Medical device manufacturers need to establish and certify a quality system in order to meet the requirements of current legal requirements, to ensure customer satisfaction, to increase internal efficiency and to provide legal assurance against lawsuits. EN 46001 / ISO The 13485 Management System includes additional special requirements for manufacturers of medical devices, including ISO 9000 Quality Management requirements.

ISO 13485: 2003 is based on the ISO 9001: 2000 standard and replaces the previous 1996 version. Its main purpose is to ensure the global compliance of medical devices with quality rules. So; is a standard that defines the specific requirements for quality systems for manufacturers operating in the field of manufacturing, trading and distributing medical devices.

ISO 13485: Although 2003 is a special standard for Medical Devices, ISO 9001: has been designed in accordance with the infrastructure of 2000. However, it differs from ISO 9001: 2000 standard in some specific subjects. Just as in ISO 9001, this new management system shifts from a classic quality control approach to a process / process based approach; It aims to establish a direct link between the main objectives of the organization and productivity.

ISO 13485 Medical Devices Quality Management System is based on ISO 9001 Quality Management System published by International Standards Organization. It is based on the ISO 9001 standard. In fact, the quality standard is a standard that encompasses organizations from all sectors in order to ensure the systematic management of enterprises. However, there have been cases where this standard is not sufficient on a sectoral basis.

In particular, it cannot be said to meet all requirements in the field of medical devices, which is a very different field. Starting from this need, International Standards Organization has focused on creating sectoral standards. The ISO 2012 Medical Devices Quality Management System standard, which was revised in 13485, was prepared for this purpose and is the version of the ISO 9001 Quality Management System standard adapted to medical devices and developed in this field. 

In other words, all manufacturers who want to get CE Certificate for their products, have to start by establishing ISO 13485 standard. In addition to building the infrastructure for CE marking, the ISO 13485 Medical Devices Quality Management System has other benefits. For example, compliance with existing legal regulations is achieved. As it is a quality system, quality awareness is placed in 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 the introduction of faulty products, recalling faulty products from the market is also prevented. The company's costs are decreasing, profit and productivity are increasing. The company's market share is increasing and its competitiveness is increasing. The company is gaining reputation and prestige in domestic and foreign markets.

The ISO 13485 system is a standard that addresses companies in the medical sector and is generally applied to meet the regulatory requirements applicable to medical devices' services. Compliance with the ISO 13485: 2003 standard criteria also ensures compliance with the ISO 9001: 2000 standard, but it can be mentioned if all the items related to the ISO 9001: 2000 standard are fully implemented.

The two standards are very similar, except that the ISO 13485: 2003 standard also contains guidelines for medical devices. During the system works, confidence can be given in terms of quality within the framework of the policy determined by the management. As a result, ISO 13485: 2003 Standard certification is a symbol of prestige and trust, with policy text set by managers.

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