Online ISO 13485 Internal 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

Instructor Workshop Modules

• Document Review
• Development of the Audit Plan & Checklist
• Opening Meeting
• Simulated Audit Exercises
• Audit Findings
• Audit Conclusion
• Closing Meeting
• Audit Reporting
• Audit Follow Up

On completion of this Online ISO 13485 Internal Auditor Training, successful Learners will have the knowledge needed to:

1. Explain the purpose of a medical device quality management system, of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
2. Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
3. Explain the specific quality management-related requirements of ISO 13485
4. With reference to the PDCA cycle, explain the process-based QMS Model for ISO 13485 and the role of an internal auditor in the maintenance and improvement of Quality Management Systems
5. Explain the role and responsibilities of an auditor to plan, conduct, report, and follow up an internal audit in accordance with ISO 19011

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.

ISO 13485 Internal Auditor Training Assessment Methodology

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
• Fully attend the Instructor Workshop as 100% attendance is required
• Obtain 70% or higher in the graded assessments during the Instructor Workshops

ISO 13485 Internal Auditor Training Certification

CQI & IRCA accreditation is offered with our Blended Internal QMS Auditor based on ISO 13485 Training Course (No. 2286). 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.