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ISO 13485 Complete Self-Assessment Mastery

ISO 13485 Complete Self-Assessment Mastery

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ISO 13485 Complete Self-Assessment Mastery Curriculum



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485 standard and its application in the medical device industry. Through interactive lessons, hands-on projects, and real-world examples, 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 in the medical device industry
  • Develop a comprehensive understanding of the quality management system and its components
  • Learn how to implement and maintain a quality management system that meets the requirements of ISO 13485
  • Gain the knowledge and skills necessary to conduct a self-assessment of an organization's quality management system
  • Understand the importance of continuous improvement and how to implement it in an organization


Course Outline

Module 1: Introduction to ISO 13485

  • Overview of the ISO 13485 standard
  • History and development of the standard
  • Key concepts and principles
  • Benefits of implementing ISO 13485

Module 2: Quality Management System (QMS) Fundamentals

  • Definition and purpose of a QMS
  • Components of a QMS
  • Quality policy and objectives
  • Quality manual and procedures

Module 3: ISO 13485 Requirements

  • 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 4: Self-Assessment and Gap Analysis

  • Understanding the self-assessment process
  • Identifying gaps in the QMS
  • Developing a corrective action plan
  • Implementing changes and improvements

Module 5: Auditing and Certification

  • Understanding the audit process
  • Types of audits (internal, external, certification)
  • Audit planning and preparation
  • Audit execution and follow-up
  • Certification and surveillance audits

Module 6: Continuous Improvement

  • Understanding the importance of continuous improvement
  • Identifying areas for improvement
  • Developing a continuous improvement plan
  • Implementing changes and improvements
  • Monitoring and evaluating progress

Module 7: 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 8: Supply Chain Management

  • Understanding the importance of supply chain management in the medical device industry
  • Developing and implementing a supply chain management strategy
  • Assessing and mitigating supply chain risks
  • Monitoring and evaluating supply chain performance

Module 9: Clinical Evaluation and Post-Market Surveillance

  • Understanding the requirements for clinical evaluation and post-market surveillance
  • Developing and implementing a clinical evaluation plan
  • Conducting post-market surveillance activities
  • Monitoring and evaluating clinical data

Module 10: Regulatory Requirements

  • Understanding regulatory requirements for medical devices
  • Developing and implementing a regulatory strategy
  • Assessing and mitigating regulatory risks
  • Monitoring and evaluating regulatory compliance


Certificate of Completion

Upon completion of this course, participants will receive a Certificate of Completion issued by The Art of Service. This certificate demonstrates that the participant has achieved a comprehensive understanding of the ISO 13485 standard and its application in the medical device industry.



Course Features

  • Interactive and engaging lessons
  • Comprehensive and up-to-date content
  • Practical and real-world applications
  • Expert instructors with industry experience
  • Certification upon completion
  • Flexible learning options (self-paced, online)
  • User-friendly and mobile-accessible platform
  • Community-driven discussion forums
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking
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