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

On completion of this course, successful Learners will have the practical knowledge and be able to apply the techniques needed to:

• Explain the purpose of a medical device quality management system (MD QMS), of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
• Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
• Explain the specific quality management-related requirements of ISO 13485
• 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
• Explain the role and responsibilities of an auditor to plan, conduct, report, and follow up an internal audit in accordance with ISO 19011

CQI & IRCA certify this course (No. 2765). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.

Before completing this course, each Learner should have the following prior knowledge:

• An understanding of the requirements of ISO 13485 and the commonly used quality management terms and definitions, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Requirements / Foundation (FD132) course or equivalent.
• 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.
• The fundamental concepts and the seven quality management principles (see ISO 9000).
• The relationship between quality management, regulatory authority, and customer requirements.
• The ISO 19011 audit process.
• Regulatory authority requirements not directly covered in ISO 13485.

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) by the required deadline set in advance of the given workshop dates you are registered for (applies to blended format only)
• Fully attend the Instructor Workshops as 100% attendance is required
• Obtain 70% or higher in the graded assessments during the Instructor Workshops

For the live workshops during a virtual delivery, we utilize Microsoft Teams and SharePoint.

Learners need to individually have:

• PC or MAC Computer
• Reliable Internet
• Video Webcam
• Headset or Earbuds
• Quiet Setting

In relation to the 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.