Certification of quality management systems in accordance with GOST R ISO 9001, GOST R ISO 13485

The implementation of quality management system (QMS) plays a major role in ensuring of release of qualitative and safe products with high operating characteristics. If quality management system has been implemented in the company, a certification organization checks and assesses this system and confirms that the company, with the help of the quality management system, is able to assess the product conformity with the determined requirements and to maintain this conformity.

Certification of quality management systems in Russia is conducted in accordance with the following standards:

  • GOST R ISO 9001-2001 Quality management systems. Requirements., this standard is harmonizedwith the International Standard ISO 9001:2000;
  • GOST R ISO 13485-2004 Medial devices. Quality management systems. System requirements for regulatory purpose, this standard is harmonized with the International Standard ISO 13485:2003. This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. The application of the standard GOST R ISO 13485is sufficient for organizations that produce medical devices only. This International Standard is a stand-alone standard.

Now Certification Centre of Medical Equipment VNIIMP is getting the accreditation for the right of conducting the certification of quality management systems in accordance with GOST R ISO 9001-2001, GOST R ISO 13485-2004. Our staff members have been already accredited as expert-auditors in QMS-certification (in GOST R system) by GOSSTANDART of Russia (now as Federal Agency on Technical Regulating and Metrology) and as auditors in QMS-certification by TGA, Germany. In addition, our expert-auditors have a great experience in conducting QMS-certification. They have taken part as a freelance auditors in a lot of certification audits, conducted by Institute for Certification and Testing EUROCAT, .

If you are interested in our QMS-certification service, please, fill in The questionnaire for QMS-certification and send it by e-mail or by fax to us. We will review your documents, assess the opportunity of the certification and define the cost, terms and conditions of QMS-certification process. If our conditions are acceptable for you, please, fill in The application for QMS-certification. We will make a contract for conduction the certification of your quality management system. Also you should prepare the set of documents according to The list of the documents, required for QMS-certification. Certification Body will review these documents before a certification audit of your organization is conducted.

Please, do not hesitate to contact us by phone +7 (495) 611-17-00, 611-17-38 if you have any questions. Contact persons: Mashkov Aleksander Vladimirovich, the director of ANO CCME VNIIMP, Stepanov Vitaliy Nikolaevich, the head of Quality department. Also you could make a request/order a certification service at our website item Make a request.

Attached files:

file size last edited
The questonnaire for QMS-certification 79.5 kb 11.03.2020 download
The application for QMS-certification 35.5 kb 11.03.2020 download
The list of the documents, required for QMS-certification 42 kb 11.03.2020 download