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Online & Self-Paced ISO 13485:2016 Foundation Course (CQI & IRCA Certified)

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  • Course Area:

    Medical Devices

  • Course Duration:

    8 Hours

  • Format:

    Online & Self-Paced Course

  • Accreditation:

    CQI and IRCA approved training partner

  • Individual Pricing:

    395 per person

  • Team Pricing:

    Need more! Call us

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A video about Comply Guru's online training library for compliance and certification

On-Demand ISO 13485:2016 Foundation Training

In this video, an overview of our new On-Demand ISO 13485:2016 Foundation Training Course is provided, including what is covered on the course, who the course is for, how you will be assessed, and a preview of How You Will Learn with Comply Guru. Check it out!

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Course Overview Content Breakdown Entry & Technology Requirements

This CQI & IRCA Certified fully Online (Self-Paced) ISO 13485:2016 Foundation Training 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.

Learning Objectives

On completion, successful Learners will have the knowledge needed to:

  1. Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
  2. Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
  3. Explain the specific quality management related requirements of ISO 13485

Course Certification

This course is CQI & IRCA Certified (No. 2327). Successful completion will entitle each Learner to receive a digital CQI & IRCA Recognized Certificate of Completion.

Assessment Methodology

In order to successfully complete this online course, each Learner will need to:

  • Complete the online course modules and obtain 70% or higher in the final assessment (MCQ-based)

Course Access & Support

Upon registering for this course, a Learner will be able to avail of the following:

  • Course Access for 90-days
  • Phone & Email Support (Virtual Instructor)
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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),
    • Responsibility
    • Authority and Communication
    • Management Review

  • Module 4 - Resource Management (Online & Self-Paced)

    • Resource Planning
    • Human Resources
    • Infrastructure
    • 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)

    • Purchasing
    • 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)

Course Entry Requirements

Each Learner should 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.

Quality Management

  • 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.

Technology Requirements

The 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 Systems

Windows 7/10, Mac OSX Sierra, iPad IOS10

Mobile Devices

Comply 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 Speed

We 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
Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge are not recommended as its not compatible with the LMS and the course functionality will not work properly.

Recommended Settings

We recommend that the following settings are enabled:
  • Cookies
  • Pop-ups (in both Internet Browser and security software)
  • JavaScript
  • Plugins
  • Latest Version of Adobe Flash Player
  • Latest Version of Adobe Acrobat Reader
To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.
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