A QMS platform provides organizations a controlled and automated way to electronically manage product information and quality processes throughout the product lifecycle. By bringing quality records and the entire product design into one shared system, teams gain greater visibility into product nonconformities which enable them to improve performance and drive greater customer satisfaction while complying with FDA, ISO, and other regulatory standards.
Quality management enables companies that are subject to medical device, export controls, environmental, and/or other safety regulations to streamline compliance. By linking corrective and preventive actions (CAPAs) and other quality processes directly to the product record, teams gain greater visibility into product issues, accelerate resolution, and drive continuous improvement throughout the product lifecycle.
The following standards are commonly used as the basis for establishing a QMS:
Organizations will choose the QMS that best applies to their industry and products.
Read our best practice article to learn everything you need to know about quality management systems (QMS).