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ISO 13485 Quality Management System; A Complete Guide to Self-Assessment and Implementation

ISO 13485 Quality Management System; A Complete Guide to Self-Assessment and Implementation

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ISO 13485 Quality Management System: A Complete Guide to Self-Assessment and Implementation



Course Overview

This comprehensive course provides a detailed understanding of the ISO 13485 Quality Management System, enabling participants to implement and maintain a quality management system that meets the requirements of the standard. 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 by The Art of Service 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 to course materials
  • Gamification and progress tracking features


Course Outline

Module 1: Introduction to ISO 13485

  • Overview of the ISO 13485 standard
  • History and development of the standard
  • Key principles and concepts
  • Benefits of implementing an ISO 13485 Quality Management System

Module 2: Quality Management System Requirements

  • Quality policy and objectives
  • Quality manual and procedures
  • Organizational structure and responsibilities
  • Training and awareness
  • Documentation and record control

Module 3: Management Responsibility

  • Management commitment and involvement
  • Quality policy and objectives
  • Responsibilities and authorities
  • Communication and reporting
  • Review and evaluation

Module 4: Resource Management

  • Human resources and training
  • Infrastructure and equipment
  • Work environment and safety
  • Financial resources and budgeting
  • Supplier selection and management

Module 5: Product Realization

  • Product planning and development
  • Design and development controls
  • Purchasing and procurement
  • Production and service provision
  • Control of nonconforming products

Module 6: Measurement, Analysis, and Improvement

  • Monitoring and measurement
  • Analysis and evaluation
  • Improvement and corrective action
  • Preventive action and risk management
  • Continuous improvement and innovation

Module 7: Self-Assessment and Implementation

  • Self-assessment and gap analysis
  • Implementation planning and project management
  • Training and awareness programs
  • Documentation and record control
  • Audit and certification preparation

Module 8: Auditing and Certification

  • Audit principles and types
  • Audit planning and preparation
  • Audit execution and reporting
  • Certification and registration
  • Surveillance and recertification audits

Module 9: Maintaining and Improving the Quality Management System

  • Continual improvement and innovation
  • Corrective and preventive action
  • Risk management and mitigation
  • Training and awareness programs
  • Documentation and record control

Module 10: Conclusion and Final Assessment

  • Summary of key concepts and takeaways
  • Final assessment and evaluation
  • Certificate issuance and course completion


Certificate

Upon completion of the course, participants will receive a certificate issued by The Art of Service, demonstrating their knowledge and understanding of the ISO 13485 Quality Management System.

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