Mastering ISO 9001:2015 and IEC 62304 - A Step-by-Step Guide to Implementing and Auditing Quality Management Systems for Medical Device Manufacturing and Software Development
Course Overview This comprehensive course provides a step-by-step guide to implementing and auditing quality management systems for medical device manufacturing and software development, in accordance with ISO 9001:2015 and IEC 62304. Participants will gain a deep understanding of the standards and learn how to apply them in a practical and effective manner.
Course Objectives - Understand the requirements of ISO 9001:2015 and IEC 62304
- Learn how to implement a quality management system for medical device manufacturing and software development
- Understand how to audit a quality management system for compliance with ISO 9001:2015 and IEC 62304
- Gain practical experience with hands-on projects and case studies
- Receive a certificate upon completion, issued by The Art of Service
Course Outline Module 1: Introduction to ISO 9001:2015 and IEC 62304
- Overview of ISO 9001:2015 and IEC 62304
- History and development of the standards
- Key concepts and principles
- Relationship between ISO 9001:2015 and IEC 62304
Module 2: Quality Management System Requirements
- Context of the organization
- Leadership and commitment
- Policy and objectives
- Quality management system scope
- Quality management system processes
Module 3: Risk Management and Quality Planning
- Risk management principles and concepts
- Identifying and assessing risks
- Implementing risk mitigation strategies
- Quality planning and objectives
- Quality management system performance evaluation
Module 4: Design and Development Controls
- Design and development planning
- Design and development inputs
- Design and development outputs
- Design and development review and verification
- Design and development validation
Module 5: Production and Service Provision Controls
- Production planning and control
- Service provision planning and control
- Identification and traceability
- Property of customers or external providers
- Preservation of product
Module 6: Auditing and Compliance
- Auditing principles and concepts
- Audit planning and preparation
- Audit execution and reporting
- Audit follow-up and closure
- Compliance with regulatory requirements
Module 7: Software Development and Validation
- Software development life cycle
- Software design and development controls
- Software testing and validation
- Software release and maintenance
- Software risk management
Module 8: Medical Device Manufacturing and Quality Controls
- Medical device manufacturing processes
- Quality controls for medical device manufacturing
- Sterilization and packaging controls
- Labeling and instructions for use
- Medical device risk management
Module 9: Quality Management System Performance Evaluation
- Quality management system monitoring and measurement
- Quality management system analysis and evaluation
- Quality management system improvement
- Quality management system review and revision
Module 10: Implementation and Certification
- Implementation planning and preparation
- Implementation execution and monitoring
- Certification audit preparation and execution
- Certification audit follow-up and closure
Course Features - Interactive and engaging content
- Comprehensive and up-to-date materials
- Personalized learning experience
- Practical and real-world applications
- High-quality content and expert instructors
- Certification upon completion, issued by The Art of Service
- Flexible learning options and user-friendly interface
- Mobile-accessible and community-driven
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking
Certificate Upon completion of the course, participants will receive a certificate issued by The Art of Service. This certificate is a recognition of the participant's achievement and demonstrates their expertise in implementing and auditing quality management systems for medical device manufacturing and software development, in accordance with ISO 9001:2015 and IEC 62304.,
- Understand the requirements of ISO 9001:2015 and IEC 62304
- Learn how to implement a quality management system for medical device manufacturing and software development
- Understand how to audit a quality management system for compliance with ISO 9001:2015 and IEC 62304
- Gain practical experience with hands-on projects and case studies
- Receive a certificate upon completion, issued by The Art of Service
Course Outline Module 1: Introduction to ISO 9001:2015 and IEC 62304
- Overview of ISO 9001:2015 and IEC 62304
- History and development of the standards
- Key concepts and principles
- Relationship between ISO 9001:2015 and IEC 62304
Module 2: Quality Management System Requirements
- Context of the organization
- Leadership and commitment
- Policy and objectives
- Quality management system scope
- Quality management system processes
Module 3: Risk Management and Quality Planning
- Risk management principles and concepts
- Identifying and assessing risks
- Implementing risk mitigation strategies
- Quality planning and objectives
- Quality management system performance evaluation
Module 4: Design and Development Controls
- Design and development planning
- Design and development inputs
- Design and development outputs
- Design and development review and verification
- Design and development validation
Module 5: Production and Service Provision Controls
- Production planning and control
- Service provision planning and control
- Identification and traceability
- Property of customers or external providers
- Preservation of product
Module 6: Auditing and Compliance
- Auditing principles and concepts
- Audit planning and preparation
- Audit execution and reporting
- Audit follow-up and closure
- Compliance with regulatory requirements
Module 7: Software Development and Validation
- Software development life cycle
- Software design and development controls
- Software testing and validation
- Software release and maintenance
- Software risk management
Module 8: Medical Device Manufacturing and Quality Controls
- Medical device manufacturing processes
- Quality controls for medical device manufacturing
- Sterilization and packaging controls
- Labeling and instructions for use
- Medical device risk management
Module 9: Quality Management System Performance Evaluation
- Quality management system monitoring and measurement
- Quality management system analysis and evaluation
- Quality management system improvement
- Quality management system review and revision
Module 10: Implementation and Certification
- Implementation planning and preparation
- Implementation execution and monitoring
- Certification audit preparation and execution
- Certification audit follow-up and closure
Course Features - Interactive and engaging content
- Comprehensive and up-to-date materials
- Personalized learning experience
- Practical and real-world applications
- High-quality content and expert instructors
- Certification upon completion, issued by The Art of Service
- Flexible learning options and user-friendly interface
- Mobile-accessible and community-driven
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking
Certificate Upon completion of the course, participants will receive a certificate issued by The Art of Service. This certificate is a recognition of the participant's achievement and demonstrates their expertise in implementing and auditing quality management systems for medical device manufacturing and software development, in accordance with ISO 9001:2015 and IEC 62304.,
- Interactive and engaging content
- Comprehensive and up-to-date materials
- Personalized learning experience
- Practical and real-world applications
- High-quality content and expert instructors
- Certification upon completion, issued by The Art of Service
- Flexible learning options and user-friendly interface
- Mobile-accessible and community-driven
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking