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United StatesFDA QMSR Requirements Training (incl. ISO 13485) is for Practitioners and Auditors who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (Revised Part 820).
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Course Overview
FDA QMSR + ISO 13485 Practitioner Training
Understand how the FDA QMSR has evolved to align with ISO 13485 more closely
Outline the structure, content & requirements of both the FDA QMSR and ISO 13485
Understand the key similarities and differences between the FDA QMSR and ISO 13485
Detail the specific quality management-related requirements of the FDA QMSR and ISO 13485
Understand how auditors approach Quality Management System Audits to ensure compliance with the FDA QMSR and ISO 13485
Module 1 – Introduction to the new FDA QMSR
- History of the QMSR
- QMSR Structure
- QMSR Scope
- Definitions
- QMSR and ‘Risk’
Module 2 – Overview of ISO 13485
- Introduction to ISO 13485
- Terms and Definitions
- Plan-Do-Check-Act
- Documentation Requirements
- Process Based QMS
- Risk Based Thinking (RBT)
- Management Commitment
- Related Standards
Module 3 – Establishing a Quality Management System
- Establishing a Quality Management System (QMS)
- QMS Documentation
- Assessing for Conformity
Module 4 – Management Responsibility
- Management Commitment
& Customer Focus - Quality Policy, Objectives & Planning
- Responsibility, Authority
& Communication - Management Review
- Assessing for Conformity
Module 5 – Resource Management
- Provision of Resources
- Infrastructure & Work Environment
- Assessing for Conformity
Module 6 – Product Realization, Part 1
- Planning
- Customer Related Processes
- Design & Development
- FDA Device Classification & Regulatory Controls
- Assessing for Conformity
Module 7 – Product Realization, Part 2
- Purchasing
- Production & Service
- Control of Monitoring & Measuring
- Assessing for Conformity
Module 8 – Measurement, Analysis, and Improvement
- MAI Overview
- Monitoring & Measuring
- Control of Nonconforming Product
- Data Analysis and CAPA
- Assessing for Conformity
This course would be targeted at:
- Quality Engineers
- Quality Specialists
- Internal Auditors
- Lead Auditors
- Quality Managers
- Regulatory Professionals
Upon successful completion, each Learner shall receive a digital Certificate of Achievement 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
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules & associated end-of-module assessments
- Obtain 70% or higher in the final end-of-course assessment (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.
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