ISO 13485:2016 Lead Auditor Certification Training Course – CQI & IRCA Certified

Course Overview Who is this course for?

This CQI & IRCA Certified ISO 13485:2016 Lead Auditor Training Course [Quality Management Systems Auditor/Lead Auditor incorporating the requirements of ISO 13485:2016 Training Course) is based on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a complete QMS based on ISO 13485 requirements with specific emphasis of 2nd Party auditing [Customer/Supplier audits] and 3rd Party auditing  [Certification Bodies].

During the delivery, the Learner will complete a Consultant facilitated complete systematic audit of a QMS [Medical Devices]. 

Key Course Learning Outcome Why this course is unique?

With an additional 5 hours of learning compared to our competitors, we cover new and additional topics in more depth. We focus on auditing that provides Assurance that the Quality Management System meets the needs of the interested parties & our Learners are equipped to make  higher quality insights for improved organizational performance.

Course Basics What is essential to know about this course?

  • This is a 5-day (40hr) learning event.
  • Start/Finish Times: 08:00am – 18:00pm (each day) with an earlier finish on the final day at 2pm
  • Prior Learning Requirement: Learners are required to be familiar with ISO 13485:2016 Requirements or have completed a recognised QMS Fundamentals course based on ISO 13485:2016 prior to registering for this course.

Upcoming Dates and Locations Where can I register?

We are sorry but there are currently no public training dates available for this course at the moment! If you would like to send us your details, we will contact you when a course becomes available near you. If you have any questions about this course, call (312) 496 6607.

Where are you looking to attend this training?

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Course Learning Topics What does the course cover?
  • Introduction to Auditing

    • Audit Terminology, Principles, QMS Audits
    • Auditor Code of Ethics
    • Management of an Audit Program
    • Audit Terminology, Principles, QMS Audits
    • Audit Life Cycle (On-site & Off-site Audit Activities)
    • Auditor/Auditee Roles, Responsibilities*
    • Desired Auditor Behaviours**

    Introduction to QMS Auditing

    • Process Terminology*
    • Process Models/Methodology & Categories*
    • Evaluation of the effectiveness of a Process*
    • Processes and the application of PDCA and Risk*
    • The QMS Certification Cycle & 3rd Party Certification**
    • Special Conformity Audits**

    Compliance Auditing & Methodology**

    • Medical Device Life Cycle & the Regulatory Audit Perspective**
    • Overview of Different Regulatory Requirements [EU, U.S, Japan, Canada & More]**
  • Audit Planning

    • Initiating & Preparing for the Audit
    • Audit Trails Purpose and benefits for establishing initial contact and forms of contact
    • Case Study: Document Review
    • Audit Plan
    • Audit Checklist/Audit Protocol

    Opening Meeting

    • Purpose, process and benefit of an Opening Meeting
    • Case Study – Opening Meeting

    Onsite Activities

    • Lead Auditor Leadership and Supervision**
    • Responsibilities of the Lead Auditor
    • Communication throughout the Audit Life Cycle
    • Monitoring Audit Progress
    • Consensus and Resolution Conflicts
    • Audit Reporting
    • Audit Follow-Up
    • Auditor/Technical Expert Coaching, Mentoring and Evaluation**
    • Collecting and Verifying Information
    • Introduction to Audit Findings
  • Audit Reporting

    • Audit Findings
    • Case Study: Writing Audit Findings
    • Case Study: Writing the Audit Report**

    Completing the Audit

    • Evaluating Correction & Corrective Action including Root Cause Analysis and Audit Finding Closure
    • Audit Follow Up Strategies
    • Final Audit Team Meeting
    • Closing/Exit Meeting & Role Play

Course Certification CQI & IRCA Certified Course (A18242)

This course is fully recognized by CQI & IRCA.

Additional Course Information

Business Benefits

The Kelmac Group® innovation strategy is to provide the Learner with both interactive and application based on real situations. We will approach learning to be immediately applied in any specific field or industry after our program completion. 

