A Quality Management System (QMS) is a framework of processes and procedures that helps a company make products with consistent quality and stay in regulatory compliance. Quality Management Systems aren’t exclusive to highly regulated industries such as the medical device and pharmaceutical industry, but they are required by FDA in these fields. A robust QMS is essential for maintaining base business functions, running efficiently, saving costs, providing a high-quality product to customers and staying in compliance.
Some of the core components of a quality management system are managing audits, CAPA, change control, complaint management, controlling equipment, design and development, deviation management, document control, engineering records, inspections, management review, quality data analysis, quality manual, risk management, statistical techniques, supplier management, training management, and validation management. There are a wide variety of standards and regulations in the US and other countries that govern pharma and med device quality management systems.
In order to create and implement a QMS, you must first assess your business’s product types, major functions, and regulatory requirements. Next each process must be carefully defined, and personnel should be assigned responsibilities. This is where the key documents and structure of the QMS are built. Next, the QMS is released and deployed. During this process, staff must be educated on the new processes in the QMS so they can properly follow them. Then the QMS must be controlled and measured through routine audits. Lastly, the QMS is a growing system, and the results of the audit should be reviewed and considered to make processes more effective and efficient. If you need assistance developing and implementing a QMS, EMMA International can help you.
EMMA International is here to provide full-circle solutions for all aspects of medical device and pharmaceutical industries. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!
