VIRTUAL [VILT] Combined OHSMS ISO 45001:2018 and EMS ISO 45001:2018 Lead Auditor Training Course | CQI-IRCA Certified

Course Overview Who is this course for?

Our course is aimed at Environmental and Occupational Health and Safety Professionals, Consultants, Auditors and Managers who:

  • Want to audit the Environmental Management System [EMS] against the requirements of ISO 14001:2015 and the Occupational Health and Safety Management System [OHSMS] against the requirements of ISO 45001:2018
  • Want to add to your credibility with a globally recognised and  accepted qualification
  • Want to satisfy the formal training requirements for CQI-IRCA certification

This course provides Environmental and Occupational Health and Safety Professionals, Consultants, Auditors, and Managers with the knowledge skills to perform first-party, second-party, and third-party audits of Environmental Management Systems against ISO 14001:2015 and Occupational Health and Safety Management Systems against ISO 45001:2018, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015, as applicable. 

Key Course Learning Outcome Why this course is unique?

Management Systems

  • The Plan, Do, Check, Act [PDCA] Cycle
  • The core elements of a management system and the inter-relationship between top management responsibility, policy, objectives, implementation, measurement, review and continual improvement

Environment Management

  • The intended outcomes of an Environment Management System
  • Enhancement of Environmental performance
  • Fulfilment of compliance obligations
  • Achievement of environmental objectives

ISO 14001:2015

  • Knowledge of the requirements of ISO 14001:2015 and the commonly used environmental terms and definitions, as given in ISO 14000:2015, which may be gained by completing a Kelmac Group® and  Certified EMS ISO 14001:2015 Fundamentals training course or equivalent

Occupational Health and Safety Management

  • The concepts of managing Occupational Health and Safety through hazard identification, risk assessment, risk control, and compliance with legal requirements and other requirements
  • The relationship between Occupational Health and Safety Management and the provision of safe and healthy workplaces, the prevention of work-related injury and ill health, and the proactive improvement of occupational health and safety performance
  • Common examples of relevant national and local Occupational Health and Safety legislation and requirements of ISO 45001:2018

ISO 45001:2018

  • Knowledge of the requirements of ISO 45001:2018 and the commonly used Occupational Health and Safety terms and definitions, as given in ISO 45001:2018, which may be gained by completing a Kelmac Group® and CQI-IRCA Certified ISO 45001:2018 Fundamentals [OHSMS] training course or equivalent

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call (312) 496 6607

All our courses are available onsite, click below to reference the form for an onsite training quote or call (312) 496 6607

Early Bird Discounting Available:

Register & Pay 45 days in advance and save $ 50

Register & Pay 75 days in advance and save $ 100


Discounts cannot be combined with any other offer.

Start Date Location Cost Days Public Course Onsite
17th May 2021
08 : 00 AM - 17 : 30 PM CDT
Virtual $ 2435.00
( $45.00 CQI-IRCA Certification/eCourse Material Content Fee )
5 Days
21st June 2021
08 : 00 AM - 17 : 30 PM EST
Virtual $ 2435.00
( $45.00 CQI-IRCA Certification/eCourse Material Content Fee )
5 Days

* Advance 45 Day Early Bird Discount, Terms & Conditions Apply

** Advance 75 Day Early Bird Discount, Terms & Conditions Apply

Course Learning Topics What does the course cover?
  • Our Virtual [VILT] teaches Learners the audit principles, tools and techniques used for the assessment of the performance of the organization’s Medical Device Quality Management System [QMS]. 

    The following is a breakdown of the course sessions;

    • Session 0 – Course Introduction

      Kelmac Group® Profile; Course Introduction; Structure of the Learner Manual; Learner Attendance; Course Outcome; Continuous Assessment; Course Program; Course Aims and Objectives; Introduction to CQI-IRCA; Blbliography; Terminology; ISO in Brief

    • Session 1 – Medical Device Quality Management System Overview/Refresher

      What is an QMS; Purpose/Benefits; Scope of ISO 45001; History/Evolution; ISO 45001 Family of Standards; MD QMS Terminology; Key Changes and Concepts; High Level Structure; Benefits of Certification/Registration; ISO 45001:2018 Requirement Application

    • Session 2 – Compliance Management System – How to audit compliance requirements?

      Introduction to ISO 19600:2014; Compliance Terminology; Management System Auditor versus Inspector; Establishing the Compliance Management System; Compliance Principles; Implementation and Maintenance of the Compliance Management System; Compliance Auditing for Management System Auditors

    • Session 3 – Introduction to Auditing

      Auditing Terminology; Management System Audits; Principles of Auditing; CQI-IRCA Professional Code of Practice; Audit Life Cycle; Appointment if Lead Auditor and Audit Team; Desired Auditor Behaviours; Auditr Program Management; Conformity Assessment Standard – ISO/IEC 17021-1:2015

    • Session 4 – Initiation and Preparation

      Initiation the Audit; Initial contract with the Auditee; Audit Objectives, Scope and Criteria; Audit Feasability; Preparation for the Audit; Audit Working Documents; Audit Plan; Audit Checklists; 

    • Session 5 – Conducting the Audit

      Pre-Opening Meeting Activities; Opening Meeting; Gathering Audit Evidence; Five Core Audit Methods; Auditor Note Taking; Audit Sampling; Managing the Audit Team; Audit Communications; Auditee Reactions; Audit Findings; Case Study – Simulated Audit  

    • Session 6 – Audit Reporting

      Writing/Grading Audit Findings; Audit Conclusion; Audit Report

    • Session 7 – Final Audit Team/closing-Exit Meeting

      Final Audit Team Meeting; Evaluating Correction/Corrective Action; Audit Finding Follow-up; Closing-Exit Meeting; 

      The following are the workshops completed during this class:

*Kelmac Group cover this topic in more depth compared to our competitors.
**Kelmac Group proven added value as this material is not covered by the IRCA specification or our competitors.

