  • Digital Delegate Pack

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ISO 13485 Lead Auditor Exam Information

To achieve the ISO 13485 Lead Auditor, candidates will need to sit for an examination. The exam format is as follows: 

  • Question Type: Multiple Choice 
  • Total Questions: 30 
  • Total Marks: 30 Marks 
  • Pass Mark: 50%, or 15/30 Marks 
  • Duration: 40 Minutes  
  • Open Book/ Closed Book: 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.

This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.

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Highly experienced trainers

All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning experience.

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State of the art training venues

We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible

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Small class sizes

We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience

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Great value for money

Get more bang for your buck! If you find your chosen course cheaper elsewhere, we’ll match it!

This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.

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Tailored learning experience

Our courses can be adapted to meet your individual project or business requirements regardless of scope.

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Maximise your training budget

Cut unnecessary costs and focus your entire budget on what really matters, the training.

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Team building opportunity

This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.

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Monitor employees progress

Keep track of your employees’ progression and performance in your own workspace.

What our customers are saying

ISO 13485 Lead Auditor FAQs

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.
Implementing ISO 13485 in a company is essential to establish a comprehensive quality management system specifically designed for medical devices. This standard ensures adherence to regulatory requirements, enhances product safety, and promotes customer confidence, facilitating global market access for the company's medical devices.
Holding an ISO 13485 Lead Auditor Certification can significantly enhance a professional's credentials, enabling them to specialise in the medical devices industry's quality management systems. It opens doors to higher-level positions and leadership roles within quality assurance and regulatory affairs.
The Lead Auditor is responsible for preparing audit reports, conducting interviews with company employees, reviewing company policies, and performing tests of controls.
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.
After completing ISO 13485 Lead Auditor Course, individuals can explore a variety of job opportunities such as Quality Assurance Managers, Regulatory Affairs Specialists, or Compliance Officers in the medical device industry.
Yes, to achieve this certification, candidates must successfully pass an examination. This exam assesses the individual's knowledge and understanding of the ISO 13485 standard and their ability to apply it in real-world audit scenarios.
In this 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 the United Kingdom starts from £2495
The Knowledge Academy is the Leading global training provider for ISO 13485 Lead Auditor.
Please see our ISO 13485 Training courses available in the United Kingdom

Why choose us

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Many delivery methods

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High quality resources

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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