The Kelmac Group® focuses on accelerated learning methodologies where learner internalizes more than 90% of the complete process.  We ensure that all our accredited/certified programs are both learner centered and application based.

During this learning event we fully cover the learning requirements outlined by IRCA. The Kelmac Group® QMS Auditor/Lead Auditor (for the Medical Devices Industry) course is an Advanced QMS Auditor/Lead Auditor (for the Medical Devices Industry) Course, where we cover the IRCA QMS Auditor/Lead Auditor course criteria in more depth and we also cover additional audit topics, namely Auditor behaviors; different audit protocols other than checklists for collecting and verifying information and data; managing cultural differences, auditing top management; Auditor performance and the role of the Lead Auditor, Lead Auditor Leadership and Special Audits.

Who Should Attend?
  • Individuals interested in conducting second- or third-party audits of QMS management systems based on ISO 13485
  • Quality Management Representatives
  • Quality Consultants
  • Supplier Quality Engineers
  • Supply Chain Personnel
  • Regulatory Affairs Managers
  • Quality and Production Directors/VPs
  • Cross-functional team members of a QMS implementation project
  • Individuals who want to become an IRCA Certified Provisional Auditor, Auditor, Principal Auditor, or Lead Auditor
Course Pre-Requisites

Before starting this course, Learners are expected to have the following prior knowledge:

– Knowledge of the following quality management principles and concepts:

  • The Plan, Do, Check, Act (PDCA) cycle.
  • The relationship between quality management and customer satisfaction.
  • Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000.
  • The process approach used in quality management.
  • The Model of a Process Based Quality Management System, the structure and content of ISO 13485:2016

Important: Good working knowledge of the requirements of ISO 13485:2016 is required, which may be gained by completing an IRCA certified QMS (Medical Devices) Foundation Training course or equivalent.

Additionally- each Learner will be required to have their own copy of ISO 13485:2016 for use during the training.

Course Assessment

Each Learner is assessed during the on-site class based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course.

PLEASE NOTE: Full attendance is required during the training course.

Post the on-site class. There is a two-hour written auditor examination at the end of the on-site class. The written auditor examination is based on QMS, or ISO 13485. The written examination is closed book; however, the Learner is required to have a hard-copy version of the relevant management system standard (ISO 13485) for class use. The minimum pass rate for each written auditor examination is 70%.

Our Course vs. Our Competitors Why is our course the best? Just some examples explained of how our course goes further

Working with a Case Study: Almost Full Documented QMS for Medical Devices Why is this important?

Each Learner will audit the almost full documented QMS [MD] from the unique Kelmac Group® assurance perspective.

The Kelmac Group® assurance perspective is unique as we audit like many professional financial audit practices where the focus is on providing top management with the quality of insight to make decisions and actions aimed at improving performance of the organization.

We boast the most comprehensive documented QMS Case Study [Medical Devices] available in the market and provides the Learner with the mostrealistic practical audit experience available on the market including a ISO 13485 Quality Manual; 13 SIPOC processes [Value chain, Support and Management]; 19 procedures; and related documented templates and records.

Evaluating Business Processes Why is this important?

An important USP of this Kelmac Group course is that we show each Learner how to evaluate business processes, not just ISO processes and align with the strategic intent of the organization. Business Processes include Marketing & Sales, Design Control, Manufacturing, Logistics, Installation, Purchasing, Servicing & HR. We cover this practically and from the QMS [MD] Auditor Perspective.

Live Audit Vs. Facilitated Audit Which is better? Why?

Some competitors offer a “live” audit as part of their training. However a “live audit” of such short duration (<0.5 day typically) is of limited value as the Learner does not get an opportunity to audit an almost fully documented QMS [Medical Devices].

Kelmac Group’s course includes a “facilitated” audit which enables us to truly verify the Learner’s core audit skills through working with an almost fully documented Quality Management System [Medical Devices].

Ready to stand out from the crowd?