This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality System requirements. Medical device companies are utilizing ISO standards to build their business management systems because of their benefits and as a necessary step to market their products globally.
During this webinar we will discuss the documentation process, and implementing a management system to meet the requirements of ISO and QSR and the operational objectives of the company.
This course will provide guidance on best practices for developing a compliant QMS. We will explore strategies for dealing with common documentation and compliance issues. The course also summarizes the essential documentation requirements and gives an introduction to the key elements for implementation of a compliant system.
Areas to be Covered:
Understand the Quality Management Principles
Discuss the benefits of an effective QMS
Review the Quality Essentials
Understand the required documentation:
Identifying Exempt sections & how to document
Managing and maintaining your QMS
Who will Benefit:
New Quality Assurance Managers
ISO 13485/9001 Implementation Team Members,