TS-EN-ISO 13485: 2003 standard TS-EN-ISO is based on the 9001: 2000 standard, is an international standard with special requirements for medical devices.
In addition to meeting legal requirements, manufacturers of medical devices who want to gain competitive advantage must prove that they comply with the quality management system requirements.
Medical device manufacturers require the need to establish and certify a quality system in order to meet current legal requirements, ensure customer satisfaction, increase internal efficiency and provide legal assurance against lawsuits.
The EN 46001 / ISO 13485 Management System includes additional specific requirements for medical device manufacturers, including ISO 9000 Quality Management request requirements.
This Standard covers the requirements of a quality management system for an organization that must demonstrate the ability to provide medical devices and consistently meet customer requirements and regulatory requirements applicable to medical device-related services. The main purpose of this standard is to facilitate the requirements of harmonized medical device legislation for quality management systems.
The ability of medical device manufacturers to operate in the European Union and the North American market depends on crossing many legal barriers. In many countries, particularly in Canada, some types of medical device manufacturers have been required by law to establish a quality management system that complies with the ISO 13485 standard.
TS-EN-ISO 13485: The 2003 standard is the latest version of 13485. ISO 9001: 2000 is based on the process approach model. ISO 13485: 2016 and 13488: 2016 are older models of this standard that do not rely on the process approach.
ISO 13485 is the most comprehensive standard in the world in this field that determines the conditions of a quality service process system for institutions that manufacture, sell, develop or provide services. Its main purpose is to contribute to the R&D, design process, medical or medical device development. ISO 13485. standard is that it meets these conditions.
Iso 13485, Medical Devices Standard, supports the quality management processes of the organization and the technical infrastructure related to the product. It is a strategic decision of management to adopt the requirements of this standard. The institution must develop a quality product and identify all needs and processes. Since the size of each organization is different, the way it applies the standard will differ from other factors such as the number of employees. Anyway, the main purpose of the Iso 13485 standard is to provide different solutions based on standard items. The specially created standard specified in the standard is applied to some risky products.
The Iso 13485 standard is a standard for Medical Devices and Medical Devices, and its foundation is based on the Iso 9001 Quality Management system, as in almost all standards. The ISO 14969 standard, which is linked to this standard and aimed at reporting this standard, is also related to this standard.
