Course benefits:

Understand the basics of ISO 13485

Improve your knowledge of auditing techniques

Add new skills to your resume
This free ISO 13485 Internal Auditor course will teach you everything you need to know about ISO 13485 and how to perform an internal audit of your medical device Quality Management System (QMS). The course will help you get familiarized with all the key concepts of the medical device QMS and how to audit it, like planning of product realization, design and development, validation processes, identification and traceability, continual improvement, preparing the audit plan and audit checklist, etc.
After passing the ISO 13485 Internal Auditor exam, you will receive a certificate, accredited by ASIC, which proves your expertise in the standard, as most organizations seek out certified individuals.

This ISO 13485 Internal Auditor course is divided into two parts:

A video library: includes lessons and practical information about the basics of the standard and how to perform internal audits

Certification exam: upon successful completion of the exam, you will get a certificate and a badge for your LinkedIn profile to highlight your qualifications

Who should attend:

Medical device quality managers

Persons responsible for conducting ISO 13485 internal audits

Compliance managers

Prerequisites:

There are no prerequisites to attend this ISO 13485 Internal Auditor course.
Introduction

Introduction to the course

Module 1 - Introduction to ISO 13485

Introduction & suggested reading

What is ISO 13485:2016?

What is the QMS?

Why is ISO 13485:2016 important?

What is the structure of ISO 13485?

Key principles of quality management

Key interested parties in ISO 13485

Implementing ISO 13485 using The Plan Do Check Act Process

The ISO 13485 Project

Certification FAQs

Recap quiz

Module 2 - Management and Supporting Processes

Introduction & suggested reading

What is a process?

Top management commitment (clauses 5.1 and 5.2)

Quality Policy and objectives (clauses 5.3 and 5.4)

Roles and responsibilities (clause 5.5)

Management review (clause 5.6)

Documentation process (clauses 4.1 and 4.2)

Quality Manual (clause 4.2.2)

Medical Device File (clause 4.2.3)

Handling the QMS documentation (clause 4.2.4)

Records for the QMS (clause 4.2.5)

Importance of Resources management process (clause 6.1)

Managing human resources (clause 6.2)

Managing infrastructure resources (clause 6.3)

Managing work environment (clause 6.4.1)

Managing contamination (clause 6.4.2)

Managing monitoring and measuring equipment (clause 7.6)

Related documentation

Recap quiz

Module 3 - Product Realization Planning, Contract Review, and Design & Development

Introduction & suggested reading

Planning of Product Realization (clause 7.1)

Example of planning Product Realization

Overview of Customer-Related processes (clause 7.2.1)

Review of a contract or customer purchase order (clause 7.2.2)

Communication methods for the Customer-Related processes (clause 7.2.3)

Design and development overview (clause 7.3.1)

Planning for design and development (clause 7.3.2)

Design and development inputs (clause 7.3.3)

Design and development outputs (clause 7.3.4 and 7.3.5)

Design and development verification and validation (clause 7.3.6 and 7.3.7)

Design and development transfer to production (clause 7.3.8)

Control of design and development changes (clauses 7.3.9, 7.3.10)

Related documentation

Recap quiz

Module 4 - Purchasing, Production, and Service Provision

Introduction & suggested reading

Purchasing overview (clause 7.4)

Vendor Evaluation and performance (clause 7.4.1)

Purchasing information and verification of product (clauses 7.4.2 and 7.4.3)

Production and service provision overview (clause 7.5.1)

Qualification of your infrastructure (clauses 7.5.3 and 7.5.6)

Validation of processes (clauses 7.5.6 and 7.5.7)

Labeling and packaging (clause 7.5.11)

Cleanliness of product (clauses 7.5.2 and 7.5.5)

Identification and traceability (clauses 7.5.8 and 7.5.9)

Customer property and preservation (clauses 7.5.10 and 7.5.11)

Post-delivery processes (clauses 7.5.3 and 7.5.4)

Related documentation

Recap quiz

Module 5 - Measurement, Analysis, and Improvement

Introduction & suggested reading

Monitoring and measuring overview (clause 8.1)

Monitoring and measurement of products (clause 8.2.6)

Monitoring and measurement of processes (clause 8.2.5)

Feedback (clause 8.2.1)

Complaint handling (clause 8.2.2)

Reporting to regulatory authorities (clause 8.2.3)

Internal audits (clause 8.2.4)

Control of non-conforming product (clause 8.3)

Analysis of data (clause 8.4)

Improvement (clause 8.5.1)

Corrective actions (clause 8.5.2)

Preventive actions (clause 8.5.3)

