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ISO 13485 A Complete Guide

ISO 13485 A Complete Guide

$199.00
When you get access:
Course access is prepared after purchase and delivered via email
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Self-paced • Lifetime updates
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Toolkit Included:
Includes a practical, ready-to-use toolkit with implementation templates, worksheets, checklists, and decision-support materials so you can apply what you learn immediately - no additional setup required.
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What does the ISO 13485 course cover?

ISO 13485 is covered here in 10 modules: Introduction to ISO 13485: Key principles and concepts, Overview of the ISO 13485 standard, Quality Management System (QMS) Requirements: QMS framework and structure, Design and Development Controls: Design changes and revisions, Design and development process and 7 more.

How do you approach ISO 13485 step by step?

The work is sequenced in 10 stages. It starts with introduction to ISO 13485: Key principles and concepts, Overview of the ISO 13485 standard, moves through Quality Management System (QMS) Requirements: QMS framework and structure and Design and Development Controls: Design changes and revisions, Design and development process, and ends at ISO 13485 Certification and Audits: Audit process and procedure.

What is in Module 1 of the ISO 13485 course?

Module 1 is Introduction to ISO 13485: Key principles and concepts, Overview of the ISO 13485 standard. It works through overview of the ISO 13485 standard, history and development of the standard, key principles and concepts and 1 more. It sets the vocabulary the remaining 9 modules build on.

How is the ISO 13485 course delivered?

The ISO 13485 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.

How much does the ISO 13485 course cost?

The ISO 13485 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.

More answers: what you get with every course, refund policy, all help answers.

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: Key principles and concepts, Overview of the ISO 13485 standard

  • 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

  • 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 changes and revisions, Design and development process

  • Design and development process
  • Design input and output requirements
  • Verification and validation activities
  • Design changes and revisions

Module 4. Production and Service Controls: Service provision and delivery

  • Production planning and control
  • Service provision and delivery
  • Product identification and traceability
  • Product preservation and storage

Module 5. Purchasing and Supplier Controls: Supplier evaluation and monitoring

  • Purchasing process and supplier selection
  • Supplier evaluation and monitoring
  • Purchasing information and documentation
  • Supplier corrective action and improvement

Module 6. Identification and Traceability: Barcode and RFID technology

  • Product identification and labeling
  • Product traceability and tracking
  • Unique device identification (UDI)
  • Barcode and RFID technology

Module 7. Control of Nonconforming Product: Nonconforming product reporting and trending

  • 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

  • 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 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: Audit process and procedure

  • 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
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