- Lead Auditor Module 1 - Introduction to Quality Management Systems (eLearning)
- Purpose, Benefits & Structure of ISO 13485
- Quality Management Principles
- Terms & Definitions
- Documentation Requirements
- Lead Auditor Module 2 - Key Concepts of ISO 13485:2016 (eLearning)
- Plan-Do-Check-Act (PDCA)
- Process-based Quality Management Systems
- Risk Based Thinking (RBT)
- Management Commitment
- Lead Auditor Module 3 - Introduction to QMS Auditing (eLearning)
- Management System Audits
- Audit Terminology
- Principles of Auditing
- Audit Program Management
- Certification Audit Program
- Audit Life Cycle
- Lead Auditor Module 4 - Planning the Audit (eLearning)
- Audit Scope, Objectives & Criteria
- Selection of Audit Location
- Selection of Audit Team
- Auditee, Observer & Guides
- Lead Auditor Module 5 - Audit Initiation and Preparation (eLearning)
- Audit Initiation & Preparation
- The Audit Plan
- Audit Documentation
- Lead Auditor Module 6 - Conducting the Audit (eLearning)
- Overview of Audit Activities
- Opening Meeting
- Collecting & Verifying Information
- Lead Auditor Module 7 - Generating Audit Findings and Closing Meeting (eLearning)
- Audit Findings
- Final Audit Team Meeting
- Audit Conclusion
- Closing Meeting
- Lead Auditor Module 8 - Audit Reporting, Completion, and Follow-Up (eLearning)
- Audit Report
- Audit Completion
- Audit Follow-Up
- Lead Auditor Module 9 - Course Introduction [Live Workshop]
- Live Workshop Introduction
- Agenda, Assessment Methodology
- How You Will Learn
- Lead Auditor Module 10 - Planning the Audit [Live Workshop]
- Initial Certification Audit
- Audit Methods
- QMS Document Review
- Development of the Audit Plan & Checklist
- Lead Auditor Module 11 - Conducting the Audit [Live Workshop]
- Opening Meeting
- Simulated Audit Exercises
- Lead Auditor Module 12 - Generating Audit Findings and Closing Meeting [Live Workshop]
- Audit Findings
- Audit Conclusion
- Closing Meeting
- Lead Auditor Module 13 - Audit Report and Follow Up Activities [Live Workshop]
- Audit Report
- Audit Follow Up
Our Online ISO 13485 Lead Auditor Training Course 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
Blended Course Format
This course is split into a blend of 16hrs of eLearning that is completed first before attending 4-days (virtual) of skills-based Live Instructor Workshops.
On public courses, the live instructor workshops will run virtually from 9am – 4.30pm Eastern Standard Time (across 4 days).
On successful completion of this course, 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
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
- There is a requirement of 100% attendance to fully attend the Live Instructor Workshops
- Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
- Complete a 2hr Final Examination* that is remotely invigilated (Live Proctored). Each Learner must obtain 70% or higher in the Final Examination (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.
Recommended Prior Learning
Before completing this course, each Learner should have the following prior knowledge:
- 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
- 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 Training Requirements
- Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
- Knowledge of the requirements is a key prerequisite in attending this course as, without a good understanding, the course & final examination may be very challenging.
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.
Note: The Learner’s understanding of the prior knowledge requirements will be tested as part of the course’s continuous assessment & final examination.
ISO 13485 2016
- Each participant should bring a printed (hard) copy of the standard with them to the course. This is not provided by Comply Guru.
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.
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