Course Certification CQI & IRCA Certified Course (A18114)

This course is fully recognized by CQI & IRCA.

Additional Course Information

How Will I Be Assessed?

Full or 100% attendance is required during the virtual [VILT] training course.

Continuous Assessment

The Learner is assessed during the virtual class delivery based on participation and performance throughout the duration of the virtual course. This includes all exercises, role plays, case studiy and all other activities during the virtual course.  The Learner is expected to turn their webcam on during all virtual class sessions.  The Learner may turn-off their webcam during class break times.


There are two (2) phased two-hour eAssessment auditor examinations during this learning event. The first written auditor examination is based on EMS, or ISO 14001:2015; the second is based on OHSMS, or ISO 45001:2018. Both eAssessment examinations are closed book; however, the learner is required to have a hard-copy or digital version of the relevant management system standards (ISO 14001:2015 and ISO 45001:2018) for class use. The minimum pass rate for each written auditor examination is 70%.

Who Should Attend?
  • Individuals interested in conducting second- or third-party audits of EMS and OHSAS management systems
  • Environmental and Occupational Health And Safety Management Representatives
  • Environmental or Health and Safety Consultants
  • Quality Directors
  • Regulatory Affairs managers
  • Health, safety, and environmental managers
  • Environmental or Occupational Health and Safety cross-functional team members of an environmental or occupational health and safety implementation project
Our Course vs. Our Competitors Why is our course the best? Just some examples explained of how our course goes further

  • With 50% more skill based exercises compared to our competitors. We focus on auditing that provides Assurance that the Medical Device Quality Management System meets the needs of the interested parties & our Learners are equipped to make higher quality insights for improved organizational performanceLearners practice using audit tools and techniques they can uses immediately and that inspire’s Learner confidence
  • Access to digital copy of course documentation, relevant standards following completion of course registration and up to twelve months following completion of the course
  • Our investment in our Consultant-Trainer knowledge management, learning, and digital technologies means learners are challenged and encouraged to become the very best Medical Device QMS Supplier or Lead Auditors in their respective industries 
  • Learners complete a phased Kelmac Group® and CQI-IRCA eAssessment examination compared to a traditional 2 hour written examination on the last day of the class

Others train followers, we prepare and develop MD QMS Supplier and Lead Auditors™ for the most pressing Medical Device Quality issues facing the medical device industry and society today

Basic Course Requirements

  • The Kelmac Group® is known for our in-person classrom and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our Consultant-Trainer and learners interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment. This is an ideal alternative to the typical classroom setting for professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.
  • This class is delivered over five consecutive days, 08:00 to 17:30, Monday to Friday
  • Kelmac Group’s® virtual instructor-led training (VILT) is a live web-based learning experience where the Consultant-Trainer and learners are in separate locations.
  • Kelmac Group’s® VILT technology platform is designed to ensure similar interaction as a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaging workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which learners can connect with the content and interact with both the Consultant-Trainer and other learners.
  • The learning objectives and topics covered during the VILT are the same as the corresponding in-person version of the class. That said, to accommodate a virtual setting, the pace at which the VILT is delivered, and the structure of class workshops and exercises, is modified to support engagement in a virtual format. Virtual class participants receive eBooks instead of printed materials.
  • All VILT classes are taught by the same, experienced team of Consultant-Trainers you’ve come to expect from the Kelmac Group®. Our team of VILT Consultant-Trainers are trained in virtual facilitation – ensuring a lively, interactive learning experience.
  • How do I need to participate in a VILT class. First and foremost, your enthusiasm. In addition, course learners are required to have their own PC or laptop with a high-speed internet connection. We recommend a headset with microphone, video capability, and the ability to participate in the training from a private, quiet setting. If possible, have two monitors; one for the virtual classroom and the other for viewing training materials. Dual monitors may be helpful but are not required

Virtual Training Technology Requirements


To participate in the virtual training sessions, you will need:

  • Use the latest version laptop or desktop computer. The laptop or desktop computer should not be in use for more than 4 years. (Note: A tablet or mobile device is not suitable for this training).
  • HD Webcam – Built-in or USB plug-in
  • Speakers and a microphone – Built-in or USB plug-in. We highly recommend a headset if you have this available for optimal audio quality
  • Internet connection – Minimum of 2.5Mbps download, 3.0 Mbps upload
  • Two display monitors are highly recommended
    • One for joining the virtual classroom and, if applicable, viewing digital eCourse documentation
    • The other for completing class exercises/assignments

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