Understanding an ISO 13485 Quality Management System

Description

Get the information you need to understand the ISO 13485:2003 and ISO 9001:2000 standards and how they impact your organization. Dynamic group discussions focus on when compliance or registration is required or desirable, how to document and design an effective quality management system, what the revised requirements mean for the worldwide medical device industry, and what auditors are looking for and finding. Also covered are the steps and potential benefits of registration, such as increased productivity, cost effectiveness, higher perceived quality, enhanced internal and external communication, and competitive advantage.

Topics for this course include:

• Introduction to ISO 13485:2003
• ISO 13485:2003 sections
• Documentation requirements
• Quality system procedures
• ISO 13485:2003 analysis
• Sample procedures
• Introduction to ISO TR 14969

Objectives

• Understand and describe the purpose, benefits and objectives of ISO 13485:2003.
• Explain the similarities and differences between ISO 9001:2000 and ISO 13485:2003.
• Discuss the recent changes to ISO 13485:2003.
• Understand the implications of the medical device industry’s changing standards and regulations.
• Learn how changes to ISO 13485:2003 affect the worldwide medical device community.
• Know how and when to implement your quality system.
• Choose an implementation plan.
• Prepare for a compliance or registration audit.
• Look for common system deficiencies found by external auditors.
• Ensure your system is compliant and effective.

Target Audience

Recommended for medical device and diagnostics industry quality and regulatory professionals who need the latest information on ISO 13485:2003 and ISO 9001:2000, and those responsible for implementing or transitioning to the revised standards.