ISO 13485: A Complete Guide
Certificate Course Curriculum Upon completion of this comprehensive course, participants will receive a certificate issued by The Art of Service.
Course Overview This interactive and engaging course provides a thorough understanding of the ISO 13485 standard, with a focus on practical, real-world applications. Our expert instructors will guide you through the course material, ensuring that you gain actionable insights and hands-on experience.
Course Features - Interactive and engaging content
- Comprehensive and personalized learning experience
- Up-to-date and high-quality content
- Expert instructors with extensive industry experience
- Certificate issued by The Art of Service upon completion
- Flexible learning options, including mobile accessibility
- User-friendly interface and community-driven learning environment
- 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 ISO 13485
Module 2: Quality Management System (QMS) Requirements
- QMS framework and structure
- Responsibilities and roles within the QMS
- Documentation and record-keeping requirements
- Management review and continuous improvement
Module 3: Design and Development Controls
- Design and development process
- Design input and output requirements
- Verification and validation activities
- Design changes and revisions
Module 4: Production and Service Controls
- Production planning and control
- Service provision and delivery
- Product identification and traceability
- Product preservation and storage
Module 5: Purchasing and Supplier Controls
- Purchasing process and supplier selection
- Supplier evaluation and monitoring
- Purchasing information and documentation
- Supplier corrective action and improvement
Module 6: Identification and Traceability
- Product identification and labeling
- Product traceability and tracking
- Unique device identification (UDI)
- Barcode and RFID technology
Module 7: Control of Nonconforming Product
- Nonconforming product identification and segregation
- Nonconforming product disposition and correction
- Corrective action and preventive action (CAPA)
- Nonconforming product reporting and trending
Module 8: Corrective Action and Preventive Action (CAPA)
- CAPA process and procedure
- Corrective action and preventive action implementation
- CAPA effectiveness and verification
- CAPA documentation and record-keeping
Module 9: Internal Audits and Management Review
- Internal audit process and procedure
- Internal audit planning and execution
- Internal audit reporting and follow-up
- Management review and continuous improvement
Module 10: ISO 13485 Certification and Audits
- ISO 13485 certification process and requirements
- Audit preparation and readiness
- Audit process and procedure
- Audit follow-up and corrective action
Bonus Materials - ISO 13485 standard document
- Implementation toolkit and templates
- Case studies and industry examples
- Additional resources and references
Course Format This course is delivered in a flexible and user-friendly format, with interactive and engaging content, including: - Bite-sized lessons and modules
- Video lectures and presentations
- Quizzes and assessments
- Hands-on projects and activities
- Discussion forums and community interaction
Course Duration This course is designed to be completed in approximately 80 hours, with flexible pacing and lifetime access to course materials.
Course Prerequisites There are no prerequisites for this course, although prior knowledge of quality management systems and ISO standards may be beneficial.
Target Audience This course is designed for professionals involved in the development, implementation, and maintenance of quality management systems, including: - Quality managers and directors
- Regulatory affairs professionals
- Compliance officers
- Auditors and assessors
- Manufacturing and production personnel
- Design and development engineers
- Supply chain and purchasing professionals
,
Course Features - Interactive and engaging content
- Comprehensive and personalized learning experience
- Up-to-date and high-quality content
- Expert instructors with extensive industry experience
- Certificate issued by The Art of Service upon completion
- Flexible learning options, including mobile accessibility
- User-friendly interface and community-driven learning environment
- 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 ISO 13485
Module 2: Quality Management System (QMS) Requirements
- QMS framework and structure
- Responsibilities and roles within the QMS
- Documentation and record-keeping requirements
- Management review and continuous improvement
Module 3: Design and Development Controls
- Design and development process
- Design input and output requirements
- Verification and validation activities
- Design changes and revisions
Module 4: Production and Service Controls
- Production planning and control
- Service provision and delivery
- Product identification and traceability
- Product preservation and storage
Module 5: Purchasing and Supplier Controls
- Purchasing process and supplier selection
- Supplier evaluation and monitoring
- Purchasing information and documentation
- Supplier corrective action and improvement
Module 6: Identification and Traceability
- Product identification and labeling
- Product traceability and tracking
- Unique device identification (UDI)
- Barcode and RFID technology
Module 7: Control of Nonconforming Product
- Nonconforming product identification and segregation
- Nonconforming product disposition and correction
- Corrective action and preventive action (CAPA)
- Nonconforming product reporting and trending
Module 8: Corrective Action and Preventive Action (CAPA)
- CAPA process and procedure
- Corrective action and preventive action implementation
- CAPA effectiveness and verification
- CAPA documentation and record-keeping
Module 9: Internal Audits and Management Review
- Internal audit process and procedure
- Internal audit planning and execution
- Internal audit reporting and follow-up
- Management review and continuous improvement
Module 10: ISO 13485 Certification and Audits
- ISO 13485 certification process and requirements
- Audit preparation and readiness
- Audit process and procedure
- Audit follow-up and corrective action
Bonus Materials - ISO 13485 standard document
- Implementation toolkit and templates
- Case studies and industry examples
- Additional resources and references
Course Format This course is delivered in a flexible and user-friendly format, with interactive and engaging content, including: - Bite-sized lessons and modules
- Video lectures and presentations
- Quizzes and assessments
- Hands-on projects and activities
- Discussion forums and community interaction
Course Duration This course is designed to be completed in approximately 80 hours, with flexible pacing and lifetime access to course materials.
