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DOCUMENTS REQUIRED FOR ISO 13485 APPLICATION

ISO 13485: The 2012 standard is a version of the ISO 9001 standard with special requirements for medical devices. The ISO 13485 standard is also important for CE marking as it is an important competitive advantage for medical device manufacturers to have CE certification.

The eighth of the appropriate evaluation modules in the CE marking system is the Full Quality Assurance Module (Module H). If the manufacturers of medical devices prefer the H module when they go to the CE marking, the ISO 13485 standard must be established in the enterprise.

 

In the CE marking system, the Full Quality Assurance module is concerned with both design and production steps. In order to implement this module, a certification body audits the scope of the Quality Management System's design, development, production, installation and after-sales service. The ISO 13485 standard is based on the ISO 9001 standard, but has become a standard for medical device manufacturers, especially with different demands from the design stages. This standard defines certain requirements for quality systems for companies operating in the field of manufacturing and trading of medical devices. It covers the project, production, installation and procurement phases of medical devices and related services. All companies operating in these areas, ISO 13485. Establish and manage Medical Devices Quality Management System. If these companies want to demonstrate and prove their capabilities in the production of medical devices, provision of related services, meeting customer needs and expectations and not violating the relevant legal regulations, they have to install this system in their enterprises and obtain ISO 13485 Certificate.

To obtain ISO 13485 Certificate, it is necessary to apply to an accredited certification body. At the time of application, the application form provided by the certification body must first be completed. The certification body conducts its first assessment on this form and prepares a draft contract covering the terms of service. After this agreement is signed, certification works begin. For these studies, the company should open all the documents prepared during the system establishment to the certification body. In addition, there is no other document to be submitted to the certification body. The certification body first starts a preliminary study via this documentation. If during the pre-audit the company identifies deficiencies and errors, they are asked to complete them. Field inspections do not begin until they are completed. Pre-inspection complete

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The firm, which provides auditing, supervision and certification services to internationally recognized standards, also provides periodic inspection, testing and control services.

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