Aimed at organizations involved in the design, manufacture, storage, distribution, service, and commissioning or decommissioning of medical devices, this Foundation course introduces learners to ISO 13485:2016 and the requirements for a Quality Management System for Medical Devices (QMS for Medical Devices).
Though brief, the course is ideal for anyone whose organization is seeking to implement and maintain a QMS for Medical Devices, and get certified to ISO 13485:2016.
The ISO 13485 introductory training is online and on-demand. It can be taken anytime and on any device.
On completion of the course you will:
The online course is interactive and combines videos with lectures and audio-visual presentations. PDF handouts are provided, which learners are encouraged to retain and refer back to.
Overview of ISO 13485:2016
This first part introduces ISO 13485, explaining what it is, how it's used, and the purpose and benefits of a QMS for Medical Devices.
ISO 13485:2016 Requirements
Next, the course takes a step-by-step look at the relevant clauses in the ISO 13485 standard in order to understand what they mean and what your company needs to do to comply with them.
Clear, well-written, and non-bureaucratic documentation is an important part of a QMS for Medical Devices.
A point worth noting here is that documents are used for storing and sharing information, while records are essentially hard copies of results (such as from an audit) or evidence of activities that have been performed. And while documents get revised from to time and are generally kept up-to-date, records are static and never revised.
Steps for Implementation & Certification
The final part explains how organizations can implement an ISO 13485 QMS for Medical Devices, ensure it complies with the standard's requirements, and achieve certification.
This course is ideal for:
Graduates of this ISO 13485:2016 Foundation Training course receive a Certificate of Completion. The certificate provides evidence of successfully passing the training program.
To receive a Certificate of Completion, you need to pass the final exam. It's a multiple-choice assessment with a passing score of 60%. The exam can be re-taken unlimited times without additional charge.
Login credentials for course dashboard, handouts and course materials, and course certificate.
The course takes about 4 hours to complete (on-demand).
Technical support and access to an instructor are available when needed.
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Access to this course is available immediately after payment for 3 months.
Works on PCs, tablets and smartphones. Windows, Mac, iOS and Android compatible.
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