Online ISO 13485 Lead Auditor Training | CQI & IRCA Certified

eLearning Modules

• 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

• 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

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

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 printed 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.

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.

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

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.