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Understanding and Implementing ISO 13485:2003 For Medical Devices

Seminar Content

This two-day course provides a comprehensive discussion of the requirements of ISO 13485:2003 including key changes from the ISO 13485:1996 standard. It also covers the general approach to upgrading to, or implementing a quality management system based upon ISO 13485:2003.

The class will cover the FDA 21 CFR 82030 for design control guidance for Medical Device Manufacturers, the section of the Food, Drug and Cosmetic Act relating to Medical Devices, Labeling for Medical Devices, US FDA QSR regulations and Good Manufacturing Practices (GMP), Post Market Surveillance, and Human Factors in Medical Device Design.

Who Should Attend

Quality Assurance Managers, General Managers, ISO Implementation Team Members, Management Representatives, and ISO Internal Auditors should attend this course.

Recommended Training and/or Experience

Working knowledge of ISO 9000, ISO 13485:1996, GMP or QSR Standards.

Seminar Materials

Each participant will receive a seminar manual including any applicable case studies.

Seminar Goals

• Explain the background and goals of ISO 13485:2003 and FDA GMP Compliance Goals for Medical Devices
  • Discussion on Class 1, 2a, 2b and 3/4 medical devices and risk mitigation
• Provide an understanding of ISO 13485:2003 requirement
• Outline the steps for implementing or updating a quality management system to the ISO 13485:2003 requirements
• Provide Best-in-Class quality management system concepts and approaches
• Understanding of the US Federal Regulations (detailed) including Canadian, European, and Japanese (summary)

Seminar Outline

• Overview of ISO 13485:2003 Family of Standards
• ISO 13485:2003 Quality Management System
• Explanation of ISO 13485:2003 Requirements
• Management Responsibility
• Resource Management
• Product Realization, Design Control and Risk Mitigation
  • Design Control Guidance - FDA 21 CFR 820.30 and subclause 4.4 of ISO 9001.
• Measurement, Analysis and Improvement
• US FDA QSR regulation and Good Manufacturing Practices (GMP).
• Differences and Additions to ISO 13485
• US Medical Devices Regulations including Food, Drug and Cosmetic Act relating to Medical Devices, Labeling for Medical Devices, US FDA QSR regulations and Good Manufacturing Practices (GMP), Post Market Surveillance, and Human Factors in Medical Device Design.
• Defining Quality Policy and Objectives
• Developing a Quality Management System Plan
• Documenting a Quality Management System
• Developing Quality Plans
• Implementing a Quality Management System
• Monitoring a Quality Management System
• Conducting Management Reviews

Course Sequence: UI13485

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