• сертификация ISO 13485

    ISO 13485:2016 international certification

ISO 13485:2016 international certification

medical devices quality management systems standard 

ISO 13485 certification in Russia with IAF international accreditation

United Kingdom Accreditation Service

IAF certification in Russia and CIS - ISO 13485

International Accreditation Forum


ISO 13485 certification

what you can get

 

AJA EUROPE representative in Russia suggests you:

 

  • Competitive price for ISO 45001 certification; 
  • IAF transfer opportunities,
  • UKAS accredited certification (check AJA EUROPE accredition of UKAS (pdf.),
  • Registration at AJA EUROPE register of certified organizations (open register)
  • Oppotunity to use ISO 13485 conformity mark of AJA EUROPE after certification, 
  • Personal manager in Russia responsible for cooperation with you,
  • Other business support.

 

 

IAF accredited certification ISO 134852016 in Russia and CIS

ISO 13485:2016 requirements

general information

Based on the model and the provisions of a single high-level structure of the International Organization for Standardization, the standard governs the construction of a quality management system for enterprises producing honey. products (e.g. equipment, tools, etc.). Validation processes are strictly regulated, monitoring the quality of the goods after delivery, managing the technical file (technical conditions) for honey. products and a number of others specific to the production of honey. product processes. The appendix contains a comparative table of requirements for versions 2016 and 2003, which is useful for enterprises that have already implemented the requirements of the previous version of the standard in their activities.

ИНТЕРЕСНЫЕ ФАКТЫ

 

ISO 13485 is applicable for manufacturing, design and development and servicing companies.

 

ISO 13485 is required for product certification of medical devices in the scope of CE marking certification procedure

 

The U.S. also requires conformity to ISO 13485 during medical devices registration procedure

 

 

 


What ISO 13485 gives you

implementation and certification can help you

 

  • To provide at your enterprise a quality system consistent with best practices in the production of medical devices and software;
  • Get CE marking on medical devices;
  • Ensure the withdrawal of medical devices of varying complexity abroad, including to the EU countries, Turkey, Egypt, the United States and a number of others where the manufacturer requires a quality management system recognized by the industry and legislative standards, confirmed by international documents (for example, our certificate);
  • Show customers, partners, investors, authorities the ability of your company to produce high-quality and safe medical products;

  • Prepare for licensing by the supervisory authorities of the Russian Federation and the EAC.

  • Integrate specific aspects of medical device production management into the organization’s overall management system due to the high integration of provisions with such generally accepted documents as 9001, 14001, etc.

AJA EUROPE ISO 13485:2016 certification

Why cooperate with us

 

  • The ISO 13485 certificate with UKAS accreditation is recognized worldwide. We conduct an assessment according to ISO 13485 with the recognized and respected international accreditation UKAS (the UK), IAF member. The certificates issued to you by AJA EUROPE will support your recognition in any country and by any partner or client;

  • Our auditors are professional and are near you. AJA EUROPE auditors meet the highest competency requirements. Our policy of working with an auditor provides our clients from Russia, Belarus, Kazakhstan and other countries with additional value from the audit due to the competence of auditors.

  • We always try to suggest reasonable and a competitive price of ISO 13485 certification. Contact us and get the opportunity to optimize your costs;

  • You will know who to contact with your ISO certification question. Each client is assigned a personal manager who will work with you both during the preparation and conduct of audits, and at other times.

  • They trust us. Nobody can just buy an ISO 13485 certificate. Certificates are issued after the audits in accordance with international accreditation rules, which is reflected in the issued ISO 13485 Certificate. Your customers will accept the certificate and for them it will guarantee that you comply with the requirements of ISO 13485.

  • You will be able to pass certification to various standards. You can not only get the ISO 13485 certificate with accreditation, but also pass an integrated assessment, having received international ISO certificates according to several standards (45001, 14001, 22000,9001).

ГОСТ ISO 13485-2017

national standard

In Russia, the national version of the standards of the International Organization for Standardization was published in 2017.


The text of the national standard is identical to the international one (has the IDT statute). On our site you can download GOST ISO 13485 for review for free.


Passing the conformity assessment according to national GOST is carried out by bodies accredited by the Federal Accreditation Service of the Russian Federation (RosAccreditation). Only the results of such checks are taken into account when registering products in Russia.


Your next actions

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