Quality system certification

Certificating quality systems according to ISO 9001 and 13485 standards under the professional control of NAH accreditation body

About ISO 9001

neoEMKI has significant experience about certifying medical device manufacturers and their products based on ISO 9001 and 13485. neoEMKI undertakes certification request according to ISO 9001 also from non-medical organisations (manufactures other than medical devices).

ISO 9001 is a determining member of ISO 9000 series of standards. ISO 9001 standard contains the requirements regarding quality system.

Being an accredited body by NAH (Hungarian Accreditation Authority), during certificating according to standards EMKI investigates the conformity of manufacturer’s or service provider’s quality system for the requirements of standard. After a successful certification (auditing) EMKI issues a certificate, so as to prove that quality system, developed as per ISO 9001, operates according to requirements.

About ISO 13485

Worldwide headway of standardized regulation requirements more and more demands development such a standard about medical devices, which can be used by all medical device manufacturers and guarantees safety and performance of products.

Medical device manufacturers expect that they can introduce and maintain effective quality system, in accordance with directives about medical devices (Directives 93/42/EEC – MDD, 98/79/EC – IVD and 90/385/EEC – AIMD).

Adaptation of ISO 13485 is voluntary for medical device manufacturer, however it is inevitable requirement on the significant part of the market to prove having the system.

ISO 13485 standard describes the main requirements of a quality system for the manufacturer of a medical device. With compliance of the standard, the organisation can prove that it can constantly manufacture medical devices and prove related services which fulfil statutory requirements and comply with its intended use.

ISO 13485 directive, accepted by CEN, is concordant with 93/42/EEC about medical devices, 90/385/EEC about implantable medical devices and 98/79/EC about In vitro diagnostic medical devices. Usage can prove compliance of statutory requirements and ensures perspicuous document handling and common language.

For suppliers of medical device manufacturers, in most cases, conformity for ISO 13485 directive is the only way to prove conformity of relevant requirements. ISO 13485 certification has great importance not only in Europe but also anywhere in the world.

Certificating of quality system can be initiated by filling MDD / ISO request form