[Skip to main content](https://www.ketryx.com/white-papers/qms-optimization-workshop-template#) Template # QMS Optimization Workshop Template This practical workshop template is designed to guide regulated teams in regular QMS reviews to identify process debt and apply a modern, risk-based, AI-assisted approach to quality processes. No items found. [](https://www.ketryx.com/white-papers/qms-optimization-workshop-template#) [](https://www.ketryx.com/white-papers/qms-optimization-workshop-template#) Even well-designed QMS processes accumulate friction over time: extra fields, duplicated information, manual checks, and unclear ownership that slow teams down. This workshop template gives you a structured way to step back, evaluate your lifecycle artifacts (change requests, requirements, anomalies, test flows, and releases), and redesign them for clarity, speed, and confidence. Built around a proven 90-minute session, it guides product, engineering, and quality leaders through identifying pain points, spotting quick wins, applying a risk-based approach, and defining where automation and AI can enforce compliance. Your team will emerge from the workshop with a leaner, more scalable QMS that increases velocity, strengthens traceability, and reduces documentation effort while also strengthening safety and audit-readiness. ##### **What You’ll Learn** - How to identify and eliminate process debt in your QMS - A repeatable method for applying a risk-based approach - How to distinguish between compliance-critical information and noise - Practical techniques to streamline change requests, anomalies, requirements, and test workflows - When and how to shift documentation closer to code - How to leverage AI and automation to enforce consistency and traceability - Collaboration patterns that align Product, Engineering, and Quality around speed and safety - How to run a 90-minute QMS optimization workshop that drives real change - Best practices for turning workshop outcomes into SOP updates, template changes, and implementation plans Get the Template Conversion Page Landing Page utm\_campaign utm\_content utm\_medium utm\_source utm\_term ## More resources [Template\\ \\ **FDA Predetermined Change Control Plan (PCCP) Template**\\ \\ This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices.\\ \\ Read more](https://www.ketryx.com/white-papers/pccp-template) [Checklist\\ \\ **IEC 62304 Compliance Checklist**\\ \\ Companies can take a few key steps to simplify their FDA compliance journey and start building medical software. Use this checklist to go through these key steps.\\ \\ Read more](https://www.ketryx.com/white-papers/iec-62304-compliance-checklist) [White Paper\\ \\ **The Cost of Quality**\\ \\ What is quality and why can it make creating products more expensive? What is the cost of creating high quality products?\\ \\ Read more](https://www.ketryx.com/white-papers/the-cost-of-quality)