For the entire history of manufacturing, there has always been a need to establish and maintain some kind of quality standard for the results of production. Whether you're a medical device manufacturer making in-vitro diagnostic devices that will be used in thousands of hospitals, or a factory making bricks that will be used in thousands of homes, quality and consistency throughout the production process
Throughout the medical device industry, you'll hear product development engineers using the terms quality assurance and quality control interchangeably. And that's fine - the two processes are intimately connected - but they do have slightly different definitions that are useful to understand.
Quality assurance is a process management activity that focuses on ensuring that the processes used to create a product produce as few defects as possible. QA activities are conducted with the goal of ensuring that processes are consistent and effective at producing their desired outcome.
Quality control deals with the finished product and is a set of processes for ensuring that defective products do not reach the customer. Inspecting and sampling the products that come out of the manufacturing process are core aspects of quality control.
Quality assurance encompasses a set of policies and procedures for ensuring quality in the manufacturing process and continuously improving the consistency with which conforming products can be produced. Here are some of the most important procedures that can comprise an effective QA system:
Continuous improvement is an overarching theme of 21 CFR Part 820, the quality system regulations that are mandated for medical devices companies in the United States, as well as the International Standard for medical device quality systems, ISO 13485. The most important requirements for QA systems are actually written into these standards explicitly for medical device companies to follow:
Greenlight Guru's QMS Software provides a central hub for all of your medical device company's quality assurance activities. It's never been easier to securely store and access your internal audit results, CAPA files, product testing documentation, and other QA items, and you'll find FDA audits happen very smoothly when you invest in ensuring the organization and accessibility of all your QA documents.
Greenlight Guru’s QMS Software also makes it easy for your quality manager to quickly sort through all of the quality data related to your product, meaning faster and more timely process improvements and effective continuous development of quality practices that help your product succeed.