Related documentation

Recap quiz

Module 6 - Introduction to the Internal Audit

Introduction & suggested reading

Internal vs. external audit

The main purpose of the internal audit

ISO Requirements for internal audits

Criteria for selecting the internal auditor

The audit findings

Nonconformities

Observations

Major and minor nonconformities

Related documentation

Recap quiz

Module 7 - Organizing the Internal Audit

Introduction and suggested reading

Organizing the internal audit

Internal audit procedure

Annual audit program

Audit plan for an individual audit

Related documentation

Recap quiz

Module 8 - Internal Audit Elements

Introduction and suggested reading

Internal audit elements

Document review

Creation of the checklist

Internal audit report

Corrective action requests and corrective action follow-up

Related documentation

Recap quiz

Module 9 - The Main Audit

Introduction and suggested reading

Auditor assumptions

Techniques for finding evidence

Sampling the records

Recording the evidence

Interviewing techniques

Remote audits

Auditing integrated management systems

Related documentation

Recap quiz

Instructions for taking the exam and obtaining the certificate
About the ISO 13485 Internal Auditor course

Are the ISO 13485 Internal Auditor course and certificate accredited?

Yes, both the ISO 13485 Internal Auditor course and the certificate are accredited by ASIC, an internationally renowned quality standard for schools, colleges, universities, and online learning providers. This accreditation provides additional credibility for the quality of Advisera’s courses and ensures that the certificate is globally recognized.

What is the deadline for attending the video lectures?

There is no time limit, so you can take as long as you need to watch the video lectures. We do, however, recommend that you watch them all within one to two weeks so that you get the most benefit from them.

What is needed to access the ISO 13485 Internal Auditor online training?

All you need to access the course is your PC, Mac, or mobile device; any major browser (Chrome, Firefox, Internet Explorer, Safari, etc.); and a broadband Internet connection. And, of course, enough available time to devote to the course.

What do I need to know before attending the course?

You don’t need any prior knowledge or experience in auditing – this course was designed so that a beginner to these topics will understand it.

How do I get certified as ISO 13485 Internal Auditor?

It's simple:

Watch complete videos of all of the lessons, and answer all of the practice exams.

Pass the online exam.

When will I receive the certificate for the course?

After watching all of the video lessons, you may take the certification exam. If you earn a passing score, you will be issued the certificate. Please note that during the exam, an online proctoring service will verify your identity and ensure that you take the exam without assistance. Click here to learn more about our online proctoring service.

About the ISO 13485 Internal Auditor exam

What does it take to pass the exam and earn the certificate?

The course materials (video lectures, quizzes, reading materials, practice exams, and other resources) are all you need to successfully pass the certification exam and receive your ISO 13485 Internal Auditor certificate.

How many questions are on the exam?

There are a total of 73 questions on the exam; some of them are True/False questions, while the others are multiple-choice questions, and all correctly answered questions are worth 1 mark.

How much time is allowed for the exam?

The time allowed to answer all the questions on the exam is 120 minutes. However, please reserve an additional 15 minutes of your time for a system check up before you start the exam session.

In which language is the exam?

The exam is in English.

Where will I take the examination?

The ISO 13485 Internal Auditor certification exam can be taken online, from anywhere. To make this possible, we employ an online proctoring service. Click here to learn more.

Course Instructors

ISO 13485 Internal Auditor Course - Advisera

Kristina Zvonar Brkic

ISO 13485 Expert

Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and an auditor and assessor for MDD.

Carlos Pereira da Cruz

ISO Consultant, Trainer, and Auditor

Carlos Pereira da Cruz has more than 30 years of experience working as a consultant, trainer, and auditor with ISO 9001 and ISO 14001. He is a university teacher and author of several books on strategic management, ISO 9001, and ISO 14001.

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ISO 13485 Internal Auditor Course

Introduction

Module 1 - Introduction to ISO 13485

Module 2 - Management and Supporting Processes

Module 3 - Product Realization Planning, Contract Review, and Design & Development

Module 4 - Purchasing, Production, and Service Provision

Module 5 - Measurement, Analysis, and Improvement

Module 6 - Introduction to the Internal Audit

Module 7 - Organizing the Internal Audit

Module 8 - Internal Audit Elements

Module 9 - The Main Audit

Are the ISO 13485 Internal Auditor course and certificate accredited?

What is the deadline for attending the video lectures?

What is needed to access the ISO 13485 Internal Auditor online training?

What do I need to know before attending the course?

How do I get certified as ISO 13485 Internal Auditor?

When will I receive the certificate for the course?

What does it take to pass the exam and earn the certificate?

How many questions are on the exam?

How much time is allowed for the exam?

In which language is the exam?

Where will I take the examination?

Online course

Exam and certificate

Course Instructors

Kristina Zvonar Brkic

Carlos Pereira da Cruz

Why Advisera ISO 13485 Internal Auditor Course?

Free unlimited access to the entire course

Globally recognized accreditation by ASIC

Expert support from Advisera's top experts

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ISO 13485 Lead Auditor

ISO 9001 Internal Auditor

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