Undertanding ISO 13485: Medical Device Quality Management Systems

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Engineers often move into assignments such as Quality Engineer, Quality Manager, Project Quality Leader, etc. as they progress on their career path. While the typical engineer may understand portions of the quality management system in their organization, they may not have had the opportunity to learn how to organize and deploy an effective Quality Assurance department. Moving into the role of Quality Leader or Manager can be a natural career progression, thus learning about the functions, roles and responsibilities for a typical QA department or team can be important to career development and success.

Leading or managing the quality team in an organization involves understanding the roles and responsibilities of a typical Quality Assurance department, which is the focus of this course. A Simple & Effective Approach to Quality Assurance provides engineers and managers with the information necessary to organize and lead an effective QA department. This class will help you prepare for a role in quality leadership, or if you’re already in such a position, it will help you be more successful.

A Simple & Effective Approach to Quality Assurance provides useful information that will enable you and your organization to clearly define the roles and responsibilities for your QA function. This class will help you organize an effective QA department and includes:
     • Quality Management Review
     • Overview of the Core Functions of a Quality Department
     • Introduce a Typical Quality Department Organization
     • Understand Essential Responsibilities and Tasks in the QA Department

The instructor for A Simple & Effective Approach to Quality Assurance, Davis Woodruff, has over three decades of real-world experience with clients on 3 continents and in 35 states. He uses a practical approach based on actual experiences.

The learning objectives are for participants to:
     1. Know the 3 Core Functions of a Quality Assurance Department
     2. Understand how a Typical Quality Assurance Department is Organized
     3. Know the Essential Responsibilities and Tasks for a QA Department

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Undertanding ISO 13485: Medical Device Quality Management Systems