Online ISO 13485 Foundation Training | CQI, IRCA & Exemplar Global Certified

eLearning Modules

• Purpose, Benefits & Structure of ISO 13485
• Key Terms & Definitions
• Principles of Quality Management
• Relationship with ISO 9001
• Key Concepts (PDCA, Process Approach, Risk Management)
• QMS Processes
• QMS Documentation
• Document Control
• Record Control
• Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control)
• Responsibility
• Authority and Communication
• Management Review
• Resource Planning
• Human Resources
• Infrastructure
• Work Environment and Contamination Control
• Planning of Product Realization & ISO 14971
• Customer related Processes
• Design & Development
• Purchasing
• Production & Service Provision
• Control of Monitoring & Measuring Equipment
• Monitoring & Measurement (feedback, complaint handling, regulatory reporting & internal audit, process and product monitoring & measuring)
• Control of Non-Conforming Product
• Analysis of Data
• Improvement (CAPA)

On completion of this Online ISO 13485 Foundation 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

It is recommended that each Learner should have the following prior knowledge before completing this course:

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.

Quality Management

• The fundamental concepts and 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 Foundation Training Assessment Methodology

In order to successfully complete this course, each Learner will need to:

• Complete the course modules and obtain 70% or higher in the final assessment (MCQ-based) within the 90-day course license

ISO 13485 Foundation Training Certification

This course is certified by CQI & IRCA (No. 2327). Successful completion will entitle each Learner to receive a digital Certificate of Completion.

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.