ISO 13485 Medical Devices Quality Management System is prepared based on ISO 9001 Quality Management System published by International Standards Organization. It is based on ISO 9001 standard. In fact, the quality standard is a standard that encompasses organizations from all sectors in order to ensure the management of enterprises in a systematic way. However, there were cases where this standard was not sufficient on sectoral basis. In particular, it cannot be said that it meets all requirements for medical devices, which is a very different area. Based on this need, the International Standards Organization has focused on building sector-based standards. The ISO 2012 Medical Devices Quality Management System standard, which was revised in 13485, has been prepared for this purpose and is a form of ISO 9001 Quality Management System standard which has been adapted and developed in medical devices. This standard is therefore an international standard with special conditions for medical devices.
ISO 13485 standard Although it mainly includes ISO 9001 Quality Management System, it has become a standard for medical device manufacturers especially with its special requirements for sterile medical devices.
ISO 13485 Medical Devices Quality Management System is based on the process approach model such as ISO 9001 Quality Management System. But it is more comprehensive. The ISO 13485 standard sets out the criteria, principles and standards that the medical device manufacturer and service providers must comply with. This standard, which also meets customer requirements and requires compliance with legal regulations, is a great opportunity for companies that want to prove their ability to meet these requirements.
Medical device manufacturers can use ISO 13485 Medical Devices Quality Management System for CE marking for their products. If these companies choose the production quality assurance module within the scope of CE marking, they should already have established the ISO 13485 standard for their business.
The ISO 13485 standard is a standard that defines certain conditions for quality systems for organizations that produce and trade medical devices. This standard can be applied by all organizations involved in the project, production, installation and procurement of medical devices or related services. In other words, the ISO 13485 standard can be applied to all organizations involved in the production and servicing of all products covered by the medical device.
To demonstrate the health and safety features of medical devices and to prove that they meet the minimum requirements, ISO 13485 certification and CE marking work is possible. Therefore, the ISO 13485 standard is closely related to the CE marking operation of medical devices. In this respect, the ISO 13485 standard is a common language adopted by the European Union and other countries in the production, sale and after-sales service of medical devices. It is a very important guide for the sterilization and hygiene of medical devices. The ISO 13485 standard is very specific for the sterile properties of medical devices. It is also an important guide in determining the risk groups and degrees of medical devices.
The ISO 13485 standard is the quality standard of the medical sector and covers all types of medical devices.
Before the release of the ISO 13485 standard, there were the following standards, which include medical device manufacturers, but have been revoked today:
<br>• TS EN 46001 Quality systems - Medical devices - Particular requirements for the application of the EN 29001 standard
<br>• TS EN 46002 Quality systems - Medical devices - Particular requirements for the application of the EN 29002 standard
Both standards defined the quality system requirements for the manufacture and installation of medical devices where appropriate. ISO 9001 Medical Devices Quality Management System has been established to implement these two standards together with ISO 13485 Quality Management System standard. The most important benefit of the companies producing medical devices in their facilities is to establish the basis of the CE marking system which is compulsory for all medical devices. In other words, all manufacturers who want to get CE Certificate to their products must start by setting up ISO 13485 standard.
In addition to building infrastructure for CE marking, ISO 13485 Medical Devices Quality Management System has other benefits. For example, compliance with existing legal regulations is ensured. As it is a quality system, quality awareness is placed on the employees. Naturally, customer needs and expectations are met and customer satisfaction is created. It provides the opportunity to intervene quickly in the production processes. In addition to preventing incorrect products from being released to the market, it is also prevented to recall faulty products from the market. The company's costs are falling, profit and productivity is increasing. The firm's market share is increasing and its competitiveness is increasing. The company gains reputation and prestige in domestic and foreign markets.
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