Quality System Development & Integration

Whether your goal is to establish a compliant quality management system that fits your product and process, or your company is experiencing a merger to blend two systems, Compliance Team can help!

At Compliance Team, we understand that every company is unique, and every company—and every product type—is different.  Specifically, the risks associated with different types of products and production methods signal the areas to emphasize during quality system development.  A risk assessment to evaluate your unique challenges is a sensible way to apply the necessary rigor to the areas of  quality concern, which in turn, provide the structure for a sensible quality management system that meets ISO 13485 and/or 21CFR 820 mandated requirements.

After the risk assessment, Compliance Team creates or evaluates the quality manual to ensure advantageous application of quality resources to provide maximal organizational efficiency and effectiveness.  The goal is to meet regulatory commitments in a way that minimizes hidden quality costs, such as: excessive downtime, reworks, deviations, and material costs.

Each quality system element ideally contributes business value, based on your organization’s specific business needs and company culture.  In other words, we do not offer a “cookie-cutter approach—we listen.

ISO 13485 and the QSR (21 CFR 820) identify the baseline processes for discussion in the quality manual. The manual need not be overly detailed; discuss details in point-of-use procedures. The idea is to show that a company has developed a framework for how the various processes interconnect to form a cohesive whole. With proper forethought, the cohesive whole becomes a lean, mean, profit machine!

How can Compliance Team provide a quality system solution to suit your company’s unique value proposition?