Online & Self-Paced ISO 13485:2016 Foundation Course (CQI & IRCA Certified)
This fully online, self-paced course is ideal for anyone that wants to gain a comprehensive understanding of the requirements of ISO 13485:2016 and wants to flexibility to learn at their own pace and in their own time.
Request a free demo today to see if our training is for you!
Course Duration:8 Hours
FormatOnline & Self-Paced Course
Delivery Options & Discounts
- Online & Self-Paced Only
- Discounts Available for 10+ Licenses
- Course Access for 90 days
- Virtual Instructor Assistance – Phone & Email Support
This course is online, self-paced & available 24/7/365
CQI & IRCA Certified Course (No. 2327)
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Module 0 - Course Introduction (Online & Self-Paced)
In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.
Module 1 - Introduction to ISO 13485:2016 (Online & Self-Paced)
- Purpose, Benefits & Structure of ISO 13485:2016
- Key Terms & Definitions
- Principles of Quality Management
- Relationship with ISO 9001
- Key Revisions of ISO 13485
- Key Concepts (PDCA, Process Approach, Risk Management)
Module 2 - Establishing a QMS (Online & Self-Paced)
- QMS Processes
- QMS Documentation
- Document Control
- Record Control
Module 3 - Management Responsibility (Online & Self-Paced)
- Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control),
- Authority and Communication
- Management Review
Module 4 - Resource Management (Online & Self-Paced)
- Resource Planning
- Human Resources
- Work Environment and Contamination Control
Module 5 - Product Realization, Part 1 (Online & Self-Paced)
- Planning of Product Realization & ISO 14971
- Customer related Processes
- Design & Development
Module 6 - Product Realization, Part 2 (Online & Self-Paced)
- Production & Service Provision
- Control of Monitoring & Measuring Equipment
Module 7 - Measurement, Analysis and Improvement (Online & Self-Paced)
- Monitoring & Measurement (feedback, complaint handling, regulatory reporting & internal audit, process and product monitoring & measuring)
- Control of Non-Conforming Product
- Analysis of Data
- Improvement (CAPA)
This course is CQI & IRCA Certified (No. 2327)
Successful completion will entitle each Learner to receive a Certificate of Completion.
This course is really good. There is a perfect balance between presentations and writen content. The different knowledge checks over the course are really useful. I deeply recommend this course.
Melody Labrune | September 10, 2020
The mix of video and test presentation is very good and well balanced. The ongoing learning recheck and assessment ensures a better understanding of each section and creates a good awareness of progress.The flexibility of being able to start leave and come back is ideally suited to the busy world of work whether from home or in the office. The ongoing support and communication from Comply Guru is another plus. I would have no hesitation in recommending Comply Guru for this and other Quality Courses.
Gerry McNamara | September 9, 2020
My overall experience with Comply Guru is very good there was a huge amount of information in the course some provided by videos which made it easier to follow. I found the scenario type questions very beneficial.
Aisling Hassett | September 8, 2020
Thank you very much for the well structured guidance through ISO 13485
Gunther Burgstaller | September 7, 2020
I felt that this was a very informative training. I liked that each part of a module was short enough for you to keep focus and that there were quizzes after a part and module. I know that its difficult to speak about an ISO in an interesting way but the video speakers could have been a little more outgoing. I really enjoyed the visuals outlines and auto speaker.
Ashley Sekulich | September 7, 2020
Very pleased with this course. The design of the course is exceptional with varied training methods used throughout. this helps to break up the topic and avoid fatigue. I loved the little quizzes throughout the course. I also liked that I could click certain options to see further information- this allows the course to be tailored to the level of knowledge of the participants.
Angela O'Sullivan | September 4, 2020
The training offers essential terminology and info on ISO 13485 requirements. The unique delivery style of remote onsite instructor-led training and computer-evaluation is perfect. I would recommend the flexibility of its modular approach allowing completion of an 8 h course when in FT-employment.
Aidan Toner | September 4, 2020
Great to see a foundation course available for this topic the online format of training gives the flexibility to complete over short periods of time if necessary max 1 hour training in a module. The information given is beneficial and also given in a self intuitive style with further support available as necessary. I would definitely recommend this course.
Pauline McManus | August 31, 2020
Very helpful course great for anyone looking to increase their understanding of ISO 13485
Emma O'Brien | August 31, 2020
I completed the online ISO 13485 Foundation course. I found the delivery clear concise easy to use interesting I can say I know a lot more about the various clauses of ISO 13485 now than I did before this course. Highly recommended.
Robert Casey | August 31, 2020
I found the course very worthwhile and gives a good base knowledge of the ISO.
Tim Cully | August 20, 2020
I enjoyed the course a lot. It was well structured and easy to follow. The course provided a number of best practices and crucial activitiespoints on top of the ISO13485 requirements.
Kean Beng Ho | August 19, 2020
Overall the course was good informative and expanded my knowledge The assessmentsknowledge checks throughout the course were very helpful.
Liona Carroll Crowley | August 17, 2020
The wording was very different to the standard. I found it hard to try and match things up because they were worded differently. Not a bad thing but I found it a little time consuming matching wording.
Sarah Jane O'Farrell | August 11, 2020
As a former Quality Manager with direct reports in regulatory quality assurance and quality control I can highly recommend this excellent course. The blend of supporting on line documentation plus well thought out and delivered video clips ensures that the content is of the required standard duration and is delivered in an authoritative and informative style. The additional technical information supplied in the resource section augments the course content and provides that extra detail gat makes all the difference.
Brian O'Connell | August 11, 2020
Experience is good, and your support off line is excellent in terms of helping to resolve tech issues
Alicia Baldonedo | August 6, 2020
I really enjoyed this training and found it beneficial particularly before internal auditor training. The mix of videos, scenarios and assessments were really engaging even though the training was delivered online.
Jade Dalton | August 6, 2020
An excellent, well written course! I had very little knowledge on ISO 13485:2016 and this has now given me an excellent understanding of the standard. Being able to do the modules at your own pace, in your own time is perfect. Thanks again!
Abbie Ambridge | August 5, 2020
What each Learner should know before completing this course:CQI & IRCA recommend only that each Learner have the following prior knowledge before completing this course which would be beneficial, but it is not required in order to register for this course: Management systems
- The Plan, Do, Check, Act (PDCA) cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
- The fundamental concepts and commonly used quality management terms and definitions
Printed Copy of ISO 13485:2016
- Each participant should have a printed copy of the standard to reference while completing this course. This is not provided by Comply Guru and without it, this course will be very challenging to complete successfully.
E-Learning System RequirementsThe below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Recommended Operating SystemsWindows 7/10, Mac OSX Sierra, iPad IOS10
Mobile DevicesComply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.
Internet SpeedWe recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content
Recommended Internet Browsers
- Google Chrome 32 bit version 50 or later
- Safari 10 or later
Recommended SettingsWe recommend that the following settings are enabled:
- Pop-ups (in both Internet Browser and security software)
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader
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