Management Responsibilities for QSR Initiative

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.

Bonus Materials:

Participants receive checklists to help ensure effective implementation of the management responsibility.

Areas Covered in the Webinar:

• Understand the required elements to implement management responsibility
• Understand the differences between QSR and ISO 13485:2016
• Develop unified documents and records for a combined system
• Understand the role of the Quality System Record
• Learn how FDA Investigators use QSIT to check your implementation
• Learn how MDSAP Auditors use the audit model to check your implementation
• Review Warning Letters to learn implementation problems

Who Will Benefit:

All people involved in the management responsibility system should attend. In particular:

• Top Management
• Management Representative
• Management Review Participants
• Quality Managers
• Audit Managers
• Managers responsible for the Quality Plan

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 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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