Course 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.
Upcoming start dates
Training content
Introduction to ISO 13485:2016 (Medical Devices' QMS)
Description: This module explains the existing relevant standards and regulation for 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.
- Learning Outcomes
- Quality Management System of Medical Devices' Suppliers and Manufacturers
- ISO 13485:2016 Important Terminologies
- Publication of ISO 13485:2016 and Context of Publication
- Lesson Summary
Operations of Quality Management System (QMS)
Description: 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.
- Learning Outcomes
- Quality Management System Requirements
- Management Responsibility and Resource Management
- Product Realization – Planning to Design and Development
- Product Realization – Purchasing and Production
- Lesson Summary
Measurement, Analysis and Improvement
Description: 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.
- Learning Outcomes
- Monitoring and Measurement
- Control of Non-Conforming Product
- Analysis and Improvement
- Lesson Summary
Course assessment
- Assessment: ISO 13485:2016 - Quality Management Systems for Medical Devices - End of Course assessment
Certification / Credits
By the end of 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
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