Online & Blended ISO 13485:2016 Lead Auditor Training (CQI & IRCA Certified)

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  • Course Area:

    Medical Devices

  • Course Duration:

    40 Hours

  • Format:

    Blended Course (16hrs Online & Self-Paced + 3-days Traditional or Virtual Classroom)

  • Accreditation:

    CQI and IRCA approved training partner
  • Upcoming Dates:

    2nd - 5th November 2021
    14th - 17th December 2021
    22nd - 25th February 2022

    View All Dates

  • Individual Pricing:

    1195 per person

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    3585.00 (Save 25%)

    *Same Dates Apply!

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This CQI & IRCA Certified Online ISO 13485:2016 Lead Auditor Training Course (via Blended Learning) is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain the knowledge and skills required to perform first, second and third-party audits of QMS against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015

Did you know? This course is delivered both online (self-paced) & in a virtual classroom with a Live Instructor. Each learner must complete an 16hr online, self-paced training course before attending a virtual classroom-based 3-day skills-based training session. The major benefit to this approach is that it offers each Learner the flexibility to learn at their own pace and reduce the overall time spent in ANY type of classroom!

Learning Objectives

On completion of the Blended ISO 13485:2016 Lead Auditor Training Course, Learners will have gained the skills required to:

  • Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 in accordance with ISO 19011 and ISO/IEC 17021, as applicable

Course Certification

This course is certified by CQI-IRCA (Course No. 2244). Successful completion will entitle each Learner to receive a digital CQI & IRCA Certificate of Achievement.

Assessment Methodology

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

  1. Complete the online & self-paced course modules and obtain 70% or higher in the final assessment (2 Online MCQ-based Assessments) by the required deadline set in advance of the given classroom dates you are registered for
  2. Fully attend the virtual classroom element as 100% attendance is required
  3. Obtain 70% or higher in the course continuous assessment during the virtual classroom modules
  4. Complete an eAssessment (Final Examination) via Remote Invigilation (meaning that it is Live Proctored). Each Learner must obtain 70% or higher in the eAssessment which is completed securely online (under strict examination conditions). This can be completed from home, work or another suitable location that meets the examination conditions.

Course Access & Support

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

  • Self-Paced Course access up to the start of the virtual delivery
  • Comprehensive Learner Manual (hard copy)
  • Phone & Email Support (Virtual Instructor)
Includes Access Logo

Included BONUS Course: ISO 13485:2016 Foundation Training

Every Learner wishing to complete Lead Auditor training is recommended to first complete our CQI & IRCA Certified Online & Self-Paced ISO 13485:2016 Foundation Course (8hrs) that focuses on providing a comprehensive understanding of Quality Management based on the ISO 13485:2016 requirements and the key prior learning topics for this course! Whether you are new to ISO 13485 or Auditing or an experienced Professional who would benefit from a Refresher, this course is strongly recommended & included for FREE with this course! PLUS, it comes with its own separate certificate! BOOM!

  • 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 Quality Management Systems (QMS) (Online & Self-Paced)

    In this module we will explore the purpose and benefits of a QMS and an overview of the ISO 13485:2016 standard will be provided.

  • Module 2 - Key Concepts of ISO 13485:2016 (Online & Self-Paced)

    In this module an introduction to the key concepts that underpin ISO 13485 including the PDCA cycle, process-based approach, risk based thinking and management commitment and the significance of these for the QMS Auditor.

  • Module 3 - Introduction to QMS Auditing (Online & Self-Paced)

    In this module an introduction to QMS auditing including coverage of the certification audit process will be provided.

  • Module 4 - Planning the Audit (Online & Self-Paced)

    In this module we will explore the initial audit planning steps including determination of the audit objectives, scope and criteria and selection of the audit team.

  • Module 5 - Audit Initiation and Preparation (Online & Self-Paced)

    In this module we will explore the activities associated with the first two phases of the audit lifecycle including establishing contact with the auditee and development of the audit plan and audit work documents.

