What does the ISO 13485 Quality Management System course cover?
ISO 13485 Quality Management System is covered here in 8 modules: Introduction to ISO 13485: Overview of ISO 13485, History and development of ISO 13485, Quality Management System Requirements: Human resources and training, Risk Management: tools and techniques, Risk monitoring and review and 5 more.
How do you approach ISO 13485 Quality Management System step by step?
The work is sequenced in 8 stages. It starts with Introduction to ISO 13485: Overview of ISO 13485, History and development of ISO 13485, moves through Quality Management System Requirements: Human resources and training and risk Management: tools and techniques, Risk monitoring and review, and ends at Certification and Accreditation.
What is in Module 1 of the ISO 13485 Quality Management System course?
Module 1 is Introduction to ISO 13485: Overview of ISO 13485, History and development of ISO 13485. It works through overview of ISO 13485, history and development of ISO 13485, key principles and concepts of ISO 13485 and 1 more. It sets the vocabulary the remaining 7 modules build on.
How is the ISO 13485 Quality Management System course delivered?
The ISO 13485 Quality Management System course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.
How much does the ISO 13485 Quality Management System course cost?
The ISO 13485 Quality Management System course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.
Closely related courses: Medical Device Software Quality Management Toolkit, AI-Driven Quality Management for Medical Devices, AI-Driven Quality Management for Medical Device Software, Embedding Quality Culture in Medical Device Compliance.
More answers: what you get with every course, refund policy, all help answers.
ISO 13485 Quality Management System: Mastering Compliance and Risk Management for Medical Devices
Course Overview
This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485 Quality Management System, with a focus on mastering compliance and risk management for medical devices. Participants will gain the knowledge and skills necessary to implement and maintain a quality management system that meets the requirements of ISO 13485.Course Objectives
- Understand the requirements of ISO 13485 and its application to medical devices
- Learn how to implement and maintain a quality management system that meets the requirements of ISO 13485
- Understand the principles of risk management and how to apply them to medical devices
- Gain the knowledge and skills necessary to conduct internal audits and management reviews
- Understand the importance of continuous improvement and how to implement it in a quality management system
Course Outline
Module 1. Introduction to ISO 13485: Overview of ISO 13485, History and development of ISO 13485
- Overview of ISO 13485
- History and development of ISO 13485
- Key principles and concepts of ISO 13485
- Relationship between ISO 13485 and other regulatory requirements
Module 2. Quality Management System Requirements: Human resources and training
- Quality policy and objectives
- Quality manual and procedures
- Organization and management structure
- Responsibilities and authorities
- Human resources and training
- Infrastructure and work environment
Module 3. Risk Management: tools and techniques, Risk monitoring and review
- Principles of risk management
- Risk assessment and analysis
- Risk evaluation and control
- Risk monitoring and review
- Risk management tools and techniques
Module 4: Design and Development
- Design and development planning
- Design and development inputs
- Design and development outputs
- Design and development review
- Design and development verification and validation
Module 5. Production and Service Provision: Validation of processes, Production planning and control
- Production planning and control
- Service provision planning and control
- Validation of processes
- Identification and traceability
- Customer property
Module 6. Measurement, Analysis, and Improvement: Analysis and evaluation, Measurement and monitoring
- Measurement and monitoring
- Analysis and evaluation
- Improvement and corrective action
- Preventive action
- Continuous improvement
Module 7. Internal Audits and Management Reviews: Internal audit execution and reporting
- Internal audit planning and preparation
- Internal audit execution and reporting
- Management review planning and preparation
- Management review execution and reporting
Module 8: Certification and Accreditation
- Certification and accreditation requirements
- Certification and accreditation process
- Maintaining certification and accreditation
Course Features
- Interactive and engaging: The course includes interactive lessons, quizzes, and games to keep participants engaged and motivated.
- Comprehensive and personalized: The course covers all aspects of ISO 13485 and provides personalized feedback and guidance.
- Up-to-date and practical: The course includes the latest developments and best practices in quality management and risk management for medical devices.
- Real-world applications: The course includes real-world examples and case studies to illustrate the application of ISO 13485.
- High-quality content: The course includes high-quality video lessons, animations, and graphics.
- Expert instructors: The course is taught by expert instructors with extensive experience in quality management and risk management for medical devices.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: The course is available online and can be accessed at any time and from any location.
- User-friendly: The course is easy to navigate and includes a user-friendly interface.
- Mobile-accessible: The course can be accessed on mobile devices.
- Community-driven: The course includes a community forum where participants can connect with each other and with the instructors.
- Actionable insights: The course provides actionable insights and practical advice that can be applied immediately.
- Hands-on projects: The course includes hands-on projects and exercises to help participants apply their knowledge and skills.
- Bite-sized lessons: The course includes bite-sized lessons that can be completed in a short amount of time.
- Lifetime access: Participants have lifetime access to the course materials and can review them at any time.
- Gamification: The course includes gamification elements, such as points and badges, to make learning fun and engaging.
- Progress tracking: The course includes progress tracking and reporting to help participants stay on track.