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Course Information

ISO 13485 Internal Auditor 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

 

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Prerequisites

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

Audience

This course is intended for everyone who wants to enhance their knowledge of quality management systems for medical devices and auditing techniques to meet the ISO requirements. 

ISO 13485 Internal Auditor 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. An ISO 13485 audit helps to identify the present state and health of your QMS and processes. It comprises an independent and systematic process audit to determine QMS's conformity or nonconformity. This training session equips learners with the auditing techniques of quality management systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will get higher designations and expand their professional networks within a short period.  

In this 2-day ISO 13485 Internal Auditor Training course, delegates will gain comprehensive knowledge of quality management systems and how to conduct internal auditing. During this training, delegates will learn about the management's responsibilities for making policy and financial decisions to support QMS. They will also learn how to plan a medical device and quality process audit and the documentation requirements. Our highly skilled and knowledgeable instructor with years of experience teaching ISO courses will conduct this training.  

Course Objectives

  • To carry out activities in order to achieve audit objectives
  • To provide products and services to medical device organisations
  • To enhance the organisational ability and meet customer requirements
  • To identify the context of a company as well as internal and external issues
  • To create a culture of continual improvement and improve decision-making
  • To maintain records and implement quality processes within an organisation

After attending this training, delegates will be able to promote awareness of regulations and review the management to identify improvements and regulatory requirements. They will also be able to evaluate the effectiveness of the quality management system and document each test during processing. 

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What's included in this ISO 13485 Training Course?

This training course includes:

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

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ISO 13485 Internal Auditor Exam

In order to complete this ISO 13485 Internal 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.

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 Internal Auditor FAQs

FAQ's

ISO 13485 defines the quality management system requirements for organisations that must demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements consistently.
This course is intended for everyone who wants to enhance their knowledge of quality management systems for medical devices and auditing techniques to meet the ISO requirements.
A Quality Management System (QMS) is important for understanding and meeting objectives, collecting process performance outcomes, and improving processes based on objective assessment.
Internal auditing is an impartial and independent assessment of the internal controls of an organisation in order to manage risk effectively across an organisation’s risk appetite.
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.
In this ISO 13485 Internal Auditor Training course, you will learn about how to conduct an audit, maintain continuous improvement, meets the standard requirements, Plan the sequence of interviews, and other essential topics.
The price for ISO 13485 Internal Auditor certification in Philippines starts from $1495
The Knowledge Academy is the Leading global training provider in the world for ISO 13485 Internal Auditor.

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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"

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