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This ISO 13485:2016 Lead Auditor Training course teaches everything you need to know to conduct effective audits, either as a solo auditor or head of an audit team.
Learning is enhanced by live, real-time video examples that enable course participants to experience opening and closing meetings, as well as an authentic audit.
Learners will also learn how to correctly interpret ISO 13485:2016 requirements and prepare documented information, understand the principles of the PDCA cycle, and know how to assess and manage risk.
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) Lead Auditor.
ISO 13485 lead auditor 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 lectures with videos, presentations, and practical examples. Almost 200 pages of PDF handouts are provided, which learners are encouraged to retain and refer back to.
The course also provides a comprehensive set of Audit Checklists designed specifically for Quality Management Systems for Medical Devices. The set can be downloaded for future reference and used as a valuable tool when conducting internal audits.
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 an Quality Management System 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 an Quality Management System for Medical Devices (QMS 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.
Documented Information
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.
Risk Management
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.
Audit Process
This part introduces auditing techniques and includes a video tutorial that gives a practical "real-life" demonstration of an auditor conducting the opening meeting.
Audit Terms and Definitions, and Roles and Responsibilities
Terms and definitions are introduced and explained, as well as a discussion of the roles and responsibilities expected from a company's internal auditor.
Performing an Audit
This part includes a video tutorial that gives a practical "real-life" demonstration of audit questions and answers.
Nonconformities and Corrective Action
Nonconformities (also known as non-conformities or non-conformances) are the "gaps" in your QMS that don't fully comply with ISO 13485:2016 requirements. Corrective actions are actions taken to address these gaps. Keeping a record of all such nonconformities and corrective actions is a crucial part of auditing.
The lessons also include a video tutorial that gives a practical "real-life" demonstration of an auditor conducting the closing meeting.
This course is ideal for:
Graduates of this ISO 13485:2016 Lead Auditor 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.
Login credentials for course dashboard, handouts and course materials, and course certificate.
The course takes about 40 hours to complete (on-demand).
Technical support and access to an instructor are available when needed.
Buy without risk and get a full refund if you're not completely satisfied.
Access to this course is available immediately after payment for 3 months.
Works on PCs, tablets and smartphones. Windows, Mac, iOS and Android compatible.
Karen Palmer
9 March 2024
The interactive online course provided a great mix of lectures, videos, and practical examples. Plenty of handouts, though could do with better organization. The Audit ...
Daniel Bridges
19 July 2023
It's a long course! The course isn't easy. It's very involved and covers the technical aspects quite well. My advice is this: stick with the course, and ...
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Our courses include free materials and handouts you can download, keep, and refer back to.
Our self-paced learning allows you to stop and resume whenever you want and switch between any device.
(124)
USD 395.00
This Exemplar Global-certified course teaches learners the skills needed to audit their organization's ISO 13485 Quality Management System for Medical Devices. Topics include an overview of ISO 13485 and its requirements, documentation, implementation, auditing strategies and techniques, best practices and practical tips.
(44)
USD 495.00
Certified by Exemplar Global, this is an intensive, 24-hour course that details the ISO 13485:2016 standard, its benefits and requirements, and teaches the steps necessary to implement a Quality Management System for Medical Devices and achieve certification.
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