Introduction to Quality Management for Medical Devices and ISO 13485

Introduction to Quality Management for Medical Devices and ISO 13485

Learn about quality management and the requirements of ISO 13485 during this self-paced, interactive online course.

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About this course

This online course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. It introduces tools and methods on how to work successfully and efficiently within a quality management system.

The course covers the regulatory framework, the quality management system (QMS), documentation pitfalls, risk-based approach, management responsibility, product realization and traceability.

Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate. 

Curriculum10 - 15 hours

  • Introduction
  • Course goals
  • Welcome
  • What is quality management and why it is important
  • Quiz - What is quality management and why it is important
  • The regulations and the standard
  • Quiz - The regulations and the standard
  • Quality management fundamentals
  • What is a quality management system?
  • Quiz - What is a quality management system?
  • Shall or should
  • Quiz - Shall or should
  • The structure of the QMS
  • Quiz - The structure of the QMS
  • Processes, policies and procedures
  • Quiz - Processes, policies and procedures
  • Maintaining the QMS
  • Quiz - Maintaining the QMS
  • The ISO 13485 standard
  • Which standard should you use?
  • Quiz - Which standard should you use?
  • Getting to know the ISO 13485
  • Risk management
  • Risk management in ISO 13485
  • Quiz - Risk management in ISO 13485
  • Audits
  • ISO 13485 stakeholders
  • Quiz - ISO 13485 stakeholders
  • Different types of audits
  • Quiz - Different types of audits
  • ISO 13485 internal audit requirements
  • Quiz - ISO 13485 internal audit requirements
  • Control of documents and records
  • Documents and records
  • Quiz - Documents and records
  • Establish and implement a new document
  • Update and maintain a document
  • Quiz - Update and maintain a document
  • Control of records
  • Quiz - Control of records
  • Management responsibility
  • Quality policy and objectives
  • Quiz - Quality policy and objectives
  • Management review
  • Quiz - Management review
  • Resource management
  • Human resources
  • Responsibility and authority
  • Quiz - Responsibility and authority
  • Infrastructure and work environment
  • Quiz - Infrastructure and work environment
  • Customer related processes
  • Selling a medical device
  • Quiz - Selling a medical device
  • Design and development
  • Design and development and projects
  • Quiz - Design and development and projects
  • Design and development planning
  • Quiz - Design and development planning
  • Design and Development inputs
  • Quiz - Design and Development inputs
  • Design and development outputs
  • Verification and validation
  • Quiz - Verification and validation
  • Design and development transfer
  • Design and development review
  • Quiz - Design and development review
  • Product documentation
  • Quiz - Product documentation
  • Purchasing
  • Purchasing
  • Quiz - Purchasing
  • Production and service
  • Production – Part 1
  • Production – Part 2
  • Quiz - Production
  • Process validation
  • Quiz - Process validation
  • Measuring equipment and calibration
  • Quiz - Measuring equipment and calibration
  • Nonconforming products
  • Quiz - Nonconforming products
  • Design and development changes
  • Design and development changes
  • Quiz - Design and development changes
  • Improvements
  • Feedback and data analysis
  • Quiz - Feedback and data analysis
  • CAPA
  • Quiz - CAPA
  • Complaints
  • Complaints
  • Quiz - Complaints
  • Final exam
  • Final exam - Quality management
  • Course evaluation
  • Course evaluation

About this course

This online course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. It introduces tools and methods on how to work successfully and efficiently within a quality management system.

The course covers the regulatory framework, the quality management system (QMS), documentation pitfalls, risk-based approach, management responsibility, product realization and traceability.

Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate. 

Curriculum10 - 15 hours

  • Introduction
  • Course goals
  • Welcome
  • What is quality management and why it is important
  • Quiz - What is quality management and why it is important
  • The regulations and the standard
  • Quiz - The regulations and the standard
  • Quality management fundamentals
  • What is a quality management system?
  • Quiz - What is a quality management system?
  • Shall or should
  • Quiz - Shall or should
  • The structure of the QMS
  • Quiz - The structure of the QMS
  • Processes, policies and procedures
  • Quiz - Processes, policies and procedures
  • Maintaining the QMS
  • Quiz - Maintaining the QMS
  • The ISO 13485 standard
  • Which standard should you use?
  • Quiz - Which standard should you use?
  • Getting to know the ISO 13485
  • Risk management
  • Risk management in ISO 13485
  • Quiz - Risk management in ISO 13485
  • Audits
  • ISO 13485 stakeholders
  • Quiz - ISO 13485 stakeholders
  • Different types of audits
  • Quiz - Different types of audits
  • ISO 13485 internal audit requirements
  • Quiz - ISO 13485 internal audit requirements
  • Control of documents and records
  • Documents and records
  • Quiz - Documents and records
  • Establish and implement a new document
  • Update and maintain a document
  • Quiz - Update and maintain a document
  • Control of records
  • Quiz - Control of records
  • Management responsibility
  • Quality policy and objectives
  • Quiz - Quality policy and objectives
  • Management review
  • Quiz - Management review
  • Resource management
  • Human resources
  • Responsibility and authority
  • Quiz - Responsibility and authority
  • Infrastructure and work environment
  • Quiz - Infrastructure and work environment
  • Customer related processes
  • Selling a medical device
  • Quiz - Selling a medical device
  • Design and development
  • Design and development and projects
  • Quiz - Design and development and projects
  • Design and development planning
  • Quiz - Design and development planning
  • Design and Development inputs
  • Quiz - Design and Development inputs
  • Design and development outputs
  • Verification and validation
  • Quiz - Verification and validation
  • Design and development transfer
  • Design and development review
  • Quiz - Design and development review
  • Product documentation
  • Quiz - Product documentation
  • Purchasing
  • Purchasing
  • Quiz - Purchasing
  • Production and service
  • Production – Part 1
  • Production – Part 2
  • Quiz - Production
  • Process validation
  • Quiz - Process validation
  • Measuring equipment and calibration
  • Quiz - Measuring equipment and calibration
  • Nonconforming products
  • Quiz - Nonconforming products
  • Design and development changes
  • Design and development changes
  • Quiz - Design and development changes
  • Improvements
  • Feedback and data analysis
  • Quiz - Feedback and data analysis
  • CAPA
  • Quiz - CAPA
  • Complaints
  • Complaints
  • Quiz - Complaints
  • Final exam
  • Final exam - Quality management
  • Course evaluation
  • Course evaluation

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