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

A summary of learning topics within this course include:

• 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
• 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

This course is targeted at:

• • Quality Managers
  • Quality Professionals/Technicians
  • Quality Engineers
  • Procurement Personnel
  • Financial Personnel
  • Document Controllers
  • Internal Auditors
  • Owner Managers
  • Implementation Members

CQI & IRCA certify this course (No. 2327). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.

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

• 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 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.

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

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.