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Course Information

ISO 13485 Lead Implementer​ ​Course Outline

The following subjects will be taught during the ISO 13485 course:

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: A Overview of ISO 13485:2016 Requirements

  • General requirements
  • Documentation requirements
  • Management responsibility
  • Resources
  • Product realisation
  • Infrastructure
  • Risk management

Module 3: Implementation Phases of the ISO 13485 Frameworks

  • Stages to implementation
  • Gap analysis
  • Process mapping

Module 4: Conducting an ISO 13485 Certification Audit

  • Certification audits

Module 5: The Relationship Between ISO 13485 and ISO 9001

  • Scope
  • Focus
  • Continual improvement
  • Terminology
  • Differences between the standards
  • Similarities between ISO 13485 and ISO 9001

Module 6: Internal Auditing

  • Internal audit objectives
  • Auditing skills
  • Planning, preparation, and management of audits
  • Internal audit – PDCA cycle
  • Types of audit
  • Audit techniques

Module 7: The Internal Audit Plan

  • The audit plan
  • Criteria

Module 8: The Audit Process

  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings

Module 9: Internal Audit Evidence and Findings

  • Classification
  • The closing report
  • Nonconformities
  • Documented procedure

Module 10: Roles and Responsibilities

  • Internal Auditor responsibilities
  • Closing meeting
  • Management responsibilities

Module 11: Resource Management and Product Realisation

  • Provision of resources
  • Infrastructure
  • Planning and development of products

Module 12: ISO 13485 and Quality Management Systems

Module 13: Principles of Quality Management System

  • Customer and regulatory focus
  • Leadership
  • Involvement
  • The process approach
  • Common tools
  • Decision making
  • Supplier management
  • System management
  • Continuous improvement

Module 14: The Fundamentals of Quality Management Systems

Module 15: Requirements and Quality Systems

Module 16: Measurement, Analysis, and Improvement

  • Monitoring and measurement
  • Control of non-conforming products
  • The performance of the QMS
  • Analysis of data
  • Improvement of quality
  • Corrective action
  • Preventive action
  • Identification of improvement opportunities

Module 17: Risk Management

  • Risk management principles
  • The risk management process
  • Risk lifecycle
  • Risk management tools
  • Risk management culture
  • Assessments and control of risk management

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We recommend completing the ISO 13485 Foundation certification before studying this 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​ Course Overview

This ISO course has been designed to provide participants with the knowledge to effectively implement a quality management system in line with the requirements of ISO 13485. Training will also indicate how to develop quality policies, the core characteristics of risk assessments, the significance of legislation, and how to create an efficacious management review process. By attending this ISO course, trainees will gain the capability to follow their Quality Management System and subsequently enhance business performance. Furthermore, with the knowledge gained from this 3-days training course, delegates will be able to find ways to increase efficiency and cost savings through quality management, monitor supply chains to achieve continuous improvement, and meet customer and regulatory requirements.

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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


Please arrive at the venue for 08:45am
No pre- requisites are required for this course however a basic knowledge of medical devices, ISO 9001, or ISO 13485 would be beneficial.
This course is 2 days
ISO 13485 certification
Manual, Certificate, Exam, Experienced Instructor, Refreshments
Once your booking has been placed and confirmed, you will receive an email which contains your course location, course overview, pre-course reading material (if required), course agenda and payment receipts
The price for ISO 13485 Lead Implementer certification in the United Kingdom starts from £1795
The Knowledge Academy is the Leading global training provider in the world 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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