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A Process Approach to Quality Management Systems

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.  This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”.  

This webinar will cover the basics of how to establish and maintain a suitable QMS including:

  • The basic requirements
  • Management Responsibility
  • Quality System Processes
  • Process Ownership, Management, and Control
  • Roles and Responsibilities
  • QMS structure
  • Standard Operating Procedures, Work Instructions, Forms, etc.

An efficient, effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed.  More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.  It ensures that processes are well defined, managed, and controlled yielding predictable and acceptable results.  A controlled quality management system avoids unpleasant surprises and resulting rework, delay, and cost.

An ineffective QMS can lead to serious compliance and quality issues including 483 observations, warning letters, and even consent decrees.  Even worse it can lead to inconsistent or poor product quality including non-conformances, complaints, and even recalls.  And an inefficient QMS leads to confusion, inconsistency, excessive rework, corrective and preventive action, and increased cost of quality.  An inefficient QMS results in wasted time, money, and missed opportunities. It is imperative that medical device companies can effectively and efficiently establish a QMS.  

In this 6-hour virtual seminar, we will explore the fundamentals of a Quality Management System and how you can incorporate a process approach to take your program from surviving to thriving.  A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.

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