ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) in the medical device industry. It is designed to help medical device manufacturers and suppliers ensure that their products are safe, effective, and of high quality. Our company offers a range of ISO 13485 QMS services to help our clients achieve compliance with this standard and improve the quality of their products and services.
Our professional team of experts can assist with the development, implementation and maintenance of a Quality Management System that would meet the requirements of ISO 13485 and can also assist with Root Cause Investigation and Corrective Action to ensure that any non-conformities or quality issues are identified and corrected in a timely manner.
The first step in achieving compliance with ISO 13485 is the development of a quality management system (QMS). Our team of experts has the knowledge and experience necessary to assist our clients in the development of a QMS that meets the requirements of the standard. We can provide guidance on everything from the development of policies and procedures to the implementation of a quality manual.
Once a QMS has been developed, it must be implemented in order for it to be effective. Our team can assist with the implementation of the QMS by providing guidance on the development of procedures and work instructions, the training of employees, and the implementation of internal audits. We can also assist with the implementation of a quality management system that complies with the standard and helps your company to improve the quality of its products and services.
ISO 13485 requires that any non-conformities or quality issues be identified and corrected in a timely manner. Our team can assist with the investigation of non-conformities, the identification of the root cause, and the implementation of corrective actions to prevent the problem from recurring in the future. We can assist with the investigation and identification of the root cause of the problem and the implementation of corrective actions to prevent the problem from recurring in the future.