How to Implement Risk Management Principles and Activities within a Quality Management System
Instructor:
Thomas Gray
Product ID: 701224
- Duration: 60 Min
Why Should You Attend:
Organizations in the Medical Device Industry are required to demonstrate that there is a documented risk management system in place, no matter what the probability or the severity of the risk is, to show that the device is safe". So as part of your ISO 13485 Quality Management System Program, all organizations will also need to comply with ISO 14791:2007. This standard provides a framework that a medical device manufacturer can use to develop a risk management system.
The standard requires the manufacturer to identify the hazards associated with their products, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. The requirements of the standard apply at all stages of the product’s life cycle -from concept through post-production - ultimately leading to reduced risk due to possible hazards with the product.
Areas Covered in the seminar:
- The Risk Management Process
- Identify the Hazard.
- Estimate Risk.
- Determine if the Level of Risk is Acceptable.
- Implement Risk Management Strategies.
- Control and Review Risk.
- Common Pitfalls in Implementing Risk Management and How to Avoid Them.
- The Definitions of Risk and Hazard.
- Real-Life Case Studies on the Use of Risk Management in Quality Management Systems.
Who will benefit:
This Webinar will provide valuable assistance to all managers who participate in ISO-based Quality Management System Reviews. The employees who will benefit include:
- Senior Managers, Managers & Supervisors
- Process Owners
- QA and Continual Improvement Managers and Personnel
- Management Review Committee Members
- Consultants
Thomas Gray, is founder and President of Productivity Improvement Network, Inc. (PIN), a consulting firm that specializes in quality systems/quality tools, lean, and operations management. Tom worked 15 years in various capacities supporting the automotive, aerospace and healthcare industries. He has assisted companies gain registration to ISO 9001, TS-16949, AS9100, ISO 13485, and Nadcap. In addition, Tom has helped organizations develop and implement Lean tools and techniques, including Value Stream Mapping, 5S, KanBan, Total Productive Maintenance, and Set-Up Reduction. Tom has a BSChe from the University of Massachusetts at Amherst and an MBA from the University of Massachusetts at Dartmouth.
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