Course Prerequisites There are no prerequisites for this course, although prior knowledge of quality management systems and ISO standards may be beneficial.
Target Audience This course is designed for professionals involved in the development, implementation, and maintenance of quality management systems, including: - Quality managers and directors
- Regulatory affairs professionals
- Compliance officers
- Auditors and assessors
- Manufacturing and production personnel
- Design and development engineers
- Supply chain and purchasing professionals
,
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 ISO 13485
Module 2: Quality Management System (QMS) Requirements
- QMS framework and structure
- Responsibilities and roles within the QMS
- Documentation and record-keeping requirements
- Management review and continuous improvement
Module 3: Design and Development Controls
- Design and development process
- Design input and output requirements
- Verification and validation activities
- Design changes and revisions
Module 4: Production and Service Controls
- Production planning and control
- Service provision and delivery
- Product identification and traceability
- Product preservation and storage
Module 5: Purchasing and Supplier Controls
- Purchasing process and supplier selection
- Supplier evaluation and monitoring
- Purchasing information and documentation
- Supplier corrective action and improvement
Module 6: Identification and Traceability
- Product identification and labeling
- Product traceability and tracking
- Unique device identification (UDI)
- Barcode and RFID technology
Module 7: Control of Nonconforming Product
- Nonconforming product identification and segregation
- Nonconforming product disposition and correction
- Corrective action and preventive action (CAPA)
- Nonconforming product reporting and trending
Module 8: Corrective Action and Preventive Action (CAPA)
- CAPA process and procedure
- Corrective action and preventive action implementation
- CAPA effectiveness and verification
- CAPA documentation and record-keeping
Module 9: Internal Audits and Management Review
- Internal audit process and procedure
- Internal audit planning and execution
- Internal audit reporting and follow-up
- Management review and continuous improvement
Module 10: ISO 13485 Certification and Audits
- ISO 13485 certification process and requirements
- Audit preparation and readiness
- Audit process and procedure
- Audit follow-up and corrective action
Bonus Materials - ISO 13485 standard document
- Implementation toolkit and templates
- Case studies and industry examples
- Additional resources and references
Course Format This course is delivered in a flexible and user-friendly format, with interactive and engaging content, including: - Bite-sized lessons and modules
- Video lectures and presentations
- Quizzes and assessments
- Hands-on projects and activities
- Discussion forums and community interaction
Course Duration This course is designed to be completed in approximately 80 hours, with flexible pacing and lifetime access to course materials.
Course Prerequisites There are no prerequisites for this course, although prior knowledge of quality management systems and ISO standards may be beneficial.
Target Audience This course is designed for professionals involved in the development, implementation, and maintenance of quality management systems, including: - Quality managers and directors
- Regulatory affairs professionals
- Compliance officers
- Auditors and assessors
- Manufacturing and production personnel
- Design and development engineers
- Supply chain and purchasing professionals
,
- Bite-sized lessons and modules
- Video lectures and presentations
- Quizzes and assessments
- Hands-on projects and activities
- Discussion forums and community interaction