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Course Information

ISO 13485 Lead Implementer​ 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

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

Who should attend this ISO 13485 Training Course?

  • Anyone involved in defining, planning, or Lead Implementer​ an ISO 13485 based Quality Management System
  • Management representatives
  • Implementation team members

ISO 13485 Lead Implementer​ Training Course Overview

ISO 13485 establishes 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. The lead implementer of this standard is responsible for developing, implementing, maintaining, and monitoring a quality management system for medical devices and enhancing an organisation's overall performance. Studying this training allows learners to implement a quality management system for medical devices and strategies for mitigating the risk associated with them. Adding management skills for medical devices to the profile will help individuals to get high-profile jobs in globally recognised corporations and claim upgraded earnings.

This 3-day ISO 13485 Lead Implementer Training course provides delegates with a thorough understanding of managing quality and implementation of respective systems. During this training, delegates will become familiar with the auditing process for obtaining audit evidence and evaluating it objectively. They will also get acquainted with the control of nonconforming products detected through the inspection process. Our highly skilled and professional trainer with years of experience teaching ISO courses will conduct this training. 

Course Objectives

  • To evaluate the expectations and requirements of the customers
  • To improve the quality of medical devices manufactured by a company
  • To promote harmonisation of regulatory requirements for manufacturers
  • To enhance the credibility and image of a company to represent compliance
  • To engage management actively and undertake management system activities
  • To design and development consultancy for a respiratory inhaler manufacturer

At the end of 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 analyse the data and implement identified opportunities for improvement.

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What's included in this ISO 13485 Training Course?

This training course includes:

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

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ISO 13485 Lead Implementer Exam

In order to complete this ISO 13485 Lead Implementer 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.

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.


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.


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


Small class sizes

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


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.


Tailored learning experience

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


Maximise your training budget

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


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.


Monitor employees progress

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

What our customers are saying

ISO 13485 Lead Implementer 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.
There are no formal prerequisites for attending this ISO 13485 Lead Implementer Training course.
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.
A quality management system is important for understanding and meeting objectives, collecting process performance outcomes, and improving processes based on objective assessment.
Customer focus, leadership, people involvement, process approach, continual improvement, factual approach to decision-making, and mutually beneficial supplier relations are the principles of a quality management system.
In this ISO 13485 Lead Implementer Training course, you will learn about making policy and financial decisions, planning and realising a product, identifying the risk, ensuring products and services function, repair information, and other essential topics.
The price for ISO 13485 Lead Implementer certification in the United Kingdom starts from £1795
The Knowledge Academy is the Leading global training provider for ISO 13485 Lead Implementer.
Please see our ISO 13485 Training courses available in the United Kingdom

Why choose us


Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.


Many delivery methods

Flexible delivery methods are available depending on your learning style.


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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