Building a Better Quality Manual

Why Should You Attend:

Quality Manuals are too often long documents that contain little more than a regurgitation of the standard requiring the manufacturer to have one. They end up being daunting to employees, confusing to everyone except those in Quality, difficult to maintain, and ultimately, a failure to meet the intent of the standard. In this webinar, attendees will learn to focus on the true intents and requirements for having a Quality Manual, and how to meet them efficiently. Imagine being able to create a fully compliant and effective Quality Manual in as little as 4 pages! What if it were possible to create a Quality Manual as a tri-fold brochure instead of a 3-inch thick binder?

• Have you ever wondered why it takes 20, 40, or even more pages to meet just four requirements stated in ISO 13485?
• Does anyone in your company ever read the Quality Manual other than when it first came out or when they’re required to do an annual acknowledgement?
• More importantly, does anyone other than your Quality staff understand its content?
• Is your Quality Manual designed to just meet the stated requirements rather than achieve their intents?
• Is the content of your Quality Manual redundant with the content of your SOPs?
• Does that redundant content differ because the SOPs were updated and the Quality Manual wasn’t?

Areas Covered in the Webinar:

• How does a Quality Manual provide value; even if your standard no longer specifically requires one?
• Common mistakes
• What are the requirements and what do they actually mean?
• Illustrations vs. words
• Best practices beyond what’s required
• Building a better process model diagram
• Building a better documentation pyramid diagram
• What not to include in the Quality Manual

Who Will Benefit:

• Quality Manager
• Quality Director
• Quality Systems Specialist
• Quality Engineer
• Regulatory Affairs Manager
• Regulatory Affairs Director
• Regulatory Affairs Specialist

Steve Gompertz
President, Quality Management Systems Potential LLC

Steve Gompertz is a leader in Quality Systems management with over 25 years' experience in the life-science industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data. He is currently President of Quality Management Systems Potential LLC, a consulting firm focusing on medical device quality. Steve also helped develop and is an Adjunct Instructor in St. Cloud State University's Master of Science in Medical Technology Quality program. He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management.

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