Why Should You Attend:
Management responsibility is the name of a QSR section that describes how top management sets up the quality system. There are significant elements of this system that are essential to a smooth running QMS. Understanding them is vital. In addition, ISO 13485:2016 mirrors the QSR requirements, but also diverges. For example, QSR requires a quality policy and quality objectives, while ISO 13485:2016 adds some specific areas to include.
Other QSR sections support management responsibility. For example, the quality audit program provides information to management on the QMS effectiveness. The Quality System Record contains necessary QMS information.
This presentation explains the required elements of management responsibility and the supporting sections. The approach looks at QSR as seen through the regulations, the preamble, QSIT, and Warning Letters. In addition, the presentation looks at the ISO 13485:2016 requirements, the handbook, and the MDSAP audit criteria. The result is a unified explanation of how to meet the combined requirements of both systems.
Participants receive checklists to help ensure effective implementation of the management responsibility.
Areas Covered in the Webinar:
Who Will Benefit:
All people involved in the management responsibility system should attend. In particular:
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 Master’s 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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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