Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

Duration: 90 Minutes
The ISO 10004:2012 model has four major elements in the customer satisfaction process: Identifying customer expectations, gathering data, analyzing the data, and communicating the information. The webinar explores each element and explains its application. The webinar also discusses the difference between a complaint in the regulatory realm and a complaint involving only customer satisfaction.
Customer Satisfaction Models
Instructor: Daniel O'Leary
Product ID: 501278
Customer satisfaction is very important to any business, even if it is not a regulatory requirement. However, customer satisfaction measurements can help determine the customer's expectations and provide insight to design features and characteristics that make a medical device a better product. Additionally, the measurement system could uncover latent defects and performance problems that can help improve processes and reduce costs.

Objectives of the Presentation
  • The requirements in a QMS
  • The difference between a complaint in each system
  • Methods to identify customer expectations
  • An explanation of the Kano model to characterize expectations
  • Methods to collect customer satisfaction data
  • An explanation of different survey methods and their applications
  • Techniques to analyze customer satisfaction data
  • Communicating customer satisfaction data
  • Issues related to Management Review
  • Using Preventive Action for improvement
Why Should you Attend
One critical area for any manufacturer is customer satisfaction. Measuring and monitoring customer satisfaction can help determine the issues that make a business successful. It is a major requirement in ISO 9001:2008 and ISO 9001:2015.

For medical device manufacturers, the issue is a little different. The Quality Management Systems (QMS) requirements, such as FDA QSR and ISO 13485:2003, do not require customer satisfaction measurements, because regulators are not in a position to enforce it. However, the information learned measuring customer satisfaction could help uncover issues such as nonconforming products or performance issues.

ISO 10004:2012 provides a model for determining customer satisfaction. This webinar describes the model, and puts it into the context of manufacturing medical devices. For example, the webinar explains the difference between a complaint in the regulatory realm and a complaint involving only customer satisfaction. Attend this webinar to understand the four major elements in the customer satisfaction process in ISO 10004:2012 model.

Who can Benefit
  • Customer satisfaction measures, analysis, and the resulting improvement can affect many parts of the organization. This typically includes:
  • Quality Managers
  • Regulatory Managers
  • Sales Managers
  • Marketing Managers
  • Project Managers
  • Complaint Handling MDR Specialists
  • Data Analysts
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Instructor Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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