Helps introducing safe and effective medical devices.Having a proper QMS in place is essential for medical device-related companies.
#Iso 13485 quality management system iso
Benefits of ISO 13485 / Medical Devices Quality Management System The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies. This standard outlines requirements and procedures that are necessary for manufacturing a specific medical device. Medical Devices Quality Management System Standard focuses on risk factors and monitors the overall product development process.
ISO 13485 emphasizes on medical devices manufacturing industry's regulatory requirements. Needs audit by a Notified Body Class 2b devices Requires a quality management system to ISO 9000 + ISO 13485 and compilation of a technical file to include design. These organizations are usually involved in two or more steps out of design, development, production, distribution, maintenance, storage and installation of medical devices. Class 2a devices Require a quality management system to ISO 9000 + ISO 13485 and a technical file. As per these requirements the organization have to meet customer's satisfaction consistently and also to comply with regulatory requirements.
ISO 13485 pin points requirements of Quality Management System (QMS) for any medical device manufacturing organization. ISO 13485 is an example of a Quality Management System and is specific for Medical Device Manufacturers. Medical devices can be a simple thermometer, micro chip based technology, laser surgical tool, apparatus used in operation etc. A quality management system (QMS) is a set of business processes and procedures focused on consistently meeting customer requirements and enhancing their satisfaction. ISO 13485 - Medical Devices Quality Management System (MDQMS)Īny device or apparatus which is related to health care industry but don't have pharmaceutical action capabilities, is called "Medical Device".
0 kommentar(er)
