ABSTRACT

ISO 9001 is a widely recognized standard for quality management that can be applied to various industries, including biomedical engineering. This standard aims to ensure that organizations meet customer and regulatory requirements while continuously improving their processes and products. For biomedical engineering, ISO 9001 provides a framework for managing the design, development, and manufacturing of medical devices and related services. By implementing ISO 9001, biomedical engineering organizations can ensure that their products meet applicable regulatory requirements and are safe for use by patients. ISO 9001 also requires organizations to establish and maintain effective communication and collaboration with stakeholders, including customers, suppliers, and regulatory authorities. This helps to ensure that the organization remains responsive to changes in customer needs and regulatory requirements. Overall, ISO 9001 can help biomedical engineering organizations to improve their quality management systems, enhance customer satisfaction, and maintain compliance with regulatory requirements. This review provides an overview of the key elements of ISO 9001 and discusses how its implementation can benefit the biomedical engineers.