Online ISO 13485:2016 Internal Auditor Training | Exemplar Global Certified

★★★★★

  • Course Area:

    Medical Devices

  • Continuing Education Units (CEUs):

    1.6

  • Course Duration:

    16 Hours

  • Accreditation:

    CQI and IRCA approved training partner
  • Format:

    Online & Self-Paced Course

  • Individual Pricing:

    1195.00 per person

  • Team Pricing:

    5075.00 (5-Pack)

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Finally, an industry-leading online & blended training solution for ISO Standards, Quality Auditing & Medical Device Training!

Comply Guru LLC, based in Chicago, IL, offers a growing portfolio online & blended training courses on various ISO Standards, Quality Auditing and Medical Device Regulations to enable its Learners to get the knowledge and skills they need from home, work or anywhere!

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This Exemplar Global Certified Online (Self-Paced) ISO 13485:2016 Internal Auditor Training Course  is ideal for anyone that wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS based on ISO 13485:2016.

Learning Objectives

  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
  4. With reference to the PDCA cycle, explain the process based QMS Model for ISO 13485:2016 and the role of an internal auditor in the maintenance and improvement of Quality Management Systems
  5. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up an internal audit in accordance with ISO 19011:2018

Course Certification

This course is  Exemplar Global Certified. Successful completion will entitle each Learner to receive a digital Exemplar Global Recognized Certificate of Completion.

Assessment Methodology

In order to successfully complete this self-paced course, each Learner will need to:

  • 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)
  • Module 1 - Introduction to ISO 13485:2016

    • 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

    • QMS Processes
    • QMS Documentation
    • Document Control
    • Record Control

  • Module 3 - Management Responsibility

    • Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control),
    • Responsibility
    • Authority and Communication
    • Management Review

  • Module 4 - Resource Management

    • Resource Planning
    • Human Resources
    • Infrastructure
    • Work Environment and Contamination Control

  • Module 5 - Product Realization, Part 1

    • Planning of Product Realization & ISO 14971
    • Customer related Processes
    • Design & Development

  • Module 6 - Product Realization, Part 2

    • Purchasing
    • Production & Service Provision
    • Control of Monitoring & Measuring Equipment

  • Module 7 - Measurement, Analysis and Improvement

    • Monitoring & Measurement (feedback, complaint handling, regulatory reporting & internal audit, process and product monitoring & measuring)
    • Control of Non-Conforming Product
    • Analysis of Data
    • Improvement (CAPA)

  • Module 8 - Introduction to QMS Auditing

    • Internal Audit Requirements
    • Introduction to ISO 19011:2018
    • Onsite & Remote Audits
    • Principles of Auditing
    • Audit Lifecycle
    • Auditor Roles & Responsibilities
    • Desired Auditor Behaviour

  • Module 9 - Audit Initiation and Preparation

    • Audit Planning
    • Audit Scope, Objectives and Criteria
    • Initiating the Audit
    • Selection of Audit Team
    • Document Review
    • Preparing Audit Activities
    • Internal Audit Plan
    • Audit Checklist

  • Module 10 - Conducting Audit Activities

    • Audit Activities Workflow
    • Conducting the Audit
    • Opening Meeting
    • Communication during an Audit
    • Collecting & Verifying Information
    • Generating Audit Findings
    • Non-Conformity Grading

  • Module 11 - Audit Report, Close and Following Up the Audit

    • Non-Conformity Reporting
    • Closing Meeting
    • Audit Report & Distribution
    • Completing the Audit
    • Audit Follow Up Activities

    Course Entry Criteria

    Before completing this course, each Learner should note the following entry criteria:

    Fluency in spoken and written English

    • For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.

    Printed Copy of ISO 13485:2016

    • Each participant requires a copy of this standard for the course. This is not provided by Comply Guru and without it, this course will be extremely challenging to complete.

    E-Learning System 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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