Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

Instructor: Daniel O Leary
Product ID: 703752
  • Duration: 90 Min
Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.
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Why Should You Attend:

Customer satisfaction is an important area for any manufacturer. Measuring and monitoring customer satisfaction can help determine the issues that make a business successful.

For medical device manufacturers, the issue is a little different. The Quality Management Systems (QMS), FDA QSR, ISO 13485:2003, and ISO 13485:2016 do not require customer satisfaction measurements because it is not part of a regulatory system. Members of the 13485 family do require collecting feedback on meeting customer requirements, but this is not the same as customer satisfaction, which involves customer expectations.

ISO 10004:2012 provides a model for customer satisfaction. This presentation describes the model and places it in the medical device manufacturing context. For example, the presentation explains the difference between a regulatory complaint and a customer dissatisfaction complaint.

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 presentation explores each element, describes its role in the model, and explains how to apply it.

Areas Covered in the Webinar:

  • Customer satisfaction requirements in a QMS
  • The difference between complaints 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

Who Will Benefit:

  • Quality Managers
  • Regulatory Managers
  • Sales Managers
  • Marketing Managers
  • Project Managers
  • Complaint Handling MDR Specialists
  • Data Analysts
Instructor Profile:
Daniel O Leary

Daniel O Leary
President, Ombu Enterprises, LLC

Dan O'Leary is 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 certified by APICS in Resource Management.

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