Online ISO 13485 Internal Auditor Training | CQI & IRCA Certified

Online ISO 13485 Internal Auditor Training | CQI & IRCA Certified

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Upcoming Dates
10th October 2022
24th October 2022 Enroll Now
5th December 2022 Enroll Now
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CQI IRCA
Online ISO 13485 Internal Auditor Training | CQI & IRCA Certified
  • Module 1 - Introduction to ISO 13485
    • 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
  • Overview

    Our Online ISO 13485 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 and it can be completed anytime, anywhere (24/7).

  • Blended Course Format

    This course is split into a blend of 6hrs of eLearning modules that are completed first before attending a 1-day skills-based Live Instructor Workshop.

  • 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
    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

    CQI & IRCA certified Online ISO 13485 Internal Auditor Training Course (No. 2286). Successful completion will entitle each Learner to receive a digital Certificate of Completion.

  • Assessment Methodology

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

    • Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for
    • Fully attend the Live Instructor Workshop as 100% attendance is required
    • Obtain 70% or higher in the graded assessments during the Live Instructor Workshop
  • Recommended Prior Learning

    Before completing this course, each Learner should have the following prior knowledge:

    Work Experience

    • It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 13485)

    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.

    ISO 13485 Requirements

    • Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions

    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.
  • ISO 13485 2016

    It is recommended that each Learner should have a copy of ISO 13485:2016 (International 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

    There are recommended requirements for each Learner in wishing to complete any of our eLearning 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.

    Click here to read the full technology requirements.

Live Instructor Dates
Days
Location
Course Hours
Fee
Enroll
October 202210th
1
Virtual (Zoom)
24
€ 595.00
October 202224th
1
Virtual (Zoom)
24
€ 595.00
December 20225th
1
Virtual (Zoom)
24
€ 595.00
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