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ISO 13485 Quality Management System Self-Assessment and Compliance; A Step-by-Step Guide to Ensuring Total Coverage and Risk Management

ISO 13485 Quality Management System Self-Assessment and Compliance; A Step-by-Step Guide to Ensuring Total Coverage and Risk Management

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ISO 13485 Quality Management System Self-Assessment and Compliance: A Step-by-Step Guide to Ensuring Total Coverage and Risk Management



Course Overview

This comprehensive course provides a step-by-step guide to ensuring total coverage and risk management for organizations seeking to implement or maintain an ISO 13485 Quality Management System. Participants will receive a certificate upon completion, issued by The Art of Service.



Course Features

  • Interactive and engaging content
  • Comprehensive and personalized learning experience
  • Up-to-date and practical information
  • Real-world applications and case studies
  • High-quality content developed by expert instructors
  • Certificate issued upon completion
  • Flexible learning options, including mobile accessibility
  • User-friendly interface and community-driven discussion forum
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to ISO 13485

  • Overview of ISO 13485 and its importance in the medical device industry
  • History and development of the standard
  • Key concepts and principles
  • Benefits of implementing an ISO 13485 Quality Management System

Module 2: Understanding the Requirements of ISO 13485

  • Clause 1: Scope
  • Clause 2: Normative references
  • Clause 3: Terms and definitions
  • Clause 4: Quality management system
  • Clause 5: Management responsibility
  • Clause 6: Resource management
  • Clause 7: Product realization
  • Clause 8: Measurement, analysis, and improvement

Module 3: Self-Assessment and Gap Analysis

  • Understanding the self-assessment process
  • Identifying gaps in the current Quality Management System
  • Developing a plan to address gaps and implement improvements
  • Conducting a self-assessment audit

Module 4: Risk Management

  • Understanding risk management in the context of ISO 13485
  • Identifying and assessing risks
  • Developing and implementing risk mitigation strategies
  • Monitoring and reviewing risk management activities

Module 5: Document Control and Record Keeping

  • Understanding the importance of document control and record keeping
  • Developing a document control system
  • Creating and maintaining records
  • Ensuring compliance with regulatory requirements

Module 6: Internal Audits and Management Review

  • Understanding the importance of internal audits and management review
  • Conducting internal audits
  • Preparing for and conducting management review
  • Ensuring continuous improvement

Module 7: Corrective Action and Preventive Action

  • Understanding the importance of corrective action and preventive action
  • Identifying and addressing nonconformities
  • Developing and implementing corrective actions
  • Developing and implementing preventive actions

Module 8: Continuous Improvement

  • Understanding the importance of continuous improvement
  • Developing a continuous improvement plan
  • Implementing and monitoring continuous improvement activities
  • Ensuring ongoing compliance with regulatory requirements

Module 9: Regulatory Requirements and Compliance

  • Understanding regulatory requirements for medical devices
  • Ensuring compliance with regulatory requirements
  • Maintaining records of compliance
  • Preparing for regulatory audits and inspections

Module 10: Certification and Maintenance

  • Understanding the certification process for ISO 13485
  • Preparing for certification audits
  • Maintaining certification
  • Ensuring ongoing compliance with regulatory requirements

Module 11: Auditing and Inspection

  • Understanding the auditing and inspection process
  • Preparing for audits and inspections
  • Conducting audits and inspections
  • Ensuring compliance with regulatory requirements

Module 12: Implementation and Integration

  • Understanding the implementation and integration process
  • Developing an implementation plan
  • Implementing and integrating the Quality Management System
  • Ensuring ongoing compliance with regulatory requirements

Module 13: Training and Awareness

  • Understanding the importance of training and awareness
  • Developing a training plan
  • Providing training and awareness programs
  • Ensuring ongoing compliance with regulatory requirements

Module 14: Management Review and Evaluation

  • Understanding the importance of management review and evaluation
  • Conducting management review and evaluation
  • Ensuring ongoing compliance with regulatory requirements
  • Maintaining records of management review and evaluation

Module 15: Conclusion and Next Steps

  • Summary of key concepts and takeaways
  • Next steps for implementing and maintaining an ISO 13485 Quality Management System
  • Final thoughts and recommendations


Certificate of Completion

Upon completing this comprehensive course, participants will receive a Certificate of Completion, issued by The Art of Service. This certificate demonstrates the participant's knowledge and understanding of the ISO 13485 Quality Management System and their ability to implement and maintain it in their organization.

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