Metrics and Management for a Suitable and Effective QMS

Why Should You Attend:

Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus. Yet, they are frequently unaware of their responsibilities, leading to compliance issues, quality problems, and customer dissatisfaction. Management is unaware of gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight metrics to ensure your management is well informed on the health of the QMS, and provides the right level of oversight, attention, and resources.

Areas Covered in the Webinar:

This 90-minute webinar will include:

• Regulatory Expectations for Management Responsibility and Management Review
• Park Doctrine
• Lessons Learned
• Metrics to monitor the health of your QMS
• Effective Management Review
• How a culture of quality and compliance can encourage clear and transparent communication of risk.
• How to prioritize, resource, and implement improvements
• Tools for monitoring and communicating risk and improvement over time.
• How to identify residual risk.
• Signs that your company culture is taking unnecessary compliance or quality risk.

Who Will Benefit:

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Auditors
• Auditor Managers
• Supplier Auditors
• Training Specialists
• CAPA Specialists
• Quality/Compliance leaders, managers, or directors for Medical Device companies
• General Managers wanting to learn how to Management Review and expectations

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

Frequently Asked Questions:

1. How to implement the Check phase (Performance Evaluation) in the QMS according to ISO 9001:2015?
2. How to make Management Review more useful in the QMS?
3. How to comply clause for performance monitoring in line with our business. As a compliance obligation, we determined/set TAT for our frontline services and made it available to the public as a requirement. Our certifying body keeps on raising that we should have a means to monitor and analyze if we are meeting the TATs we set. So should we have to come up with a program to MONITOR if these TATs are met?

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