This Implementer course gives learners a detailed understanding of ISO 13485:2016 and how to achieve certification. Topics covered include the requirements of a Quality Management System for Medical Devices (QMS for Medical Devices), its benefits, documented information, implementation techniques, and preparation for the certification audit.
The course is ideal for anyone who needs a thorough understanding of ISO 13485:2016, will be playing a key role in implementing and maintaining a QMS for Medical Devices at your company, and needs to know the steps required to achieve certification.
The ISO 13485 course includes an examination. Upon successful completion, graduates have the option to seek registration as an Exemplar Global Certified Medical Device Management System (ISO 13485) Specialist.
ISO 13485 implementer training and exam are online and on-demand. Both 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, presentations, and practical examples. More than 200 pages of 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.
Principles of ISO 13485
The ISO 13485:2016 standard embraces 8 core principles: customer focus, the engagement of people (staff and managers) within the organization, strong leadership, continual improvement, evidence-based decision making, a process approach, a system approach to management, and relationship management.
Requirements of a Quality Management System for Medical Devices
This part takes a step-by-step look at the relevant clauses in the ISO 13485:2016 standard in order to understand what they mean and what your company needs to do to comply with them.
Control of Documents & Records
Clear, well-written, and non-bureaucratic documentation is an important part of a QMS for Medical Devices.
While documents are used for storing and sharing information, 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.
The ISO 13485 standard requires that risk-based thinking be a part of your Quality Management System's processes, and risk management be a key consideration with regards to patient and/or end-user safety when using a medical device.
Steps for Implementation & Certification
The final part examines the steps necessary to implement an ISO 13485 QMS for Medical Devices and achieve certification.
This course is ideal for:
Graduates of this ISO 13485:2016 Implementer Training course receive a Certificate of Completion with the Exemplar Global accreditation mark. 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.
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The course takes about 24 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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