  • Module 6 - Conducting the Audit (Online & Self-Paced)

    In this module we will explore the opening meeting, the need for effective communication and the methods available to the QMS auditor for collecting information and audit evidence.

  • Module 7 - Generating Audit Findings and Closing Meeting (Online & Self-Paced)

    In this module we will explore the process for generating the audit findings, agenda for the final audit team meeting and the closing meeting.

  • Module 8 - Audit Reporting, Completion and Follow-Up (Online & Self-Paced)

    In this module we will explore the final three phases of the audit lifecycle including coverage of the audit report, steps required to complete the audit and requirements for following-up on the audit.

  • Module 9 - Course Introduction [Classroom/Virtual Training]

    In this module, an introduction to the classroom/virtual training element of the blended course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & training delivery.

  • Module 10 - Planning the Audit [Classroom/Virtual Training]

    In this module we will explore the key steps that are required to plan the audit using a risk-based approach. We will also conduct a document review in preparation for the audit and practice the skills required to prepare the necessary documents for the audit including the audit checklist.

  • Module 11 - Conducting the Audit [Classroom/Virtual Training]

    In this module we will practice the skills required to effectively conduct an audit using a sample QMS case study. A variety of audit methods will be practiced during this session including interview, document review and data analysis.

  • Module 12 - Generating Audit Findings and Closing Meeting [Classroom/Virtual Training]

    In this module we will practice the skills required to write and grade non-conformities and determine audit conclusions. We will also practice the skills required to conduct a closing meeting

  • Module 13 - Audit Report and Follow Up Activities [Classroom/Virtual Training]

    In this module we will practice the skills required to prepare the audit report and to evaluate audit responses including differentiating between a correction and corrective action.

    Course Entry Criteria

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

    Work Experience (Recommended)

    • It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 13485) or Internal Auditing in advance of registering for this training course

    Management Systems (Recommended)

    • 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 (Required)

    • Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
    • Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course & final examination may be very challenging.

    Fluency in spoken and written English (Required)

    • 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 (Required)

    • Each participant should bring a printed clean copy of the standard with them to the course. This is not provided by Comply Guru.
    Important Note: The Learners understanding of the prior knowledge requirements will be tested as part of the course continuous assessment & final examination.

    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.

    Additional Technology Requirements for Virtual Training

    To participate in the virtual training sessions, you will need:
    • Laptop or desktop computer (Note: A tablet or mobile device is not suitable for this training)
    • Webcam – Built-in or USB plug-in
    • Speakers and a microphone – Built-in or USB plug-in. We strongly recommend a headset if you have this available
    • Internet connection – Minimum of 1.0Mbps
    Course DatesLocationCostDurationPublic CoursePrivate Course
    2nd November 2021
    3rd November 2021
    4th November 2021
    5th November 2021

    Virtual Delivery

    € 1,195
    Includes: Online ISO 13485:2016 Foundation Course
    40 Hours
    14th December 2021
    15th December 2021
    16th December 2021
    17th December 2021

    Virtual Delivery

    € 1,195
    Includes: Online ISO 13485:2016 Foundation Course
    40 Hours
    22nd February 2022
    23rd February 2022
    24th February 2022
    25th February 2022

    Virtual Delivery

    € 1,195
    Includes: Online ISO 13485:2016 Foundation Course
    40 Hours
    10th May 2022
    11th May 2022
    12th May 2022
    13th May 2022

    Virtual Delivery

    € 1,195
    Includes: Online ISO 13485:2016 Foundation Course
    40 Hours
    23rd August 2022
    24th August 2022
    25th August 2022
    26th August 2022

    Virtual Delivery

    € 1,195
    Includes: Online ISO 13485:2016 Foundation Course
    40 Hours
    11th October 2022
    12th October 2022
    13th October 2022
    14th October 2022

    Virtual Delivery

    € 1,195
    Includes: Online ISO 13485:2016 Foundation Course
    40 Hours
    6th December 2022
    7th December 2022
    8th December 2022
    9th December 2022

    Virtual Delivery

    € 1,195
    Includes: Online ISO 13485:2016 Foundation Course
    40 Hours

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