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ISO 13485 Requirements from A to Z

Format Web-based

This course helps you understand ISO 13485:2012 requirements. You’ll apply and interpret ISO 13485:2012 clause-by-clause and know what’s different about this standard from ISO 9001. The course is especially designed for auditors, supervisors, and managers in the medical device industry.

Learn about ISO 13485:2012 and ISO 9001 requirements, interpret the ISO 13485:2012 standard, and apply these requirements to your work by completing a series of lessons, illustrations, diagrams, interactive exercises and quizzes.

Access to this course is for 180 days from the date of purchase. Any assignment that is failed and retaken will incur a remarking fee.

Course Data

  • CEU Hours: 2
  • Length: 20 Hours
  • ASQ RU: 2
  • Audience: Practitioner
  • Provider: Quality WBT
Course Overview

Learning Objectives:

  • Describe how the ISO 9000 family of documents was developed.
  • Interpret ISO 9001 and ISO 13485:2012 requirements clause-by-clause.
  • Describe the conformity assessment process.
  • Analyze the quality management systems for nonconformities.
  • Explain quality management system terminology.


Medical device industry experience is helpful.

A handy Desk Reference (student textbook), QualityWBT Glossary, and other resources
More than 20 downloadable handouts such as: an ISO 13485 checklist, study tips, a before-class assessment, and after-class objective.
Online access to ISO 9000 (vocabulary standard) granted with the purchase of this course.
Certificate of Completion

Who Should Attend:

Auditors, supervisors and managers in the medical device industry


Introduction — Class Rules
Lesson 1:  Terminology and Definitions
Lesson 2: Background, History and Rationale of Quality Management
Lesson 3: Introduction to ISO 13485:2012 (including ISO 9001)
Lesson 4-13: The Contents of ISO 13485:2012 (including ISO 9001)
Lesson 14: Final assignment to be completed


Format and Features

This Web-based, self-paced training involves combinations of lessons, illustrations, diagrams, examples, supplemental handout information, forms, interactive exercises, and quizzes. A handy Desk Reference (student textbook), QualityWBT Glossary and other resources, are included in the class.

Web-based courses require a computer and Internet access. You set the pace and are responsible for your individual learning experience.

System Requirements

  • Intel Pentium processor/compatible
  • 800x600 resolution color monitor
  • 32 MB of RAM recommended
  • 28.8 KB modem okay, high speed preferred
  • A browser such as Internet Explorer, Netscape or FireFox
  • Acrobat Reader (free plug-in)
  • Flash/Shockwave Player (free plug-in)
  • Java script (on most computers)
System Requirements
Here is what you need to participate in an ASQ web-based, self-paced, or instructor-led virtual WebEx course.

Registration Email

After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.

Technical Requirements

  • Computer – PC or Macintosh
  • High-speed internet connection
  • Adobe Flash Player 10.3 or later
  • Windows: Internet Explorer 8 or later, Google Chrome (latest version), Firefox (latest version)
  • Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)
  • For instructor-led virtual WebEx courses, a speakerphone or telephone headset in a designated room or space with no distractions (preferred)

NOTE: Refer to product description for any additional system requirements.

WebEx – Virtual Course: Advance Preparation and Student Information

Join a Test Session

We strongly suggest that you join a WebEx test session in advance of your scheduled virtual training, using your preferred web browser. This can help prevent problems launching content the day your training begins.

If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.

To join a test session (meeting), click here and enter your name and email address to join. If successful, you will see a screen that says "Congratulations! Your system is now set up properly ..."

Deactivate Pop-up Blockers

You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.

Cancellation Policy
ASQ reserves the right to cancel or re-schedule courses and to change instructors. Please be advised that in the event of a course cancellation, ASQ is not responsible for airfare penalties or other travel related expenses you may incur.
  • If you need to cancel, we will refund your paid registration fee as noted below.
    • Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
    • Requests received within 5 business days of the course starting incur a $150 processing fee.
    • After the course starts, there are no refunds or transfers.
    • Registrants who fail to attend without advance notice are liable for the entire course fee.
    • If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
  • You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.

Enrollment Details

Format: Classroom
Format: Web-based

Internet-based, self-paced training modules, which may involve combinations of text, visuals, audio, interactive simulations and quizzes (see specific courses for features and tools).  These web-based courses require a computer and Internet access.

ISOMEDAZJPR Self-Paced English 180 Days List: $389 Member: $349



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