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What is GOST R ISO 13485-2011 and who should get it

Russian GOST R ISO 13485-2011 and international ISO 13485:2003 are included in the international standard system of ISO 9001. Full name of the Russian standard is GOST R ISO 13485-2011 “Medical devices. Quality management systems. System requirements for regulatory purposes”.

The main demands of international standard ISO 13485:2003 are based on ISO 9001 requirements. However, due to the fact that ISO 13485 is completely devoted to medical devices and related services, it contains the set of requirements involving different spheres of the industry, for example: requirements for warehouses; hygiene requirements for personnel, equipment and locations; mechanism of product withdrawal from the market in case of its negative impact on human health.The following features of ISO 13485 can be distinguished:
• more stringent requirements in respect of validation, production management, metrological support, personnel management, documentation;
• there are no requirements to demonstrate continuous improvement. ISO 13485 only demands the certified organization to show effective implementation and supporting of quality system;
• there are no requirements for assessing customer satisfaction;
• requirements for not only specific processes validation but all manufacturing processes;
• the standard suggests the greater emphases on the application of statistical methods, which allow not only to improve the product quality, but also to optimize the process.

Companies for which it is advisable to implement GOST R ISO 13485-2011 with assistance of “SMK-STANDART” specialists:
• manufacturing medical equipment and devices under private brand and wishing to place their products on Russian market independently;
• engaging only in developing of medical technologies;
• developing software for medical equipment;
• manufacturing parts of medical equipment.

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How to receive the certificate?

The applicant provides to the certification bode «SMK STANDART» the filled application form for obtaining the certificate by means of filling of a form on our site.

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