ISO 13485:2016 - Quality Management Systems for Medical Devices (Free Online Course With Certificate) Alison Free Online Learning

This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies related to stakeholders, products, QMS, Risk and Sterilization, and more!

This Free Online Course Includes:

• 1.5-3 Hours of Learning
• CPD Accreditation
• Final Assessment

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ISO 13485:2016 is the third edition of the 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 fulfil 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, and standards of earlier editions of this publication. Then the course highlights important terminology which is grouped under different titles. The course explains all the requirements of ISO 13485 including specific requirements of the quality management system, management responsibilities together with resource management, requirements of product realization such as planning for the QMS, design and development of the product, purchasing controls and production management etc. The course also covers Clause - 8 of the 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.

Module 1

Introduction to ISO 13485:2016 (Medical Devices' QMS)

This module explains the existing relevant standards and regulations for the medical devices industry and enlightens the revision of ISO 13485. It also presents some important terminologies with related definitions as defined by ISO 13485; which are arranged in separate groups. It also covers the comparison of ISO 13485 to FDA 21 CFR Part 820. All mandatory documents required by different clauses of the ISO 13485:2016 standard are also enumerated in this module along with its given clause reference.

Module 2

Operations of Quality Management System (QMS)

In this module, you will learn the operations of the QMS for a medical devices company. It covers top management requirements and offers ideas to manage resource requirements in the organization. It enlightens the concept of medical devices' product realization. It covers all elements of product realization such as quality planning, customer-related processes, design and development, purchasing and production etc.

Module 3

Measurement, Analysis and Improvement

In this module, Clause - 8 of the ISO 13485:2016 standard is taught. Clause - 8 specifies the general requirements, management of monitoring and measurement issues, nonconforming product management, data analysis etc. Within this clause - 8, Clause - 8.5 is on improvement which paves out ways for the organization to improve its system, products, and processes through the framework of corrective and preventive actions.

Module 4

Course assessment

What You Will Learn In This Free Course

• 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 for medical device files.
• Illustrate how to assimilate work environment and contamination control requirements.
• Describe how to manage the requirements for design and development.

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