ISO 13485 Internal Auditor Training for Medical Device Quality Management Systems (MD-QMS)

On completion of this course, 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

A summary of learning topics within this course include:

• 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

Exemplar Global certify this course under the Recognized Training Provider scheme. Learners will receive a certificate upon completion with their logo on their digital Certificate of Completion.

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)
• 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.

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.

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)

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 the full technology requirements here.