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ISO 13485-2011 (ISO 13485: 2003)
Medical devices. Quality management systems. Requirements for regulatory purposes

The international standard, which is intended to assist companies producing medical products to develop a quality management system, provides the production of high quality products, effective assessment of the risks arising in the course of manufacture of medical devices.

The provisions of ISO 9001 were laid down to the basis of the present standard, hence, most of the requirements in them are identical. However, the content of the new standard did not include certain principles of ISO 9001, that regulate the process of continuous improvement and consumers complaints satisfaction, that according to the authors, are not relevant to the specific industry.

ISO 13485-2011 brings a fundamentally new requirements for technical equipment, the organization of production and storage facilities, hygiene staff. Criterions for compliance with the order of work, production processes and monitoring of their implementation are more strict.

The benefits of implementation and certification:

  • possibility of realization of manufactured goods outside the country;
  • the formation of a positive image and establishment of the stable company operating in accordance with international requirements reputation;
  • additional bonus at the time of participation in competitions and tenders for the right to receive state orders for the release of medical devices;
  • loyalty of consumers and regulatory bodies;;
  • demonstration of confidence in the consistently high product quality and level of provided services to business partners, customers, bodies of control and supervision.

GOST R ISO 13485 - 2011Standard focused on organizations producing various medical products. Such products include machinery, tools and other items used for the diagnosis, prevention, inspection, monitoring, treatment of diseases and pain relief, injury and disability.

If you need this type of certification, contact the certification body«SMK STANDART».

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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.

If you have additional questions – contact our specialists by phone +442035146935.