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, regulatory requirements, and practical experience in medical device manufacturing would significantly 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 must 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 to implement a Quality Management System for medical devices and conduct audits to ensure organisational performance. Acquiring knowledge from this training benefits organisations by streamlining processes and lowering operational challenges. Delegates pursuing this training can improve their expertise and capabilities, opening new career opportunities and potential income growth. Professionals responsible for Quality Management Systems will find mastering ISO 13485 Lead Auditor Training highly advantageous.

The Knowledge Academy provides a 5-day ISO 13485 Lead Auditor Training Course that 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 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 can 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

You’ll also get access to the MyTKA Training Portal, which will be your go to hub for all your training.
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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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Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Lead Auditor Course. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

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Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Lead Auditor Course. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 13485 Lead Auditor sessions.

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Streamline large-scale training requirements with The Knowledge Academy’s In-house/Onsite ISO 13485 Lead Auditor Course at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.

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Monitor employees progress

The course know-how will help you track and evaluate your employees' progression and performance with relative ease

Package deals for ISO 13485 Lead Auditor

Our training experts have compiled a range of course packages on a variety of categories in ISO 13485 Lead Auditor, to boost your career. The packages consist of the best possible qualifications with ISO 13485 Lead Auditor, and allows you to purchase multiple courses at a discounted rate.

ISO 13485 Lead Auditor FAQs

What is ISO 13485 Lead Auditor?

An ISO 13485 Lead Auditor is a professional trained to audit and ensure compliance with ISO 13485, the international standard for medical instrument quality control systems. Completing this course equips you with the expertise to lead and manage audits effectively.

What are the reasons for implementing ISO 13485 in a company?

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.

What are the benefits of taking this ISO 13485 Lead Auditor Training?

Taking the ISO 13485 Lead Auditor Training enhances your ability to perform effective medical device quality management systems audits, ensuring compliance with global standards. It also improves your career prospects in the medical device industry.

What are the responsibilities of the Lead Auditor?

The Lead Auditor is responsible for preparing audit reports, conducting interviews with company employees, reviewing company policies, and performing tests of controls.

Who should attend these ISO 13485 Lead Auditor Training Courses?

The ISO 13485 Lead Auditor Training Course is ideal for quality professionals, regulatory personnel, and anyone involved in medical device auditing, manufacturing, or quality management systems who seek to enhance their expertise in auditing against the ISO 13485 standard.

Is there an examination for this ISO 13485 Lead Auditor Training Certification?

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.

What will I learn in this ISO 13485 Lead Auditor Training?

In the ISO 13485 Lead Auditor Training, you’ll gain expertise in auditing medical device quality management systems, understanding ISO 13485 requirements, and leading audits effectively to ensure compliance with international standards, enhancing your auditing skills in the medical sector.

What does ISO 13485 Lead Auditor Certification aim to achieve?

The ISO 13485 Lead Auditor Certification aims to equip professionals with the skills to audit and assess medical device quality management systems, ensuring they meet regulatory requirements and standards, ultimately enhancing product safety and effectiveness in the healthcare sector.

What is the difficulty level of this ISO 13485 Lead Auditor Certification Course?

The ISO 13485 Lead Auditor Certification Course is moderately challenging. It requires a solid understanding of quality management systems and medical device regulations. It demands focus and dedication but is manageable for professionals with relevant industry experience.

Are there any prerequisites to attend this ISO 13485 Lead Auditor Training?

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of Quality Management Systems, auditing techniques, regulatory requirements, and practical experience in medical device manufacturing would significantly benefit the delegates.

What is the significance of holding ISO 13485 Lead Auditor Certification?

Holding an ISO 13485 Lead Auditor Certification signifies expertise in auditing medical device quality management systems, ensuring compliance with regulatory standards. It's essential for professionals aiming to enhance their careers in the medical device industry.

What is included in this ISO 13485 Lead Auditor Training Course?

In this training course, delegates will have intensive training with our experienced instructors, a digital delegate pack consisting of important notes related to this course, and a certificate after course completion, ensuring you gain practical experience and in-depth knowledge of ISO 13485 Lead Auditor.

What is the duration of this ISO 13485 Lead Auditor Course?

This course takes 5 days to complete, during which delegates participate in intensive learning sessions that cover various course topics.

Do you offer 24/7 support for this ISO 13485 Lead Auditor Course?

Yes, The Knowledge Academy offers 24/7 support via phone & email before attending, during, and after the course. Our customer support team is available to assist and promptly resolve any issues you may encounter.

Do you provide a self-paced ISO 13485 Lead Auditor Training Course?

The Knowledge Academy provides flexible self-paced training for this course. Self-paced training is beneficial for individuals who have an independent learning style and wish to study at their own pace and convenience.

What kind of jobs can I expect based on this ISO 13485 Lead Auditor Course?

Completing the ISO 13485 Lead Auditor Course can lead to roles such as Quality Manager, Compliance Officer, or Lead Auditor in the medical device industry. In these roles, you'll ensure regulatory compliance and effective quality management systems.

Which individuals or roles require ISO 13485 Lead Auditor Certification?

The ISO 13485 Lead Auditor Certification benefits individuals in quality management, regulatory affairs, and auditing roles, especially within the medical device industry. It equips them to ensure compliance and maintain high standards in quality management systems.

Do you provide corporate training for this ISO 13485 Lead Auditor Course?

Yes, we provide corporate training for this course, tailored to fit your organisation’s requirements.

Who should I contact if I am unable to access this ISO 13485 Lead Auditor Training Course?

If you are unable to access your training course, contact the support team at The Knowledge Academy via their customer service email or phone number provided on their website for prompt assistance and resolution of your issue.

Why should I take the ISO 13485 Lead Auditor Course?

Taking the ISO 13485 Lead Auditor Course enhances your expertise in auditing medical device quality management systems, ensuring compliance with industry standards. It’s a valuable credential that boosts your career prospects in the medical device industry.

What is the qualification for this ISO 13485 Lead Auditor Training Course?

The ISO 13485 Lead Auditor Training Course requires delegates to understand the principles of ISO standards and quality management. This qualification is ideal for professionals involved in medical device manufacturing or regulatory affairs who want to enhance their auditing skills.

What should you do after this ISO 13485 Lead Auditor Training Course?

After completing the ISO 13485 Lead Auditor Training Course, you can pursue roles in quality management, lead audits in medical device industries, or enhance your current position by ensuring compliance with global standards in medical device manufacturing.

Is it necessary to have a background in other ISO 13485 Courses to take ISO 13485 Lead Auditor Training?

A background in other ISO 13485 courses is unnecessary to take ISO 13485 Lead Auditor Training, but it can be beneficial. The training covers essential auditing skills and ISO 13485 requirements, thoroughly preparing you.

What is the cost/training fees for ISO 13485 Lead Auditor in the United Kingdom?

The training fees for ISO 13485 Lead Auditorin the United Kingdom starts from £2495

Which is the best training institute/provider of ISO 13485 Lead Auditor in the United Kingdom?

The Knowledge Academy is the Leading global training provider for ISO 13485 Lead Auditor.

What are the best ISO 13485 Training courses in the United Kingdom?

Please see our ISO 13485 Training courses available in the United Kingdom

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