ISO 13485: The 2012 standard is a version of the ISO 9001 standard with special conditions for medical devices. Having CE certificate for medical device manufacturers is an important competitive advantage, as it is the basis for CE marking ISO 13485 standard is also important.
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 stages. In order for this module to be implemented, a certification body inspects the Quality Management System's design, development, production, installation and after-sales service coverage.
The ISO 13485 standard is based on the ISO 9001 standard, but it has taken the form of a standard for medical device manufacturers with different demands, especially in design phases. This standard defines certain conditions that quality systems for companies operating in the field of production and trade of medical devices must provide. It covers the project, production, installation and procurement stages of medical devices and their services. All companies operating in these areas can establish and manage ISO 13485 Medical Devices Quality Management System. If these companies want to show and prove their capabilities in the production of medical devices, in providing related services, in meeting customer needs and expectations, and in the case that the related legal regulations are not being acted upon, ISO 13485 Certificate must take.
It is necessary to apply to an accredited certification body in order to obtain ISO 13485 Certificate. During the application, first of all the application form provided by the certification body must be filled in completely. The certification body, which makes its first assessment on this form, prepares a draft of the contract that covers the terms of service. After this contract is signed, the certification work begins. For these works, the company must open all documents prepared by the company to the certification body. Apart from this, there are no other documents to be given to the certification body.
The certification body first initiates a preliminary study through this documentation. If they identify the company's deficiencies and errors during the preliminary audit, they are asked to complete them. Field checks will not start before they are completed. After the pre-audit is completed, the actual field inspections to be carried out in the company's offices and production facilities begin.
our company TÜRCERT Technical Control and Certification The company provides fast, high quality and reliable consultancy services to all medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate in their companies. ISO 13485 Medical Devices Quality Management System If you have any doubts about which documents are needed to obtain the certificate, we are always with you as a company.