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ISO 13485:2016 - Quality Management Systems for Medical Devices

In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.

Quality Control
Free Course
Study this free online course today and enhance your career by staying up to date with the new changes in this important ISO standard. ISO professionals are in high demand internationally especially in the medical device sector. The ISO 13485:2016 standard is the current international standard for medical devices manufacturers, suppliers and vendors to manage their Quality Management System effectively.
  • Duration

    2-3 Hours
  • Assessment

    Yes
  • Certification

    Yes
  • Responsive

    Yes

Description

Modules

Outcome

Certification

View course modules

Description

ISO 13485:2016 is the third edition of ISO 13485 standard, and it is titled "Medical devices -- Quality management systems -- Requirements for regulatory purposes". The updated standard explains the requirements for a quality management system (QMS) where an organization can demonstrate its capability to supply medical devices and associated services so that the organization can fulfill customer and relevant regulatory requirements consistently. ISO 13485:2016 can also be utilized by vendors or external parties that offer services or products, to medical device organizations.

This course begins by covering the context of the publication of this ISO standard, and reviews the various regulations, standards of earlier editions of this publication. Then the course highlights important terminology which are grouped under different titles. The course explains all the requirements of ISO 13485 including specific requirements of quality management system, management responsibilities together with resource management, requirements of product realization such as planning for the QMS, design and development of product, purchasing controls and production management etc. The course also covers the Clause - 8 of ISO 13485 standard as a separate module that explains all about measurement, analysis and improvement.

If you’re interested in ISO or regulatory affairs as a future career, or if you’re an ISO professional seeking to keep up to date with the latest ISO 13485 standard, then this clear and simple course is for you. Understanding ISO 13485:2016 is of vital importance for all professionals working in the medical device sector. So, start this free online course today and in just 3 hours you’ll be up to date with the new changes in this important ISO standard.

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Learning Outcomes

After completing this course you will be able to:


  • Compare the revision of ISO 13485:2003 to ISO 13485:2016
  • List the main clauses of the ISO 13485:2016 standard along with the requirements
  • Define important terminologies about medical devices as per ISO 13485:2016
  • Explain the purpose of other international and regulatory standards like ISO 14971 and FDA 21 CFR Part 820
  • Compare ISO 13485 with FDA 21 CFR Part 820
  • Describe how to manage the requirements about medical device files
  • Illustrate how to assimilate work environment and contamination control requirements
  • Describe how to manage the requirements about design and development

Certification

All Alison courses are free to enrol, study and complete. To successfully complete this Certificate course and become an Alison Graduate, you need to achieve 80% or higher in each course assessment. Once you have completed this Certificate course, you have the option to acquire official Certification, which is a great way to share your achievement with the world. Your Alison Certification is:

Ideal for sharing with potential employers - include it in your CV, professional social media profiles and job applications
An indication of your commitment to continuously learn, upskill and achieve high results
An incentive for you to continue empowering yourself through lifelong learning

Alison offers 3 types of Certification for completed Certificate courses:

Digital Certificate - a downloadable Certificate in PDF format, immediately available to you when you complete your purchase
Certificate - a physical version of your officially branded and security-marked Certificate, posted to you with FREE shipping
Framed Certificate - a physical version of your officially branded and security-marked Certificate in a stylish frame, posted to you with FREE shipping

All Certification is available to purchase through the Alison Shop. For more information on purchasing Alison Certification, please visit our faqs. If you decide not to purchase your Alison Certification, you can still demonstrate your achievement by sharing your Learner Record or Learner Achievement Verification, both of which are accessible from your Dashboard. For more details on our Certification pricing, please visit our Pricing Page.

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