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

  • 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
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Who should attend this ISO 13485 Internal Auditor Course?

The ISO 13485 Internal Auditor Course is a programme that allows professionals to conduct ISO 13485-based medical device Quality Management System (QMS) Internal Audits. This course can be beneficial for professionals, including:

  • Quality Managers
  • Engineers
  • Technicians
  • Regulatory Affairs Professionals
  • Manufacturing Managers
  • Compliance Officers
  • Medical Device Consultants

Prerequisites of the ISO 13485 Internal Auditor Course

There are no formal prerequisites for this course.

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 includes an independent and systematic process audit to determine QMS's conformity or nonconformity.

This training session will provide delegates with auditing techniques for Quality Management Systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will quickly get higher designations and expand their professional networks. Professionals in roles such as Quality Managers, Regulatory Affairs Specialists, Quality Control Officers, and individuals involved in internal quality audits in the medical device industry should aim to master the ISO 13485 Internal Auditor Training Course.

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. They will also learn about management's responsibilities for making policy and financial decisions to support QMS, how to plan a medical device, quality process audit, and documentation requirements.

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 can 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 Internal Auditor Course?

  • ISO 13485 Internal Auditor Examination
  • World-Class Training Sessions from Experienced Instructors 
  • ISO 13485 Internal 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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Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Internal 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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Take part in scheduled, instructor-led sessions with real-time feedback, while enjoying the freedom to study independently. Interactive resources and progress tracking tools help you stay motivated and on target.

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Join dynamic live sessions featuring discussions, practical activities, and peer collaboration. Learn from ISO 13485 Internal Auditor industry experts and reinforce your knowledge with self-paced modules—plus, connect with professionals in your field.

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Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Internal 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 Internal Auditor sessions.

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Package deals for ISO 13485 Internal Auditor

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

ISO 13485 Internal Auditor FAQs

What is the ISO 13485 Internal Auditor Training?

ISO 13485 Internal Auditor Training equips delegates with skills to audit medical device quality management systems, ensuring compliance with ISO 13485 standards. It focuses on auditing techniques, process improvement, and regulatory requirements for the medical device industry.

Who should attend this course?

This course is ideal for Quality Managers, Internal Auditors, Regulatory Compliance Professionals, and anyone involved in implementing or auditing ISO 13485 systems within medical device organisations.

Are there any prerequisites for this course?

There are no formal prerequisites for this ISO 13485 Internal Auditor Course.

What is included in this ISO 13485 Internal Auditor Training?

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.

What is the duration of this course?

This course takes 2-day to complete during which delegates participate in intensive learning sessions that cover various course topics.

What are the benefits of this course?

Delegates gain expertise in auditing ISO 13485 systems, improve organisational compliance, enhance product quality, and boost career opportunities in the medical device industry.

Do you offer 24/7 support for the ISO 13485 Internal Auditor Training?

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 self-paced ISO 13485 Internal Auditor 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 is the scope of the ISO 13485 Internal Auditor Certification?

The certification validates your ability to conduct ISO 13485 audits, ensuring regulatory compliance and supporting global market access for medical devices.

Do you provide exam for this course?

No, there is no formal exam at the end of this course. However, delegates are assessed through practical exercises and activities throughout the training to ensure they understand and can apply the concepts effectively.

What are the topics covered in the ISO 13485 Internal Auditor Training?

Key topics include ISO 13485 requirements, audit planning, conducting and reporting audits, risk management, and process improvement in medical device quality systems.

What skills are gained from the ISO 13485 Internal Auditor Training Course?

Delegates develop skills in auditing techniques, non-conformance reporting, risk assessment, and ensuring compliance with ISO 13485 standards for medical device quality management systems.

What career opportunities can I avail myself from this ISO 13485 Internal Auditor Certification?

Completing the ISO 13485 Internal Auditor Certification can lead to roles such as Internal Auditor, Quality Assurance Specialist, Compliance Officer, and Regulatory Affairs Specialist in industries like medical devices, healthcare, and pharmaceuticals, ensuring adherence to quality management standards.

What will I learn in this ISO 13485 Internal Auditor Training Course?

You will learn to interpret ISO 13485 standards, plan and execute audits, identify risks, and recommend improvements to enhance quality management systems.

Will I receive a certification after completing this ISO 13485 Internal Auditor Training?

Yes, after completing this course you will receive a certificate of completion to validate your achievement and demonstrate your proficiency in the course material.

Why choose The Knowledge Academy in the United Kingdom over others?

The Knowledge Academy in the United Kingdom stands out as a prestigious training provider known for its extensive course offerings, expert instructors, adaptable learning formats, and industry recognition. It's a dependable option for those seeking this course.

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

The training fees for ISO 13485 Internal Auditorin the United Kingdom starts from £1795

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

The Knowledge Academy is the Leading global training provider for ISO 13485 Internal 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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