Establishing a quality management system (QMS) that is both effective and efficient is a challenging but essential part of ensuring quality in your operations. Whether your organization is seeking compliance with standards like ISO 13485 or ISO 9001, or simply looking to enhance internal processes, you’ll need to understand how to build a QMS suited to your unique business needs.
In this article for Medical Design and Outsourcing, Promex’s quality assurance manager, Songlin Li, outlines three key challenges and six steps for building a QMS within a company serving the medical device industry to meet regulatory and customer requirements while staying efficient and scalable.