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ISO 13485 CERTIFICATION PROCESS

ISO 13485: 2012 standard ISO 9001: 2008 standard is based on the international standard with special requirements for Medical Devices. ISO 13485 is a system that can be used by manufacturers of medical devices when going to CE marking, which must be installed by companies who prefer H module within the scope of CE marking. Based on the ISO 9001: 2008 Quality Management System, it has become a standard for medical device manufacturers, especially with additional requests at the design stage.

ISO 9001: Based on the 2008 process approach model, this standard encompasses more stringent and specific quality system requirements than ISO 9001 that organizations need to comply with to provide medical devices and related services, and to demonstrate consistently the ability to meet customer and regulatory requirements applicable to medical .

 

ISO 13485, which defines the specific requirements for quality systems for organizations operating in the field of trade and manufacture of medical devices, ISO XNUMX, can be applied by all organizations involved in the project, production, installation and supply phases of medical devices or related services.

The steps for establishing the ISO 13485 standard in the enterprise are not different from the ISO 9001 standard. As a result, this system is also a quality system. The most important feature is the completion of the documentation work. The company's quality policies and objectives should be defined, business processes and work flow charts should be prepared, implementation instructions should be prepared showing how the work will be done, job descriptions and powers and responsibilities of the employees should be determined, how the processes will be audited and corrective and preventive actions should be defined.

After the preparation stages are completed and the system is put into practice, the company must apply for a certificate by applying to a certification body. At this point, it is important that the certification body to be selected is accredited by a national or international accreditation body.

The certification body conducts a preliminary audit of the documentation first. If no discrepancies are detected during this period or after the discrepancies are resolved, field inspection starts in the firm's office and production facilities. When this audit is completed, ISO 13485. ISO 13485 Medical Devices Quality Management System Certificate is issued and delivered.

The ISO 13485 Medical Devices Quality Management System was published by the International Standards Organization and was recently revised in 2012. The change is not significant. Only a number of changes have been made in the preamble of the standard and in Appendix Z.

 

Certification

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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