Course benefits:

Understand the basics of ISO 13485

Learn the best practices for ISO 13485 compliance

Add new skills to your resume
This beginner-level course will teach you all that you need to understand the ISO 13485 standard and help you get familiarized with all the key concepts of a medical device QMS, like planning of product realization, design and development, validation processes, identification and traceability, management commitment, continual improvement, etc.
After passing the ISO 13485 Foundations exam, you will receive a certificate, accredited by ASIC, which proves your proficiency in the ISO 13485 standard.

This ISO 13485 Foundations course is divided into two parts:

A video library: includes lessons and practical information about the basics of the standard

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:

Team members involved in ISO 13485 implementation

Persons wanting to learn the basics of the ISO 13485 standard

Persons seeking to acquire new expertise and start a career in medical devices Quality Management Systems

Prerequisites:

There are no prerequisites to attend this ISO 13485 Foundations 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

Instructions for taking the exam and obtaining the certificate
Advisera’s courses are accredited by ASIC

ASIC is one of the world's largest international accreditation agencies for schools, colleges, universities, and online learning providers. Based in the UK, this government-approved quality assurance body is recognized globally, with more than 400 providers accredited in over 65 countries.

Why Advisera chose ASIC

Advisera chose ASIC accreditation because it is focused primarily on leading universities and online training organizations. When compared to other accreditation bodies, it has the largest portfolio of higher education organizations, as well as distance education providers.
About the ISO 13485 Foundations course

How do I purchase exams for several people?

We have prepared a discount if you purchase certificates for more than one student at once. Do not hesitate to contact us at sales@advisera.com to find out the prices.

Are the ISO 13485 Foundations 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 one to two weeks so that you get the most benefit from them.

What is needed to access the ISO 13485 Foundations 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 a medical device QMS – this course was designed
so that a beginner to these topics will understand it.

How do I get certified?

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 Foundations 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 Foundations certificate.

How many questions are on the exam?

There are a total of 29 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 Foundations exam is 45 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 Foundations certification exam can be taken online, from anywhere. To make this possible, we employ an online proctoring service. Click here to learn more.

Course Instructor

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.

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ISO 13485 Foundations 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

Advisera’s courses are accredited by ASIC

Why Advisera chose ASIC

How do I purchase exams for several people?

Are the ISO 13485 Foundations course and certificate accredited?

What is the deadline for attending the video lectures?

What is needed to access the ISO 13485 Foundations online training?

What do I need to know before attending the course?

How do I get certified?

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 Instructor

Kristina Zvonar Brkic

Why Advisera ISO 13485 Foundations Course?

Free unlimited access to the entire course

Globally recognized accreditation by ASIC

Expert support from Advisera's top experts

500 students have attended this course already

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