Online ISO 13485 Lead Auditor Training #separator_sa #site_title

Online ISO 13485 Lead Auditor Training | CQI, IRCA & Exemplar Global Certified

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Online ISO 13485 Lead Auditor Training for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485 and wants to gain the knowledge and skills required to perform full system first, second and third-party audits based on ISO 13485, in accordance with ISO 19011 and ISO IEC 17021-1.

Why Choose Blended ISO 13485 Lead Auditor Training?

Learners start by completing eLearning modules on the underlying principles & theory of Quality Management and ISO 13485 Lead Auditing that provides better preparation in advance of shorter, more focused instructor workshops on the practical skills for 1st, 2nd, and 3rd party auditing.

Course Format & Content Breakdown

This ISO 13485 Lead Auditor Training Course is split into a blend of 16hrs of eLearning that is completed first before attending 3-days (in-person) or 4-days (virtual) of skills-based Live Instructor Workshops.

It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience and learning style.

eLearning Modules

During the eLearning modules, each Learner will cover the following theory & knowledge:

  • Purpose, Benefits & Structure of ISO 13485
  • Quality Management Principles
  • Terms & Definitions
  • Documentation Requirements
  • Plan-Do-Check-Act (PDCA)
  • Process-based Quality Management Systems
  • Risk Based Thinking (RBT)
  • Management Commitment
  • Management System Audits
  • Audit Terminology
  • Principles of Auditing
  • Audit Program Management
  • Certification Audit Program
  • Audit Life Cycle
  • Audit Scope, Objectives & Criteria
  • Selection of Audit Location
  • Selection of Audit Team
  • Auditee, Observer & Guides
  • Audit Initiation & Preparation
  • The Audit Plan
  • Audit Documentation
  • Overview of Audit Activities
  • Opening Meeting
  • Communication
  • Collecting & Verifying Information
  • Audit Findings
  • Final Audit Team Meeting
  • Audit Conclusion
  • Closing Meeting
  • Audit Report
  • Audit Completion
  • Audit Follow-Up

Instructor Workshop Modules

During the instructor workshops, the focus is on skills & application of the theory for:

  • QMS Document Review
  • Development of the Audit Plan & Checklist
  • Opening Meeting
  • Simulated Audit Exercises
  • Audit Findings
  • Audit Conclusion
  • Closing Meeting
  • Audit Report
  • Audit Follow Up
  • CQI & IRCA Exam Preparation

Learning Objectives

On successful completion of this Online ISO 13485 Lead Auditor Training, Learners will have gained the knowledge & 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

Entry Requirements

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 written and spoken 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.

Copy of ISO 13485 (International Standard)

  • 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 challenging to complete successfully.

Note: The Learner’s understanding of the prior knowledge requirements will be tested as part of the course’s continuous assessment & final examination.

Assessment & Certification

ISO 13485 Lead Auditor Training Assessment Methodology

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

  1. 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
  2. Fully attend the Live Instructor Workshops as 100% attendance is required
  3. Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
  4. Complete a 2hr Final Examination* that is remotely invigilated (Live Proctored). Each Learner must obtain 70% or higher in the Final Examination which is completed securely online (under strict examination conditions).

*Note: the final examination is closed book and will assess each Learner on the full course program – including knowledge of the ISO 13485 Requirements.

ISO 13485 Lead Auditor Training Certification

CQI & IRCA have certified our Blended ISO 13485 Lead Auditor Training Course (No. 2244). Successful completion will entitle each Learner to receive a digital Certificate of Achievement.

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. Read full technology requirements

Terms & Conditions

In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.

Course Summary

  • Subject Area
  • Medical Devices
  • Duration
  • 40 Hours
  • Pricing
  • $ 1895.00 per person
  • Format
  • Blended Learning A hybrid of eLearning & Instructor Workshops
  • Accreditation
  • CQI & IRCA (No. 2244), Exemplar Global
  • CQI & IRCA Exemplar Global
  • Delivery Mode
  • Available Public or In-Company
  • Explainer Video
  • Share Course

Upcoming Schedule

Live Instructor Dates
Course Hours
March 202313th, 14th, 15th, 16th
Virtual (Zoom)
9am - 4.30pm EST
$ 1895.00
May 20238th, 9th, 10th, 11th
Virtual (Zoom)
9am - 4.30pm EST
$ 1895.00
July 202317th, 18th, 19th, 20th
Virtual (Zoom)
9am - 4.30pm EST
$ 1895.00
September 202318th, 19th, 20th, 21st
Virtual (Zoom)
9am - 4.30pm EST
$ 1895.00
November 202313th, 14th, 15th, 16th
Virtual (Zoom)
9am - 4.30pm EST
$ 1895.00