This five-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.
ISO 13485 is a Quality Management Standard for Medical Devices. Many medical device
companies are utilizing ISO 13485:2003 as a platform to build their business management
systems because of its benefits or because it is a necessary step to market their
products and services in certain regions. For many companies, registration to ISO
13485 is a key to securing and maintaining global business. This course meets the
training portion of the requirements for certification of individual internal auditors.
The seminar will include an explanation of ISO 13485:2003 and audit systems, the
auditing process and audit instruments; documentation process, how to conduct an
audit, how to write the audit report, and take corrective action; auditing case
studies to develop skills for identifying nonconformance.
Who Should Attend
Quality Assurance Managers, General Managers, ISO 13485:2003 Implementation Team
Members, Management Representatives, and ISO 9001:2008 Internal Auditors should
attend this seminar.
Working knowledge of ISO 9000:1994, ISO 13485:1996, GMP or QSR Standards.
Seminar manual with case study and guide for auditing the standard will be provided
- 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)
- Understand the ISO 13485:2003 auditing and registration process
- Understand each element of ISO 13485:2003
- Prepare, perform and complete an audit
- 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
- Interpreting and auditing to the ISO 13485:2003 standard
- Documentation of a Quality System
- Introduction to Quality Audits
- Management of Audit Programs
- Planning, Preparation, and Performing Audit
- Recording Evidence
- Closing Meeting and completing audit report
- Corrective Action and follow-up