Online ISO 13485:2016 Foundation Training
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.
If you are interested in this course, we recommend having a look at our free online ISO 13485:2016 demo course. Check it out today!
- 8hr Hours
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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 fully certified by Comply Guru™.
Successful completion will entitle each Learner to receive a certificate of completion.
What each Learner should know before completing this course:CQI & IRCA recommend that each Learner have the following prior knowledge before completing 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.
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