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?
Why should you Attend:
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 Session:
How does a Quality Manual provide value; even if your standard no longer specifically requires one?
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
- Quality Manager
- Quality Director
- Quality Systems Specialist
- Quality Engineer
- Regulatory Affairs Manager
- Regulatory Affairs Director
- Regulatory Affairs Specialist
• Quality Manager
• Quality Director
• Quality Systems Specialist
• Quality Engineer
• Regulatory Affairs Manager
• Regulatory Affairs Director
• Regulatory Affairs Specialist