Course benefits:

Improve your knowledge of auditing techniques

Learn how to lead audit teams

Add new skills to your resume and expand your business
This ISO 13485 Lead Auditor training is accredited by ASIC and allows you to become a certification auditor for ISO 13485. The course was created to help you start working for certification bodies or expand your consulting
After passing the exam, you will receive an ISO 13485 Lead Auditor certificate, accredited by ASIC, which proves your ability to perform certification audits and lead audit teams.

The ISO 13485 Lead Auditor course is divided into three parts:

A video library: includes lessons and practical information about the standard and how to prepare for the ISO 13485 audit, lead the audit team, perform the audit and prepare the final audit report

An interactive workshop: helps you practice the concepts necessary for auditing the standard guided by an Advisera top expert

ISO 13485 Lead Auditor 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:

Novice consultants/auditors seeking to acquire new expertise and perform medical device QMS certification audits

Experienced consultants/auditors needing proof of their competence as ISO 13485 lead auditor

Quality managers that need to prepare for a medical device QMS audit

Prerequisites:

There are no prerequisites to attend the ISO 13485 Lead 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 - Auditing Basics

Introduction & suggested reading

Auditor assumptions

Techniques for finding evidence

Sampling the records

Interviewing techniques

The audit findings

Nonconformities

Observations

Internal vs. external audit

Annual audit program

Audit plan for an individual audit

Creation of the checklist

Internal audit report

Corrective action requests and corrective action follow-up

Recording the evidence

Recap quiz

Module 7 - Understanding Auditing Standards

Introduction & suggested reading

What is certification?

Certification process

Certification of integrated management systems

Introduction to accreditation and ISO 17021

Competences of lead auditors required by ISO 17021-1

Introduction to International Accreditation Forum (IAF) documents

Introduction to ISO 19011

Principles of auditing

Recap quiz

Module 8 - Understanding Audit Roles and Responsibilities

Introduction & suggested reading

Audit Team Leader / Lead Auditor

Auditor

Technical Specialist

Certification Reviewer

Audit Client

Management Team

Auditee

Hosts / Guides

Recap quiz

Module 9 - Planning the Audits

Introduction & suggested reading

Audit criteria and objectives

Audit scope

Selecting audit methods

Sampling evidence in audits

Types of remote auditing techniques

Deciding when to use remote auditing techniques

Planning the use of remote auditing techniques

Selecting the audit team

Managing audit risks

Preparing the audit plan

Allocating audit activities to auditors

Making contact with the audit client

Preparation of audit resources

Recap quiz

Module 10 - Managing the Audit Process

Introduction & suggested reading

Opening meeting

Managing site visits

Interviews

Audit evidence requests

Debriefing sessions

Dealing with conflicts

Related documentation

Recap quiz

Module 11 - Managing Your Audit Team

Introduction & suggested reading

The importance of managing your audit team

Communication with the team before the audit

Managing audit progress

Team meetings

Managing audit findings

Managing audit records

What to do when you hit problems

Evaluating your audit management

Recap quiz

Module 12 - Completing a Successful Audit

Introduction & suggested reading

Audit findings

How to reach audit conclusions

Planning the closing meeting

Holding an effective closing meeting

Dealing with feedback at closing meetings

Effective audit report writing

Post-audit activities, corrections, and correction actions

Certification review process

Related documentation

Recap quiz

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

Are the ISO 13485 Lead Auditor course and certificate accredited?

Yes, both the 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 three to four weeks so that you get the most benefit from them.

What is needed to access the ISO 13485 Lead 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 participate in the workshop?

To participate in the online workshop, we will send you a special link to connect to Zoom. All you need is a computer with a microphone, speakers, and web camera. We recommend that you have the web camera on during the workshop for an enhanced learning experience.

Are there prerequisites for attending the workshop?

Completion of all of the video lessons is the only prerequisite.

How do I get certified as ISO 13485 lead auditor?

It's simple:

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

Attend the workshop

Pass the online exam.

When will I receive the certificate for the course?

After watching all of the video lessons and completing the workshop, you may take the ISO 13485 Lead Auditor 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 Lead Auditor exam

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

The ISO 13485 Lead Auditor 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 certificate.

How many questions are on the exam?

There are a total of 93 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 ISO 13485 Lead Auditor 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 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 Lead 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 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.

Garry Cornell

ISO Consultant, Trainer, and Auditor

Garry Cornell has more than 25 years of global experience as a senior manager, certification auditor, and consultant, helping a wide range of businesses in their implementations of ISO 14001, ISO 45001, and ISO 50001. He has developed various courses and is the author of several books on auditing techniques and ISO 14001. He is a member of the Institute of Environmental Management and Assessment.

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Kristina Zvonar Brkic

ISO 13485 Lead 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 - Auditing Basics

Module 7 - Understanding Auditing Standards

Module 8 - Understanding Audit Roles and Responsibilities

Module 9 - Planning the Audits

Module 10 - Managing the Audit Process

Module 11 - Managing Your Audit Team

Module 12 - Completing a Successful Audit

Are the ISO 13485 Lead Auditor course and certificate accredited?

What is the deadline for attending the video lectures?

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

What do I need to know before attending the course?

How do I participate in the workshop?

Are there prerequisites for attending the workshop?

How do I get certified as ISO 13485 lead 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

Workshop and certificate

Select the date

Course Instructors

Kristina Zvonar Brkic

Carlos Pereira da Cruz

Garry Cornell

Why Advisera ISO 13485 Lead 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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